Preliminary Experience Research Articles

#2578 Safety profile of dapagliflozin therapy in the kidney peritransplant period

Abstract Background and Aims Sodium-glucose cotransporter 2 inhibitors (SGLT2i) are a class of glucose-lowering drugs that have demonstrated important cardio- and nephroprotective effects. These effects, according to preclinical data, may include attenuation of ischemia/reperfusion injury due to downregulation of pro-inflammatory cytokines and necroptosis mediators. This effect could be critical in the peritransplant period, protecting the allograft and potentially reducing delayed graft function (DGF). However, administration of SGLT2i immediately after deceased-donor kidney transplantation (KTx) could potentially be associated with adverse outcomes, such as urinary tract infections (UTI). We report the results of the first 10 patients of an ongoing study aimed at describing the safety profile of dapagliflozin in the peri-KTx period. Method Prospective, uncontrolled pilot study of consecutive, incident KTx patients that received a daily dose of dapagliflozin 10 mg, starting immediately before surgery and continuing until completing the first week post-transplant. All subjects provided informed consent for the study. Those with liver dysfunction, known allergy to SGLT2i, programmed for live-donor or multiorgan kidney transplantation or unable to provide informed consent were excluded. The primary outcome was the development of UTI during index hospitalization, defined either as a positive urine culture and/or symptoms suggestive of UTI. For comparison purposes, a retrospective sample of age- and sex-matched patients that received a KTx prior to the start of this study was included in this analysis. Two controls were selected for each case. Results Demographics and clinical characteristics of both patients in the study and retrospective controls are summarized in Fig. 1. Recipients that received dapagliflozin had similar rates of UTI when compared to controls, and were prescribed less frequently antibiotic therapy for UTI, although none of these differences reached statistical significance. Most cases of both groups consisted in asymptomatic bacteriuria. Of all four cases of documented UTI among treated patients, only one subject developed UTI during the days of dapagliflozin administration (the first 7 days after surgery). This patient did not require antibiotic therapy. The other three cases developed UTI after dapagliflozin discontinuation. Conclusion Results of this preliminary and limited experience lead us to believe that dapagliflozin in the peritransplant period may be a safe and feasible therapy that could help protect the renal allograft from ischemia/reperfusion injury.

Perspectives and preliminary experiences of psychedelics for the treatment of eating disorders: A systematic scoping review.

Research regarding the therapeutic application of psychedelics and psychedelic-assisted psychotherapy in the treatment of eating disorders (EDs) has begun to emerge. This systematic scoping review aimed to map and synthesise the existing evidence regarding the participant reported efficacy and perspectives concerning psychedelics in the treatment of EDs, and to identify significant research gaps. A systematic search was undertaken across several databases in accordance with Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews guidelines. 1290 publications were identified, 1135 after duplicates removed, with 17 meeting full-eligibility criteria. Overall, findings suggested that most participants reported experiencing a meaningful reduction in their ED symptoms and having positive experiences or an openness to explore psychedelics as a treatment for ED symptoms, although some noted concerns of adverse effects and the importance of having psychological support to increase safety and efficacy. While preliminary research suggests psychedelics and psychedelic-assisted psychotherapy may be a viable treatment option for ED symptoms, further research with more robust research designs is required to increase confidence in its efficacy, generalisability, and safety as a therapeutic medium.

Implantation of a novel insertable cardiac monitor: preliminary multicenter experience in Europe.

The LUX-Dx™ is a novel insertable cardiac monitor (ICM) introduced into the European market since October 2022. The aim of this investigation was to provide a comprehensive description of the ICM implantation experience in Europe during its initial year of commercial use. The system comprises an incision tool and a single-piece insertion tool pre-loaded with the small ICM. The implantation procedure involves incision, creation of a device pocket, insertion of the ICM, verification of sensing, and incision closure. Patients receive a mobile device with a preloaded App, connecting to their ICM and transmitting data to the management system. Data collected at European centers were analyzed at the time of implantation and before patient discharge. A total of 368 implantation procedures were conducted across 23 centers. Syncope (235, 64%) and cryptogenic stroke (34, 9%) were the most frequent indications for ICM. Most procedures (338, 92%) were performed in electrophysiology laboratories. All ICMs were successfully implanted in the left parasternal region, oriented at 45° in 323 (88%) patients. Repositioning was necessary after sensing verification in 9 (2%) patients. No procedural complications were reported, with a median time from skin incision to suture of 4min (25th-75th percentiles 2-7). At implantation, the mean R-wave amplitude was 0.39 ± 0.30mV and the P-wave visibility was 91 ± 20%. Sensing parameters remained stable until pre-discharge and were not influenced by patient characteristics or indications. Procedural times were fast, exhibited consistency across patient groups, and improved after an initial experience with the system. Operator Operator feedback on the system was positive. Patients reported very good ease of use of the App and low levels of discomfort after implantation. LUX-Dx™ implantation appears efficient and straightforward, with favorable post-implantation sensing values and associated with positive feedback from operators and patients.

GUIDEWIRE SHAPE MODIFICATION: A SIMPLE TECHNIQUE TO PREVENT CONDUCTION SYSTEM INJURIES DURING TRANSCATHETER VALVE IMPLANTATION

Abstract Background Atrioventricular (AV) conduction abnormalities remain one of the important unsolved issues with transcatheter aortic valve implantation (TAVI). To minimize trauma on the conduction fibers, we introduced a simple technique involving the bending of the stiff guidewire wire at the level of the arch to prevent and minimize contact with the interventricular septum. Aim To report the technique for shape manipulation of the stiff guidewire during TAVI and to evaluate its safety and effectiveness in reducing the need for permanent pace–make implantation after TAVI. Methods and Results Before insertion into the left ventricle the TAVI stiff wire was bended by hand to obtain a ³180° degree curve 15–20cm from its tip. Distance between stiff wire and septum was assessed in cranial–lao cusp overlap projection. Among 26 consecutive patients who underwent TAVI with a bended stiff wire, 13(50%) presented preoperative factors of increased risk for need of PM implantation after TAVI due to LVOT calcification (10, 38.5%), bicuspid aortic valve with raphe opposite to the septum (2, 7.7%) and baseline RBBB (2, 7.7%). Wire was observed to be distant from the septum >5mm in 22/26 (85%) cases. Median distance from septum was 9.0 [6.0, 12.0] mm. Pre–dilatation was required in 20 patients (77%). Balloon was observed to inflate distant from septum in 18 (90%) of them. Self–expandable valves were most frequently employed (n = 21, 81%).No patient required new PM implantation after TAVI. The two patients with baseline RBBB developed transient complete AVB, which recovered before discharge.No major complication (vascular, ventricular perforation, annular rupture, device embolization) was observed. Conclusions In this early preliminary experience stiff wire bending was able not only to keep far from the septum the wire in the majority of patients, without any complication, but also to provide wire stability and prevented inadvertent pressure of the wire over the left ventricular apex. No patient required PM implantation after TAVI. While wire bending seems promising in minimizing trauma on the conduction system, this study is to be considered hypothesis generating and more data are needed to confirm its findings.

Sentinel Lymph Node Mapping in Lung Cancer: A Pilot Study for the Detection of Micrometastases in Stage I Non-Small Cell Lung Cancer.

Lymphadenectomy represents a fundamental step in the staging and treatment of non-small cell lung cancer (NSCLC). To date, the extension of lymphadenectomy in early-stage NSCLC is a debated topic due to its possible complications. The detection of sentinel lymph nodes (SLNs) is a strategy that can improve the selection of patients in which a more extended lymphadenectomy is necessary. This pilot study aimed to refine lymph nodal staging in early-stage NSCLC patients who underwent robotic lung resection through the application of innovative intraoperative sentinel lymph node (SLN) identification and the pathological evaluation using one-step nucleic acid amplification (OSNA). Clinical N0 NSCLC patients planning to undergo robotic lung resection were selected. The day before surgery, all patients underwent radionuclide computed tomography (CT)-guided marking of the primary lung lesion and subsequently Single Photon Emission Computed Tomography (SPECT) to identify tracer migration and, consequently, the area with higher radioactivity. On the day of surgery, the lymph nodal radioactivity was detected intraoperatively using a gamma camera. SLN was defined as the lymph node with the highest numerical value of radioactivity. The OSNA amplification, detecting the mRNA of CK19, was used for the detection of nodal metastases in the lymph nodes, including SLN. From March to July 2021, a total of 8 patients (3 female; 5 male), with a mean age of 66 years (range 48-77), were enrolled in the study. No complications relating to the CT-guided marking or preoperative SPECT were found. An average of 5.3 lymph nodal stations were examined (range 2-8). N2 positivity was found in 3 out of 8 patients (37.5%). Consequently, pathological examination of lymph nodes with OSNA resulted in three upstages from the clinical IB stage to pathological IIIA stage. Moreover, in 1 patient (18%) with nodal upstaging, a positive node was intraoperatively identified as SLN. Comparing this protocol to the usual practice, no difference was found in terms of the operating time, conversion rate, and complication rate. Our preliminary experience suggests that sentinel lymph node detection, in association with the accurate pathological staging of cN0 patients achieved using OSNA, is safe and effective in the identification of metastasis, which is usually undetected by standard diagnostic methods.

Blockchain and industrial symbiosis: a preliminary two-step framework to green circular supply chains

AbstractThe strategic management of supply chains, by ensuring closed-loop manufacturing processes and a constant reduction of industrial waste, is an essential pillar of sustainability. This is the pattern behind the, so-called, circular supply chains. The effective adoption of this paradigm demands the supply chains actors to establish robust integration and relationships, so that waste and by‐products of an industry or industrial process become the raw materials for others. This circular network is defined as industrial symbiosis. Starting from a background on this topic, this working paper explores the potential of blockchain as enabling technology of Industry 4.0 to disseminate industrial symbiosis practices within the modern industrial scenario. A preliminary two-step framework, i.e., conceptual and operative, is presented including insights and win–win synergies showing the potential of blockchain technology in supporting informative flows of industrial symbiosis. Preliminary field experiences are suggested, along with existing limitations and perspectives on future research.

The Melody Valve in Small Children Undergoing First Mitral Valve Replacement: Better Than Mechanical?

BackgroundIn small children with left atrioventricular valve dysfunction, valve repair is preferred but some will require valve replacement. No prosthetic valve has growth potential, bioprostheses have poor durability, and mechanical prostheses have high rates of thromboembolic and hemorrhagic complications. We reviewed our experience with a modified bovine jugular vein valve designed for use in the right ventricular outflow tract (Melody valve, Medtronic) and compared this with contemporary mechanical valve replacement. MethodsWe reviewed outcomes of all left-sided atrioventricular valve replacements (AVVR) performed between January 2017 and April 2023 on patients with biventricular circulation less than 5 years old at time of surgery, N = 19. We compared mortality and major morbidity outcomes between mechanical AVVR (mAVVR, n = 14) and Melody AVVR (MAVVR, n=5). ResultsMAVVR was performed on younger and smaller patients (5.7 ± 4.2 vs 28.4 ± 22.3 months, P = .002; 6 ± 1.7 vs10 ± 5.1 kg, P = .01). There were 2 early and 1 late death in the mAVVR group, and none in the MAVVR group. There was a trend towards more hemorrhagic and neurologic complications in the mAVVR group (P = .1, 0.28, respectively). ConclusionsIn this small series, despite its use in younger and smaller patients, our preliminary experience with the Melody valve compares favorably with our contemporaneous outcomes with mechanical prostheses by way of simpler anticoagulation management with a trend towards better overall outcomes.

Treatment of intracranial aneurysms with large-diameter (≥5.5 mm) Derivo Embolization Devices, with particular focus on 7 and 8 mm diameter devices.

There are few studies on flow diverters with diameters >5 mm. We present our preliminary experience with the 5.5-8 mm Derivo Embolization Device (DED) implants for the treatment of cerebral aneurysms. A consecutive series of 26 patients (median age: 60 years) treated for 32 aneurysms in 26 procedures was retrospectively analyzed for procedural characteristics, complications, and mid-term angiographic results. The median aneurysm size was 10.5 mm, 2 of 30 (6%) aneurysms were ruptured and 9 (28%) had a fusiform or dissecting morphology. DED implantation was performed in the internal carotid artery in 18 of 26 (69%) procedures and in the vertebrobasilar artery in 8 (31%). Device deployment failed in 1 (4%) procedure. The 7 and 8 mm implants were successfully deployed in 5 cases. Additional balloon angioplasty or stent implantation was performed in 3 (12%) cases to improve wall apposition. Complications included 1 (4%) major stroke and 2 (8%) minor strokes. Angiographic follow up at a mean of 6 months showed complete occlusion in 8 of30 (27%) aneurysms and favorable occlusion in 14 (47%). The use of large diameter DEDs was safe and feasible. The mid-term occlusion rates are acceptable considering the complex subset of aneurysms studied. Further studies are warranted to define the indications for large-diameter DEDs and to evaluate their long-term efficacy.

Multicentre Experience with Novel Bidirectional Double Cuffed Inner Branches for Complex Endovascular Aortic Repair

This study aimed to report the initial experience with a novel bidirectional double cuff inner branch design for incorporation of renal and mesenteric arteries in patients undergoing fenestrated and branched endovascular aortic repair (F/BEVAR). A retrospective review was undertaken of the experience of F/BEVAR with grafts integrating at least one bidirectional double cuffed inner branch implanted at three tertiary aortic centres between March 2022 and June 2023. All consecutive patients were included. Baseline characteristics, operative data, and follow up data were collected. Results were presented as number or median (interquartile range) unless otherwise stated. Thirteen patients (10 male; median age 72 [68, 77] years) had F/BEVAR using a total of 15 bidirectional double cuffed inner branches (30 cuffs). Indications for bidirectional doubled cuffed inner branches included cranial vessel orientation or double renal arteries in four patients each, common coeliomesenteric trunk in three patients, and early renal artery bifurcation, renal artery origin from a false lumen requiring a flexible route for catheterisation, and surplus configuration in one patient each. Twenty three of the 30 cuffs were used, whereas the remaining seven cuffs were intentionally occluded with vascular plugs. Target vessel incorporation was successful in all bidirectional branches. There was one technical failure related to unsuccessful catheterisation of a left renal artery targeted through a unidirectional caudal inner branch. During a median follow up of seven months there were no instances of target vessel instability or re-interventions and two patients died of causes unrelated to the bidirectional branches. The results of the use of bidirectional double cuff inner branches are promising, with high technical success and no short term branch related complications in this preliminary experience. This could potentially expand the applicability of branch endografting of complex endovascular aortic repairs, but long term results are still missing.

Abstract PO4-20-01: A PROSPECTIVE PILOT STUDY OF MAMMOGRAPHIC PREDICTION OF WOMEN’S RISK (M-POWER) IN NIGERIA

Abstract Background There have been no sustained efforts at stemming the rising incidence and mortality from breast cancer in sub-Saharan African countries like Nigeria. Mammography is the gold standard for breast cancer screening and is associated with improved survival particularly among women 50 to 69. Reports from various parts of Nigeria show very low mammography screening uptake. Causes include lack of geographical access, financial issues (less than 5% of the population is covered by the National Health Insurance Scheme), lack of awareness and the increasing expertise gap from the continued brain drain, despite the already low number of radiologists in the country. Given these obstacles, our long-term goal is to devise a rational basis for identifying mammographic risk categories so that this resource can be deployed cost-effectively. We propose to carry out a 5-year prospective mammographic study in Nigerian women and to use machine learning to develop a risk prediction algorithm, so that following a single screening mammogram, the appropriate frequency of subsequent mammograms can be determined. Our immediate goal is to examine the feasibility of performing such a study. To this end, we have initiated a cross-sectional pilot study that will recruit up to 2000 women in multiple urban centers in Nigeria. Objective: To explore feasibility of creating a digital mammography image database representative of the radiological features of the breast of Nigerian women. Objective: To explore feasibility of creating a database that can be used to inform a predictive mammographic risk model for breast cancer and identify the appropriate population that will benefit from breast cancer screening in Nigeria. Design This is a prospective, open-label, cross-sectional pilot study in 2000 eligible women in Nigeria and will include a single screening mammography examination. The mammography images will be read by the study radiologist. The Pilot phase will determine the feasibility and aid in the design of the of the Extension phase in which up to 20,000 participants will undergo yearly mammography examination for 5 years. Incident cases of breast cancer during the study period will permit the development of deep learning algorithms for predicting the risk of breast cancer in this population. Main Eligibility Criteria: Inclusion Criteria All consecutive women aged ≥40 years and < 65 years presenting for screening mammography at the participating institutions will be eligible. Signed study-specific written informed consent. Exclusion Criteria Complaint of a focal dominant lump or a bloody or clear nipple discharge. History of breast implants. Any woman who is pregnant or has reason to believe that she might be pregnant. Statistical Methods Analyses of continuous data will be summarized using descriptive statistics where the following parameters will be reported: Number of observations, Number of missing observations, Mean, Median, Standard deviation (SD), Minimum (Min), Maximum (Max) Categorical data will be presented with absolute and relative frequency (n and %). Present Accrual and Target accrual Two hundred ninety-six women have been enrolled and screening digital mammographic images using GE Digital mammography equipment have been obtained on all participants at 2 study sites in 2 cities in Southern Nigeria. The target accrual is 2000 participants over 12 months. Conclusion Our preliminary experience to date suggests the feasibility of proceeding with a larger prospective study to define mammographic risk groups in Nigerian women which will permit the rational allocation of resources for breast cancer prevention activities in this underserved population. Contact Information: Dr Toyin Shonukan at tshonukan@yemanjacancercare.org Citation Format: Oluwatoyin Shonukan, Hyelakumi Ibrahim, Esther Udoh, Wahab Egbeolu, Kanyinsola Oyeyinka, Jonas Haggstrom. A PROSPECTIVE PILOT STUDY OF MAMMOGRAPHIC PREDICTION OF WOMEN’S RISK (M-POWER) IN NIGERIA [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-20-01.

Abstract PO4-04-10: Selection criteria for second-line treatments after Cyclin-dependent kinase 4/6 inhibitors failure in Hormone Receptor positive metastatic breast cancer patients: the preliminary experience of the HERMIONE-13 trial

Abstract BACKGROUND: Cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) represent the standard of care for hormone receptor-positive (HR+)/Human Epidermal Growth Factor 2 negative (HER2-) metastatic breast cancer (MBC); no consensus actually exists for second-line (2L) treatments. The HERMIONE-13 trial evaluates the adopted therapeutic options after CDK4/6i failure and the potential factors that influence these choices. METHODS: HERMIONE-13 is a retrospective and prospective multicentric observational trial involving 15 Italian Centers. Information about therapies after disease progression to CDK4/6i from January 2016 until December 2020 was collected for the present analysis, aiming at evaluating which are the clinical criteria guiding the choice of 2L therapy after CDK4/6i failure. RESULTS: 114 pts have been enrolled: 14 pts (12.3%) received neoadjuvant treatment, 80 (70.2%) adjuvant therapy, of whom 46 (57.5%) chemotherapy (CT)+ endocrine therapy (ET) and 33 (41.3%) ET alone. Among the 79 pts treated with adjuvant ET, 44 pts (55.7%) showed primary or secondary endocrine resistance. 39 pts (34.2%) received first-line (1L) CDK 4/6i in combination with Fulvestrant (F), the remaining with aromatase inhibitors (AIs). Median duration of 1L CDK4-6i was 10.4 months (interquartile range (IQR) 4.7-17.4). Median age at 2L start was 59.5 years (IQR 51-68). As 2L therapy, 79 pts (69.3%) received CT±targeted therapy (TT) and 35 (30.7%) ET±TT. Visceral metastases at the beginning of 2L were documented in 46 pts (40.4%). Comorbidities were present in 48 (42.9%) of the pts, mainly cardiac diseases (25, 22.3%); 71 pts (63.4%) showed a 1L-related adverse events (AEs) (NA: 2 pts), mainly hematological toxicity (60, 53.6%). Among 79 pts treated with adjuvant ET, 60 (76%) were addressed to 2L CT±TT, while 19 (24%) to an ET-based therapy. A longer duration of 1L was observed in pts treated with 2L ET±TT (12.5 months, 7.2-22.2) in comparison with those treated with CT±TT (8.7 months, 4.2-14.9). The majority of pts treated with 1L F+CDK 4/6i underwent 2L CT-based treatment, as summarized in Table 1. Analyzing the population treated with 2L CT±TT, we observed that median age was 58 years (49-67), slightly lower than that of pts treated with ET±TT (63, 54-69). Among pts with visceral metastases, 30 pts (65.2%) were addressed to 2L CT±TT and 16 pts (34.8%) to ET±TT; CT±TT was also the favorite choice for the majority of pts with concomitant disease (33, 68.8%) and with previous CDK4/6i-related toxicity (47, 66.2%). Among age, visceral metastases, comorbidities, adjuvant treatment, duration of 1L therapy, use of 1L F and 1L related AEs, univariate analysis revealed that previous use of adjuvant ET (p=0.021), 1L F (p< 0.001), duration of 1L treatment (p=0.043) and age at 2L start (p=0.053) are all factors influencing the choice of 2L therapy. At the multivariate logistic regression model, only the use of F in association with CDK4/6i as 1L treatment and age at 2L therapy were associated with the choice between ET±TT vs CT± TT, with a backward selection, as summarized in table 2. CONCLUSION: The preliminary results of our study suggest that previous F in combination with CDK4/6i is a statistically confirmed predictor of choice for subsequent CT, whereas the increase in age is significantly associated with the choice for ET. Further research is needed to investigate the optimal sequencing of treatments following CDK4/6i and to determine predictive factors of response to 2L therapies. Table 1 2L choices in 1L F+CDK 4/6i pts. Table 2 Statistical model with the significant variables. Citation Format: Marina Elena Cazzaniga, Emanuela Rossi, Antonella Turla, Massimo Ambroggi, Alice Baggi, Rossana Berardi, Fulvio Borella, Serena Capici, Federica Cicchiello, Luigi Coltelli, Ugo De Giorgi, Antonella Ferro, Ornella Garrone, Monica Giordano, Elisabetta Landucci, Marco Mazzotta, Gabriella Moretti, Raffaella Palumbo, Francesca Fulvia Pepe, Patrizia Vici, Fable Zustovich, Viola Cogliati. Selection criteria for second-line treatments after Cyclin-dependent kinase 4/6 inhibitors failure in Hormone Receptor positive metastatic breast cancer patients: the preliminary experience of the HERMIONE-13 trial [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-04-10.

Shared Decision Making in Oncology and Its Implementation in Cervical Cancer Management in the Philippines: A Narrative Review.

Shared decision making (SDM) is an approach where clinicians and patients make decisions together using the best available evidence. Although much studied, recognized to be ethically imperative, and recommended in international health policies, it remains poorly implemented. In the Philippines, there are limited studies on patient decision making preferences and SDM. Practical guidance on the implementation of SDM or use of patient decision aids (PtDAs) is often not detailed in existing national clinical practice guidelines in oncology. We performed a systematic search of Philippine literature on SDM in oncology and an iterative review of international literature on the philosophy and methods of SDM, the utility and effectiveness of PtDAs, and the facilitators and barriers to implementation or usage. We contextualized our review to the cervical cancer management and health service delivery in the Philippines. Local literature is limited to five scientific publications and two registered studies. International literature encompasses patient decisional preferences, the role of PtDAs and the standards for their development and evaluation, their effectiveness, and barriers and facilitators to their use in cancer-related decision making. We discussed the implications on the management of cervical cancer in the Philippines, challenges in health service delivery and standards, and SDM research. Local SDM research is limited. Our preliminary experience in a multicenter clinical trial in Manila on PtDA use in the framework of SDM in cervical cancer suggest good patient and clinician acceptability. Challenges to implementation such as unfavorable financial situations, urgency of clinical decisions, low patient or caregiver educational attainment, and poor integration of multidisciplinary and SDM in organizational workflows will be important when implementing SDM in different settings.

1229: Preliminary experience in left breast breath-hold treatment with Hexamotion system.

1229: Preliminary experience in left breast breath-hold treatment with Hexamotion system.

Preliminary experience with lost mini percutaneous nephrostomy channel retrieval by methylene blue injection

Preliminary experience with lost mini percutaneous nephrostomy channel retrieval by methylene blue injection

Reliability of Ultrasonographic Assessment of Depth of Invasion and Tumor Thickness in Intraoral Mucosa Lesions: A Preliminary Experience.

Introduction: Despite the progress made in multidisciplinary care, there has been little improvement in the oncologic outcomes of oral cavity squamous cell carcinomas (OSCCs). In the latest edition of the TNM staging, "depth of invasion" (DOI) has recently been introduced as one of the criteria for determining the T stage, alongside other factors. DOI is widely recognized as an independent risk factor for nodal metastases and is a crucial consideration in the preoperative staging of OSCCs, along with measurements of tumor thickness (TT). While various diagnostic methods exist for assessing DOI, intraoral ultrasonography (IOUS) has gained popularity for its efficacy in evaluating OSCCs. Methods: This study sought to evaluate the diagnostic accuracy and reliability of ultrahigh-frequency ultrasound (UHFUS) in assessing oral cavity lesions compared to histopathological analysis. Results: The results revealed strong reliability in ultrasonographic measurements (ICC TT: 0.94; ICC DOI: 0.97) and distinct ultrasonographic features specific to different oral pathologies. This highlights the potential of UHFUS as a non-invasive imaging tool for precise diagnostic evaluations. Conclusions: Despite limitations such as a small sample size and focus on specific lesions, these promising results suggest that UHFUS could significantly enhance oral lesion diagnostics. Further research involving larger cohorts is necessary to validate and build upon these initial findings.

Is salvage Plug-Assisted Retrograde Transvenous Obliteration (PARTO) safe and effective for bleeding gastric varices ?- A preliminary single-center experience.

Vascular plug-assisted retrograde transvenous obliteration (PARTO) obliterates the gastric varices and portosystemic shunt, thus resulting in a lower rebleeding rate than endoscopic glue/sclerotherapy. To evaluate the safety and efficacy of PARTO as salvage therapy in liver cirrhosis with gastric variceal bleed (GVB) after failed endotherapy. We assessed the clinical success rate and changes in liver function at 6- months. Patients who underwent salvage PARTO after failed endotherapy for GVB (between December 2021 and November 2022) were searched and analyzed from the hospital database. Clinical success rate and rebleed rate were obtained at six months. Child-Pugh score (CTP) and Model for end-stage liver disease (MELD) score were calculated and compared between baseline and 6-month follow-up. Fourteen patients (n = 14, Child-Pugh class A/B) underwent salvage PARTO. Nine had GOV-2, and five had IGV-1 varices. The mean shunt diameter was 11.6 ± 1.6mm. The clinical success rate of PARTO was 100% (no recurrent gastric variceal hemorrhage within six months). No significant deterioration in CTP (6.79 ± 0.98 vs. 6.21 ± 1.52; p = 0.12) and MELD scores (11.5 ± 4.05 vs. 10.21 ± 3.19; p = 0.36) was noted at 6months. All patients were alive at 6months. One patient (n = 1, 7.1%) bled from esophageal varices after three days of PARTO and was managed with variceal banding. 21.4% (3/14) patients had progression of esophageal varices at 6months requiring prophylactic band ligation. Three patients (21.4%) had new onset or worsening ascites and responded to low-dose diuretics therapy. PARTO is a safe and effective procedure for bleeding gastric varices without any deterioration in liver function even after six months. Patient selection is critical to prevent complications. Further prospective studies with larger sample size are required to validate our findings.

Changing vistas of psychosis and antipsychotic drug dosing toward personalized management of antipsychotics in clinical practice.

To discuss current evidence on tapering antipsychotic drugs in view of changing vistas of psychosis, suggesting a provisional framework for safely tapering antipsychotic drugs to an optimal low dose, in collaboration with patients and their relatives, to promote functional recovery while preventing relapse. Paradigm shifts during recent years regarding the nature of psychotic disorders and the role of the dopamine system are discussed, including the positive effects of dopamine blockade in acute psychosis and the limitations and drawbacks of dopamine blockade regarding negative and cognitive symptoms after remission of positive symptoms. Recent advances in tapering strategies and upcoming ways to solve the dilemma between the need to prevent relapses with antipsychotics on the one hand and the need to minimize side effects by tapering these drugs on the other are presented. Modern tapering strategies appear to reduce relapse risk to acceptable levels and offer a feasible personalized option to find the least effective dose to treat and prevent positive symptoms without redundant side effects and functional incapacity. These findings need replication, and several trials that might provide more certainty are on their way. Preliminary evidence and clinical experience indicate that personalized dose reduction of antipsychotics is feasible and safe if carried out in close collaboration with patients and their relatives, according to a provisionally suggested framework presented here. These preliminary directions still must be confirmed, revised, and adjusted according to upcoming trial results. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Texture Analysis in [18F]-Fluciclovine PET/CT Aids to Detect Prostate Cancer Biochemical Relapse: Report of a Preliminary Experience

Background. As artificial intelligence is expanding its applications in medicine, metabolic imaging is gaining the ability to retrieve data otherwise missed by even an experienced naked eye. Also, new radiopharmaceuticals and peptides aim to increase the specificity of positron emission tomography (PET) scans. Herein, a preliminary experience is reported regarding searching for a texture signature in routinely performed [F18]Fluciclovine imaging in prostate cancer. Materials and methods. Twenty-nine patients who underwent a PET/computed tomography (CT) scan with [18F]Fluciclovine because of biochemical prostate cancer relapse were retrospectively enrolled. First- and second-order radiomic features were manually extracted in lesions visually considered pathologic from the Local Image Features Extraction (LIFEx) platform. Statistical analysis was performed on a database of 29 lesions, one1 per patient. The dataset was split to have 20 lesions for the model training set and 9 lesions for the validation set. The Wilcoxon–Mann–Whitney test was used on the training set to select the most significant features (p-value < 0.05) predicting the dichotomous outcome in a univariate analysis. Results. The best model for predicting the outcome was found to be a multiple logistic linear regression model with two features as variables: an intensity histogram type and a gray-level size zone-based type. Conclusions. Texture analysis of [F18]Fluciclovine PET scans helps in defining prostate cancer relapse in a daily clinical setting.

Feasibility and Safety of Bridging Antiplatelet Therapy with Cangrelor in Neuro-Oncology: A Preliminary Experience.

Antiplatelet therapy is mandatory for prevention of thrombotic events in patients with a recent history of acute coronary syndromes and/or percutaneous coronary interventions. However, if an urgent surgery is required during antiplatelet therapy, a compromise between the ischemic/thrombotic and hemorrhagic risk has to be reached. Different bridging schemes are reported in the literature, but there is no clear consensus on the optimal treatment strategy in terms of efficacy and safety. Although some indications about the perioperative management of antiplatelet therapy regarding specific surgical specializations are available, balancing the thrombotic and hemorrhagic risk on an individual basis, no evidence referring to neurosurgical or neuro-oncologic procedures is reported. Herein, we present our preliminary experience in the perioperative management of a patient who underwent a neurosurgical procedure for the resection of a primary malignant brain tumor using an intravenous P2Y12 inhibitor (cangrelor) as bridging therapy after a recent acute myocardial infarction treated with primary percutaneous coronary intervention and stenting. The oral P2Y12 inhibitor (clopidogrel) was withdrawn 5 days prior to the surgical procedure and continuous infusion of cangrelor was started 3 days before the surgery at a dose of 0.75 μg/kg/min. Cangrelor was discontinued 2 hours before surgery and resumed 72 hours after tumor resection for further 60 hours. Neither cangrelor-related bleeding nor cardiac ischemic events were observed in the perioperative period and the following 90 days, supporting data regarding the feasibility and safety of this bridging scheme. Further studies are needed to confirm our promising results.

Treatment of Aorto-iliac and Infrainguinal Vascular Infections with a Prefabricated Bovine Pericardial Graft

The use of biological grafts provides acceptable mid- and long-term results in native or prosthetic vascular infections. Several reports describe the successful use of bovine pericardium in case of vascular infections, mainly as a large patch to be sutured as a tubular graft. Recently, a novel prefabricated bovine pericardium graft (Biointegral Surgical No-React® Inc, Mississauga, ON, Canada) has been introduced in clinical practice with promising results. In this study, we report our preliminary experience utilizing Biointegral Surgical graft in case of native and or prosthetic aorto-iliac and infrainguinal infection. We retrospectively analyzed data from 20 patients with native or prosthetic aorto-iliac and infrainguinal infection who underwent in situ reconstruction (ISR) with a Biointegral Surgical No-React bovine pericardium prosthesis between October 2020 and February 2023 at the Vascular Surgery Unit of the Fondazione Policlinico Universitario Gemelli - IRCCS in Rome, Italy. All patients followed a standardized protocol including postoperative anticoagulation and long-term intravenous antibiotics. The indication for surgery was: mycotic aortic aneurysm in 4 patients (20%), graft infection after abdominal aortic repair in 11 patients (55%), peripheral graft infection in 5 patients (25%). Complete excision of the infected aorta or prosthetic graft, surgical debridement and ISR were performed in all patients. Hospital mortality rate was 5% (n=1) and graft-related mortality of 0%. During follow-up (median 13months, range 6-34months), reinfection was 5.2% and primary graft patency 94.7%. The use of prefabricated bovine pericardial grafts represents a promising option for the treatment of native and prosthetic aorto-iliac and infrainguinal infections. The application of this biological graft with a standardized postoperative protocol has been associated with a satisfactory patency and reinfection rate without increased bleeding complications.