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Marrie van der Mooren,1 Aixa Alarcon,1 Mark D Jenkins Sanchez,1 Daniel H Chang2 1Johnson & Johnson Surgical Vision, Inc., Groningen, Netherlands; 2Empire Eye and Laser Center, Bakersfield, CA, USACorrespondence: Marrie van der Mooren, Johnson & Johnson Surgical Vision, AMO Groningen BV, Van Swietenlaan 5, Groningen, 9728, NX, Netherlands, Tel +31620709324, Email Mvande97@its.jnj.comPurpose: To assess the experimental visual performance and dysphotopsia characteristics of the new Tecnis Symfony OptiBlue extended-depth-of-focus with violet light-filtering (ZXR00V) intraocular lens (IOL) compared with the colorless Tecnis Symfony (ZXR00) IOL.Methods: Range of vision was assessed with simulated visual acuity defocus curves, predicted by white light through focus modulation transfer function (MTF) measurements. The clinical visual acuity defocus curve of the ZXR00 IOL was used to validate the predicted range of vision. Image quality was compared by measuring white light MTF at a spatial frequency of 15 cycles per degree (c/deg) for 3 mm and 5 mm pupil diameters with optical powers of 5 D, 20 D, and 34 D using the average corneal eye (ACE) model with the average spherical and chromatic aberration of the cataract population. Effects on dysphotopsias were predicted by measurement and computer simulation of light scatter (straylight parameter) and subsequent determination of retinal veiling luminance (RVL) in vitro. Contrast enhancement under challenging light conditions was calculated based on the effects in RVL.Results: The simulated visual acuity defocus curves and image quality outcomes were comparable between the ZXR00V and ZXR00 IOLs. The area under the straylight curve for the straylight parameter showed a 19% improvement in halo performance with ZXR00V versus ZXR00. A 12% to 17% reduction in RVL was achieved in favor of ZXR00V over ZXR00, which enhanced contrast vision by 9% to 13% under challenging light conditionsConclusion: The violet light-filtering technology and improved manufacturing of ZXR00V delivers a comparable range of vision and tolerance to refractive error to ZXR00 while mitigating dysphotopsias and enhancing contrast vision.Keywords: dysphotopsia profile, presbyopia-correcting IOL, retinal veiling luminance, straylight parameter, violet light-filtering IOL

Daniel H Chang,1 Jerry Hu,2 Kevin M Miller,3 Srividhya Vilupuru,4 Wuchen Zhao4 1Empire Eye and Laser Center, Bakersfield, CA, USA; 2Texas Eye & Laser Center, Hurst, TX, USA; 3Department of Ophthalmology, David Geffen School of Medicine at the University of California Los Angeles (UCLA), Los Angeles, CA, USA; 4Johnson & Johnson Surgical Vision, Inc., Irvine, CA, USACorrespondence: Daniel H Chang, Empire Eye & Laser Center, 4105 Empire Dr, Bakersfield, CA, 93309, USA, Email dchang@empireeyeandlaser.comPurpose: To evaluate 3-month rotational stability, and visual and refractive outcomes of a toric intraocular lens (IOL) with frosted haptics.Patients and Methods: A post-market, prospective, multi-center, single-arm, open-label study conducted at seven clinical sites in the United States. Two hundred and two eyes of 133 subjects with unilateral or bilateral cataracts and corneal astigmatism were implanted with the Tecnis Toric II IOL, Models ZCU150 to 600 (Johnson & Johnson Surgical Vision, Inc.). Lens axis misalignment/rotation, visual acuity, manifest refraction, and surgeon and patient satisfaction were evaluated 3 months postoperatively. Lens rotation was determined with operative and postoperative visit photographs and was analyzed by two independent masked analysts.Results: Mean absolute lens rotation was 0.82° ± 1.00° and 0.94° ± 0.71° at 1 day (n = 189 eyes) and 3 months (n = 185 eyes), respectively. Absolute lens rotation was ≤ 5° in 98.9% and 100% of eyes at 1 day and 3 months, respectively. At 3 months, postoperative monocular uncorrected and corrected distance visual acuities were 0.004 ± 0.115 LogMAR (20/20) and − 0.066 ± 0.092 LogMAR (20/17), mean spherical equivalent was − 0.25 D ± 0.35 D and residual refractive cylinder was +0.27 D ± 0.33 D. Surgeons were satisfied/very satisfied with overall clinical outcomes and rotational stability in 99% of eyes, and with uncorrected distance vision in 98.5% of eyes.Conclusion: The study results demonstrate that the Tecnis Toric II IOL has excellent rotational stability with a high percentage of study eyes being within 5° of intended orientation. The study lens demonstrated excellent uncorrected distance visual acuity, reduction of cylinder, and exceptional patient and surgeon satisfaction.Keywords: toric IOL, lens rotation, IOL misalignment, residual astigmatism

Gabriel Quesada,1 Daniel H Chang,2 Kevin L Waltz,3 Andrew A Kao,2 Rodrigo Quesada,1 Ying Wang,4 Leilei Ji,4 Dari Parizadeh,4 Luis Atiles4 1Grupo Oftalmo & Plastico, San Salvador, El Salvador; 2Empire Eye and Laser Center, Bakersfield, CA, USA; 3Central American Ophthalmic Research Consultants, Indianapolis, IN, USA; 4Johnson & Johnson Surgical Vision, Inc, Santa Ana, CA, USACorrespondence: Gabriel Quesada, Grupo Oftalmo & Plastico, 9 C Pte, 4625, Col Escalon, San Salvador, El Salvador, Tel +1 (503) 22579003, Email gabriel.quesadalarez@gmail.comPurpose: The purpose of this first in-human study was to evaluate the overall clinical performance of the VERITAS™ Vision System in patients scheduled to undergo cataract extraction and to confirm overall surgeon acceptability.Patients and methods: This prospective, open-label multinational study included adults with cataracts scheduled for planned cataract extraction and posterior chamber IOL implantation. Standard small-incision phacoemulsification cataract surgery with the VERITAS Vision System was conducted. Surgeons completed a questionnaire regarding their clinical experience with the VERITAS Vision System for each patient following surgery and 1-day postoperative. Corneal clarity and adverse events (AEs) were assessed. Surgeon acceptability was scored on a 5-point scale, with acceptability considered favorable for scores of 4 and 5.Results: A total of 115 eyes (79 patients) were treated. The El Salvador site treated 41 patients (58 eyes), and the US site treated 38 patients (57 eyes). Overall, surgeons were satisfied with the clinical performance regardless of the cataract grade. The satisfaction with anterior chamber stability, post-occlusion surge, followability, holdability, cutting efficiency, usability, and overall satisfaction with the VERITAS Vision System was clinically favorable in ≥ 99% of cases. Overall satisfaction with the swivel handpiece, foot pedal, and enhanced ergonomics were clinically favorable in ≥ 97% of cases regardless of the cataract grade. Satisfaction with corneal clarity at same-day postoperative and 1-day postoperative, and 1-day overall clinical results of surgery with the VERITAS Vision System were clinically favorable in ≥ 94% of cases regardless of cataract grade.Conclusion: The new dual-mode phacoemulsification system with dual-durometer tubing, gas forced infusion, new swivel handpiece, and ergonomics improvements resulted in a high rate of user satisfaction with clinical performance and ergonomics. The VERITAS Vision System is safe and effective when used as indicated.Keywords: VERITAS Vision System, cataract, ergonomics, fluidics, satisfaction

Jerry G Hu,1 Vin T Dang,2 Daniel H Chang,2 Damien F Goldberg,3 Cheryl McKinnon,4 Katherine Makedonsky,4 Michal Laron,4 Leilei Ji5 1Texas Eye & Laser Center, P.A., Hurst, TX, USA; 2Empire Eye and Laser Center, Bakersfield, CA, USA; 3Wolstan & Goldberg Eye Associates, Torrance, CA, USA; 4Johnson & Johnson Surgical Vision, Inc., Milpitas, CA, USA; 5Johnson & Johnson Surgical Vision, Inc., Irvine, CA, USACorrespondence: Cheryl McKinnon, Johnson & Johnson Surgical Vision, Inc., 510 Cottonwood Drive, Milpitas, CA, 95035, USA, Tel +1 408 273 4014, Email cmckinno@its.jnj.comPurpose: Investigator feedback was used to assess the clinical use of the LipiFlow® System with the new translucent Activator Clear to successfully complete LipiFlow® treatments.Patients and Methods: This was a prospective, open-label clinical investigation. A total of 88 eyes (44 subjects) were treated using the LipiFlow® System with the new Activator Clear. Subjects diagnosed with bilateral meibomian gland dysfunction (MGD) were enrolled in the study. Each investigator performed a complete LipiFlow® treatment with the translucent Activator on both eyes of each subject. Investigators completed a questionnaire assessing the clinical use of the Activator Clear on a 5-point scale (1 – very difficult or strongly disagree, 3 – neutral, 5 – very easy or strongly agree).Results: The new translucent Activator provided successful LipiFlow® treatments in 100% of cases, with 95% confidence interval of (96%, 100%). Additionally, the investigators agreed or strongly agreed that the translucent components of the Activator Clear made it easy to access and position the activator with confidence on the subject’s eye.Conclusion: The overall investigators’ impressions on usage and functionality of LipiFlow® System with the translucent Activator were very positive. The Activator Clear enables doctors with efficient and confident positioning around patient eyelids to ensure successful LipiFlow® treatment when used as indicated.Keywords: LipiFlow® vectored thermal pulsation, Activator Clear

Daniel H Chang,1 George O Waring 4th,2 Milton Hom,3 Melissa Barnett4 1Empire Eye and Laser Center, Bakersfield, CA, USA; 2Waring Vision Institute, Mt. Pleasant, SC, USA; 3Canyon City Eyecare, Azusa, CA, USA; 4University of California, Davis Eye Center, Sacramento, CA, USACorrespondence: Daniel H ChangEmpire Eye and Laser Center, 4105 Empire Drive, Bakersfield, CA, 93309, USAEmail dchang@empireeyeandlaser.comAbstract: Presbyopia, a loss of accommodative ability associated with aging, is a significant cause of vision impairment globally. At the clinical level, it is a frustrating and difficult issue that negatively impacts patients’ quality of life. Less appreciated is the fact that loss of accommodative ability and its current treatments methods may present safety concerns, for example, increasing the risk of falls. Therefore, a more complete understanding of treatment options with respect to how they relate to the natural ability of the eye is needed to improve decision making and to aid clinicians in individualizing treatment options. This article reviews the options for expanding functional through focus—a term coined to describe the ability of the eye to see at all distances with minimal latency—by how they vary the refractive power over time, across the visual field, between eyes, or across a range of distances.Keywords: accommodation, presbyopia, functional through focus

Thorsten Lichtenstein,1 Kamal Mammadov,2 Karin Rau,1 Nils Große Hokamp,1 Thuy D Do,3 David Maintz,1 De-Hua Chang1,3 1Department of Radiology, University Hospital of Cologne, Cologne, Germany; 2Department of Radiology, Klinikum Aschaffenburg, Aschaffenburg, Germany; 3Department of Diagnostic and Interventional Radiology, University Medical Center Heidelberg, Heidelberg, GermanyCorrespondence: Thorsten LichtensteinInstitut für Diagnostische und Interventionelle Radiologie, Universitätsklinikum Köln (AöR), Kerpener Str. 62, Cologne 50937, GermanyTel +49 221 478-82035Email thorsten.lichtenstein@uk-koeln.dePurpose: This retrospective study examined the incidence, progression, and clinical relevance of catheter-related thrombosis (CRT) and/or fibrin sheaths presenting as incidental findings on routine staging computed tomography (CT) scans performed in cancer patients.Patients and Methods: Patients who underwent central venous port catheter (CVC) placement in a tertiary care hospital between September 2010 and August 2013 were followed up for up to five years. Two radiologists assessed the presence of fibrin sheath and thrombosis in consensus in staging CT scan. Patient demographics, type of cancer, preoperative comorbidities, date of CVC placement and CTs, preexisting anticoagulation, as well as the type and treatment of catheter-related complications were determined from the electronic medical record.Results: A total of 194 patients with 530 CT scans and a mean follow-up time of 394 days were included. Fibrin sheaths and thromboses were seen on 46 scans (8.7%) in 30 patients and 80 scans (15.1%) in 35 patients. The incidence of fibrin sheaths and thromboses was found to be 15.5% and 18%, respectively. The comparison to initial CT reports results indicated that fibrin sheaths or thromboses were missed in 106 examinations (20%). Catheter-associated complications were reported in 14 patients (21.5%) without specific therapy.Conclusion: Fibrin sheaths and CRTs are often overlooked on routine CT scans when patients are asymptomatic. The subsequent high complication rate demonstrates the clinical relevance of the initial incidental finding on CT scan. Further studies should elucidate the effect of thrombolytic agents and interventional radiologic treatment in asymptomatic patients.Keywords: catheter-related complications, central venous catheters, port-a-cath, imaging, staging

De-Hua Chang,1 Karin Slebocki,2 Ekaterina Khristenko,1 Jan Herden,3 Johannes Salem,3 Nils Große Hokamp,2 Kamal Mammadov,2 Martin Hellmich,4 Christoph Kabbasch21Department of Diagnostic and Interventional Radiology, University Medical Center Heidelberg, Heidelberg, Germany; 2Department of Diagnostic and Interventional Radiology, University Hospital of Cologne, Cologne, Germany; 3Department of Urology, University Hospital of Cologne, Cologne, Germany; 4Institute of Medical Statistics and Computational Biology (IMSB), Medical Faculty, University of Cologne, Cologne, GermanyPurpose: Retrospective evaluation and comparison of image quality generated by low-dose computed tomography (LDCT) from obese patients with urolithiasis using alternative reconstruction algorithms.Materials and methods: Twenty-five obese patients (body mass index [BMI]>25 kg/m2,) underwent LDCT scans for suspected urolithiasis. The scans were recompiled using filtered-back projection (FBP), statistical iterative reconstruction (iDose) and iterative model-based reconstruction (IMR). Dose-length product (DLP) and patient details were obtained from the CT dose report and clinical charts, respectively. Objective image noise was assessed by measuring the SD of Hounsfield units (HUs) in defined locations. Additionally, subjective image evaluation was independently performed by two radiologists using a 3-point Likert scale. The inter-reviewer agreement of image quality was calculated.Results: Ureteral concretions were observed in all CT scans, two of which revealed bilateral stones. The assessed patients’ mean BMI was 29.29±3.74 kg/m,2 and the DLP of the CT scans was 100.04±10.00 mGy*cm. All scans were rated diagnostic with the iDose and iterative model-based reconstructions, whereas 41% of the scans performed with FBP reconstruction were nondiagnostic. With respect to image quality, IMR was superior to iDose and FBP, both in the objective (P

Tilman Hickethier,1,* Kamal Mammadov,1,* Bettina Baeßler,1 Thorsten Lichtenstein,1 Jochen Hinkelbein,2 Lucy Smith,3 Patrick Sven Plum,4 Seung-Hun Chon,4 David Maintz,1 De-Hua Chang1 1Department of Radiology, University Hospital of Cologne, Cologne, Germany; 2Department of Anesthesiology and Intensive Care Medicine, University Hospital of Cologne, Cologne, Germany; 3Faculty of Medicine, Memorial University of Newfoundland, St. John’s, Canada; 4Department of General, Visceral and Cancer Surgery, University Hospital of Cologne, Cologne, Germany *These authors contributed equally to this work Background: The study was conducted to compare examination time and artifact vulnerability of whole-body computed tomographies (wbCTs) for trauma patients using conventional or optimized patient positioning. Patients and methods: Examination time was measured in 100 patients scanned with conventional protocol (Group A: arms positioned alongside the body for head and neck imaging and over the head for trunk imaging) and 100 patients scanned with optimized protocol (Group B: arms flexed on a chest pillow without repositioning). Additionally, influence of two different scanning protocols on image quality in the most relevant body regions was assessed by two blinded readers. Results: Total wbCT duration was about 35% or 3:46 min shorter in B than in A. Artifacts in aorta (27 vs 6%), liver (40 vs 8%) and spleen (27 vs 5%) occurred significantly more often in B than in A. No incident of non-diagnostic image quality was reported, and no significant differences for lungs and spine were found. Conclusion: An optimized wbCT positioning protocol for trauma patients allows a significant reduction of examination time while still maintaining diagnostic image quality. Keywords: CT scan, polytrauma, acute care, time requirement, positioning

De-Hua Chang,1,* Sebastian Brinkmann,2,* Lucy Smith,3 Ingrid Becker,4 Wolfgang Schroeder,2 Arnulf H Hoelscher,5 Stefan Haneder,1 David Maintz,1 Judith Eva Spiro6 1Department of Radiology, University Hospital of Cologne, Cologne, Germany; 2Department of General, Visceral and Cancer Surgery, University Hospital of Cologne, Cologne, Germany; 3Faculty of Medicine, Memorial University of Newfoundland, St John’s, Canada; 4Institute of Medical Statistics and Computational Biology, University of Cologne, Cologne, Germany; 5Agaplesion Markus Hospital, Frankfurt am Main, Germany; 6Department of Radiology, University Hospital, LMU Munich, Munich, Germany *These authors contributed equally to this work Purpose: Anastomotic leakage is a major surgical complication following esophagectomy and gastric pull-up. Specific risk factors such as celiac trunk (TC) stenosis and high calcification score of the aorta have been identified, but no data are available on their relative prognostic values. This retrospective study aimed to compare and evaluate calcification score versus stenosis quantification with regards to prognostic impact on anastomotic leakage.Patients and methods: Preoperative contrast-enhanced computed tomography scans of 164 consecutive patients with primary esophageal cancer were evaluated by two radiologists to apply a calcification score (0–3 scale) assessing the aorta, the celiac axis and the right and left postceliac arteries. Concurrently, the presence and degree of stenosis of TC and superior mesenteric artery were recorded for stenosis quantification.Results: Anastomotic leakage was noted in 14/164 patients and 12/14 showed stenosis of TC (n=11). The presence of TC stenosis was found to have a significant impact on anastomotic healing (p=0.004). The odds ratio for the prediction of anastomotic leakage by the degree of stenosis was 1.04 (95% CI, 1.02–1.07). Ten of 14 patients had aortic calcification scores of 1 or 2, but calcification scores of the aorta, the celiac axis and the right and left postceliac arteries did not correlate with the corresponding TC stenosis values and showed no influence on patient outcome as defined by the occurrence of anastomotic insufficiency (p=0.565, 0.855, 0.518 and 1.000, respectively). Inter-reader reliability of computed tomography analysis and absolute agreement on calcium scoring was mostly over 90%. No significant differences in preoperative comorbidities and patient characteristics were found between those with and without anastomotic leakage.Conclusion: Measurement of TC stenosis in preoperative contrast-enhanced computed tomography scans proved to be more reliable than calcification scores in predicting anastomotic leakage and should, therefore, be used in the risk assessment of patients undergoing esophagectomy and gastric pull-up. Keywords: TC stenosis, calcification score, anastomotic leakage, stenosis quantification, Ivor Lewis esophagectomy, graft perfusion

De-Hua Chang,1 Kamal Mammadov,1 Tilman Hickethier,1 Jan Borggrefe,1 Martin Hellmich,2 David Maintz,1 Christoph Kabbasch1 1Department of Diagnostic and Interventional Radiology, University Hospital of Cologne, NRW, Germany; 2Institute of Medical Statistics, Informatics and Epidemiology, University Hospital of Cologne, NRW, Germany Purpose: Evaluation of the efficacy of single-shot, low-dose urokinase administration for the treatment of port catheter-associated fibrin sheaths. Methods: Forty-six patients were retrospectively evaluated for 54 episodes of port catheter dysfunction. The presence of a fibrin sheath was detected by angiographic contrast examinations. On an outpatient basis, patients subsequently received thrombolysis consisting of a single injection of urokinase (15.000 IU in 1.5 mL normal saline) through the port system. A second attempt was made in cases of treatment failure. Patients were followed up for technical success, complications and long-term outcome. Results: Port dysfunction occurred at a median of 117 days after implantation (range: 7–825 days). The technical success after first port dysfunction by thrombolysis was 87% (40/46); thereof, initial thrombolysis was effective in 78% (36/46). Nine patients (20%) received a second dose of urokinase after previous treatment failure. Follow-up was available for 26 of 40 patients after successful thrombolysis. In 8 of these, rethrombosis occurred after a median of 98 days (range: 21–354 days), whereby rethrombolysis was effective in 5 of 7 (63%) patients. The overall success of all thrombolyses performed was 70% (45/64). No procedure-related technical or clinical complications occurred. After first favorable thrombolysis, a Kaplan–Meier analysis yielded a 30-, 90- and 180-day probability of patency of 96%, 87% and 81%. Conclusion: Thrombolytic therapy on an outpatient basis appears to be a safe and efficient. Three-month patency rates are comparable to more invasive treatment options, including catheter exchange over a guide wire and percutaneous fibrin sheath stripping. Keywords: central venous port catheter, thrombolysis, urokinase, angiography, port dysfunction, catheter occlusion

Daniel H Chang Empire Eye and Laser Center, Bakersfield, CA, USA Purpose: The aim of the study is to evaluate the visual acuity and patient satisfaction at varied distances under photopic and mesopic lighting conditions in patients bilaterally implanted with aspheric diffractive multifocal one-piece intraocular lenses. Methods: In this retrospective–prospective study, 16 patients with a mean age of 66.2±9.2 years (range: 50–81 years) who had undergone bilateral phacoemulsification surgery with implantation of a Tecnis multifocal one-piece intraocular lens (ZMB00) were evaluated. Monocular and binocular uncorrected and distance-corrected visual acuities were measured at distance (20 ft), intermediate (70–80 cm), and near (35–40 cm) under photopic (85 cd/m2) and mesopic (3 cd/m2) lighting conditions and were compared using the paired t-test. All patients also completed a subjective questionnaire. Results: At a mean follow-up of 9.5±3.9 months, distance, near, and intermediate visual acuity improved significantly from preoperative acuity. Under photopic and mesopic conditions, 93.8% and 62.5% of patients, respectively, had binocular uncorrected intermediate visual acuity of 20/40 or better, and 62.5% and 31.3% of patients had binocular uncorrected near visual acuity of 20/20 or better. All patients were satisfied with their overall vision without using glasses and/or contact lenses when compared with before surgery. A total of 87.5% of patients reported no glare and 68.8% of patients reported no halos around lights at night. Conclusion: Tecnis multifocal one-piece intraocular lenses provide good distance, intermediate, and near visual acuity under photopic as well as mesopic lighting conditions. High levels of spectacle independence with low levels of photic phenomenon were achieved, resulting in excellent patient satisfaction. Keywords: Tecnis multifocal one-piece IOL, photopic visual acuity, mesopic visual acuity, intermediate visual acuity, near visual acuity

De-Hua Chang,1 Sonja Hiss,1 Lena Herich,2 Ingrid Becker,2 Kamal Mammadov,1 Mareike Franke,1 Anastasios Mpotsaris,1 Robert Kleinert,3 Thorsten Persigehl,1 David Maintz,1 Christopher Bangard1 1Department of Radiology, 2Institute of Medical Statistics, Informatics and Epidemiology, 3Department of Surgery, University Hospital of Cologne, Cologne, Germany Objective: The aim of the study reported here was to evaluate patients’ satisfaction with implantation of venous access devices under local anesthesia (LA) with and without additional oral sedation.Materials and methods: A total of 77 patients were enrolled in the prospective descriptive study over a period of 6 months. Subcutaneous implantable venous access devices through the subclavian vein were routinely implanted under LA. Patients were offered an additional oral sedative (lorazepam) before each procedure. The level of anxiety/tension, the intensity of pain, and patients’ satisfaction were evaluated before and immediately after the procedure using a visual analog scale (ranging from 0 to 10) with a standardized questionnaire.Results: Patients’ satisfaction with the procedure was high (mean: 1.3±2.0) with no significant difference between the group with premedication and the group with LA alone (P=0.54). However, seven out of 30 patients (23.3%) in the group that received premedication would not undergo the same procedure without general anesthesia. There was no significant influence of lorazepam on the intensity of pain (P=0.88). In 12 out of 30 patients (40%) in the premedication group, the level of tension was higher than 5 on the visual analog scale during the procedure. In 21 out of 77 patients (27.3%), the estimate of the level of tension differed between the interventionist and the patient by 3 or more points in 21 out of 77 patients (27.3%).Conclusion: Overall patient satisfaction is high for implantation of venous access devices under LA. A combination of LA with lorazepam administered orally might not be adequate for patients with a high level of anxiety and tension. The level of tension is often underestimated by the interventionist. Pre-procedural standardized questionnaires could be used to identify patients for whom a gradual approach of individualized sedation may be more effective. Keywords: patient satisfaction, pain, supportive care, chemotherapy, central venous port implantation

Objectives: This study aimed to assess the efficacy and safety of monoclonal antibody therapies (MATs) for interstitial cystitis/bladder pain syndrome (IC/BPS)., Methods: A systematic search was conducted across databases including PubMed, Embase, clinicalTrial.gov, and the Cochrane Library Central Register of Controlled Trials. Randomized controlled trials (RCTs) comparing MATs versus placebo were included. Primary outcomes comprised the Global Response Assessment (GRA) scale and the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI). Additional analyses encompassed mean daily frequency of voids, the O'Leary-Sant Interstitial Cystitis Problem Index, pain scores, and complications. Statistical analyses were performed using Review Manager 5.3., Results: Five high-quality RCTs, comprising 263 patients with IC/BPS, were ultimately selected. MATs were generally effective in treating IC/BPS. Patients receiving MATs exhibited a higher satisfaction rate (odds ratio [OR]: 2.7, confidence interval [CI]: 1.31-5.58, p = 0.007) and lower ICSI scores (mean difference [MD]: -1.44, CI: -2.36 to -0.52, p = 0.002). Moreover, MAT recipients experienced reduced pain (MD: -0.53, CI: -0.79 to -0.26, p < 0.0001) and decreased frequency of urination (MD: -1.91, CI: -2.55 to -1.27, p < 0.00001). Importantly, there were no disparities regarding complication incidence in the MAT and control groups., Conclusions: The current findings indicate that MATs are effective and safe for treating IC/BPS. Nonetheless, future RCTs with larger sample sizes and long-term follow-up are warranted., (© 2024 Wiley Periodicals LLC.)

Introduction: This study is a prospective, randomized, subject/evaluator-masked clinical trial in a single-center clinical setting. The purpose of the study is to compare the clinical performance of Tecnis Symfony Optiblue IOL (models ZXR00V and ZXW150) with violet light filter (VLF) and manufacturing improvements versus Tecnis Symfony IOL (models ZXR00 and ZXT150) with ultraviolet light filter (UVF) in patients undergoing cataract surgery., Methods: Patients with cataracts aged ≥ 22 years were randomly assigned 1:1 to bilateral implantation with ZXR00V/ZXW150 (VLF group) or ZXR00/ZXT150 (UVF group). Key endpoints at 6 months postoperative included patient reported nighttime dysphotopsia symptoms, 25% low contrast visual acuity with glare, and patient satisfaction., Results: Sixty patients were implanted with ZXR00V/ZXW150 (30) or ZXR00/ZXT150 (30). At 6 months, the VLF group did not show a statistically significant differences in mean monocular photopic uncorrected distance visual acuity (UCDVA), best-corrected distance visual acuity (BCDVA), uncorrected near visual acuity (UCNVA) (40 cm), or distance-corrected near visual acuity (DCNVA) (40 cm) compared to the UVF group. At 1 month, patients in the VLF group reported significantly less difficulty due to halo (p = 0.016) and starburst (p = 0.028) symptoms. By the 6 months, dysphotopsia complaints were no longer significantly different between the groups. Although the VLF group trended toward better low contrast visual acuity and patient satisfaction, statistical significance was not reached., Conclusions: Managing the patients' expectations is key to achieving success. At the 1-month visit the patients who reported dysphotopsia complaints in the VLF group had significantly less difficulty with starbursts and halos as compared to the UVF group. By the 6-month visit, there was no significant difference between the two groups in the difficulty with starbursts and halos., Trial Registration: ClinicalTrials.gov identifier, NCT06567834., (© 2024. The Author(s).)

Background: Microvascular dysfunction after heart transplantation leads to restrictive cardiac allograft physiology (RCP), which is classified as severe coronary allograft vasculopathy (CAV); however, the prognosis of RCP remains unclear. Therefore, in this study, we aimed to elucidate the prognosis of RCP in comparison with that of severe angiographic CAV., Methods: We assessed 116 patients with severe CAV who underwent heart transplantation between 2004 and 2023. RCP was defined as symptomatic heart failure with restrictive hemodynamic values (mean right atrial pressure >12 mm Hg, pulmonary capillary wedge pressure >25 mm Hg, and cardiac index <2.0 liter/min/m 2 ). The primary outcome was death or retransplantation., Results: Of the 116 patients with severe CAV, 42 had RCP (RCP-CAV group) and 74 had severe angiographic CAV without RCP (Angio-CAV group). A significantly shorter time from heart transplantation to diagnosis and lower subsequent percutaneous catheter intervention after diagnosis were seen in the RCP-CAV group than in the Angio-CAV group (both p < 0.001). Freedom from death or retransplantation at 5 years was significantly worse in the RCP-CAV group compared to the Angio-CAV group (18.4% vs 35.4%, p = 0.001). In the Cox proportional hazard model, RCP was independently associated with an increased risk of death or retransplantation (hazard ratio 2.08, 95% confidence intervals 1.26-3.44, p = 0.004)., Conclusions: The prognosis of patients with RCP was significantly worse than that of patients with severe angiographic CAV. The early detection of microvascular dysfunction and retransplantation listing may improve the prognosis of patients with RCP., Competing Interests: Disclosure statement M.T. received a grant for studying overseas from the Japanese Circulation Society and a grant from Fukuda Foundation for Medical Technology, outside the submitted work. J.K.P. received research grants from Pfizer, Alnylam Pharmaceuticals, and Boehringer Ingelheim Pharmaceuticals. A.P.N. received research grants from Alnylam Pharmaceuticals. D.H.C. is a shareholder of Abbott Laboratories, AbbVie Inc., Amarin Corporation, and Repligen Corporation. J.A.K. received research grants from CareDx Inc., CSL-Behring, and Sanofi-Genzyme, and is part of the advisory board for TransMedics Inc. All other authors have no financial relationships to disclose The authors express gratitude to Christine Sumbi and other California Heart Center research team members who enabled this long-term comprehensive study., (Copyright © 2024 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Objective: To compare therapeutic outcomes of predicted proliferative and nonproliferative hepatocellular carcinoma (HCC) after microwave ablation (MWA) using a previously developed imaging-based predictive model, the SMARS score., Methods: This multicenter retrospective study included consecutive 635 patients with unresectable HCC who underwent MWA between August 2013 and September 2020. Patients were stratified into predicted proliferative and nonproliferative phenotypes according to the SMARS score. Overall survival (OS) and recurrence-free survival (RFS) were compared between the predicted proliferative and nonproliferative HCCs before and after propensity score matching (PSM). OS and RFS were also compared between the two groups in subgroups of tumor size smaller than 30 mm and tumor size 30-50 mm., Results: The SMARS score classified 127 and 508 patients into predicted proliferative and nonproliferative HCCs, respectively. The predicted proliferative HCCs exhibited worse RFS but equivalent OS when compared with nonproliferative HCCs before (p < 0.001 for RFS; p = 0.166 for OS) and after (p < 0.001 for RFS; p = 0.456 for OS) matching. Regarding subgroups of tumor size smaller than 30 mm (p = 0.098) and tumor size 30-50 mm (p = 0.680), the OSs were similar between the two groups. However, predicted proliferative HCCs had worse RFS compared to nonproliferative HCCs in the subgroup of tumor size 30-50 mm (p < 0.001), while the RFS did not differ in the subgroup of tumor size smaller than 30 mm (p = 0.141)., Conclusion: Predicted proliferative HCCs have worse RFS than nonproliferative ones after MWA, especially in tumor size larger than 30 mm. However, the phenotype of the tumor may not affect the OS., Critical Relevance Statement: Before performing microwave ablation for hepatocellular carcinoma, the tumor phenotype should be considered because it may affect the therapeutic outcome., Key Points: Proliferative hepatocellular carcinoma (HCC) may be identified using the SMARS score, an imaging-based predictive model. SMARS predicted proliferative HCCs have worse recurrence-free and equivalent overall survival compared to nonproliferative HCC after microwave ablation. Tumor phenotype should be considered before performing microwave ablation., (© 2024. The Author(s).)

Background: After major liver resections, anatomical shifts due to liver parenchymal hypertrophy and organ displacement can happen. The aim of this study was to evaluate the impact of these anatomical changes on the main abdominal arteries (coeliac trunk and superior mesenteric artery) and on patient outcomes., Methods: All patients who underwent major liver resections (between January 2010 and July 2021) and who underwent preoperative and postoperative arterial-phase contrast-enhanced abdominal CT imaging were studied. Observed arterial position changes were classified into three groups: no position changes; class I position changes (vessel displacement with or without kinking with a vessel angle greater than 105°); and class II position changes (kinking less than or equal to 105°). The Mann-Whitney test and the Kruskal-Wallis test were used to compare continuous variables and the chi-squared test and Fisher's exact test were used to compare categorical variables. Univariable and multivariable logistic regression analyses were used to identify the risk factors for morbidity and mortality., Results: A total of 265 patients (149 men and median age of 59 years) were enrolled. Arterial position changes were detected in a total of 145 patients (54.7%) (99 patients (37%) with class I position changes and 46 patients (18%) with class II position changes) and were observed more often after extended resection and right-sided resection (P < 0.001). Major complications were seen in 94 patients (35%) and the rate of mortality was 15% (40 patients died). Post-hepatectomy liver failure (P = 0.030), major complications (P < 0.001), and mortality (P = 0.004) occurred more frequently in patients with class II position changes. In multivariable analysis, arterial position change was an independent risk factor for post-hepatectomy liver failure (OR 2.86 (95% c.i. 1.06 to 7.72); P = 0.038), major complications (OR 2.10 (95% c.i. 1.12 to 3.93); P = 0.020), and mortality (OR 2.39 (95% c.i. 1.03 to 5.56); P = 0.042)., Conclusion: Arterial position changes post-hepatectomy are observed in the majority of patients and are significantly related to postoperative morbidities and mortality., (© The Author(s) 2024. Published by Oxford University Press on behalf of BJS Foundation Ltd.)

Up to 80% of women living with chronic kidney disease (CKD) experience sexual dysfunction, though its link with sexual activity and sexual satisfaction is not well understood. Among older women with CKD treated with hemodialysis, the majority report sexual inactivity, though few describe sexual difficulty and most report high sexual satisfaction. Whether this applies to reproductive-aged females living with CKD is yet unknown. This study aimed to assess the sexual activity, function, and satisfaction of reproductive-aged females living with CKD. Self-identified females aged 18-51 years with CKD were recruited from nephrology clinics in Calgary, Canada. Sexual activity, function, and satisfaction were assessed with a modified version of the Female Sexual Function Index. Fifty-seven participants were recruited (35% CKD without kidney replacement therapy, 44% CKD treated with hemodialysis, 9% CKD treated with peritoneal dialysis, 12% CKD treated with kidney transplant) and nearly half (47%) reported sexual activity. Among sexually active participants, there was a high prevalence of sexual dysfunction (67%) and only 25% of participants reported sexual satisfaction. A strong relationship between sexual function and satisfaction was identified. Reproductive-aged females living with CKD are sexually active, though experience high rates of sexual dysfunction and dissatisfaction. These findings emphasize the importance of recognition and management of sexual dysfunction in this important population.

Background: Secondary lymphoedema (SL) is one of the most common and, at the same time, most significant consequences and complications of modern oncological therapy. Although a thorough patient history and physical examination are sufficient to substantiate a suspicion, it is essential to perform functional imaging of the lymphatic system for a targeted diagnosis and determination of severity. For this purpose, techniques such as MR and ICG lymphography as well as ultra-high-frequency ultrasound examinations have been developed and validated in recent years. The selective use of these techniques has allowed for individualized indications and successful stage-dependent treatment using (super)microsurgical techniques to restore regional lymphatic drainage in the context of intensified conservative therapy., Method: Systematic review of the literature on the diagnosis and treatment of SL with subsequent analysis and classification of the results into evidence levels according to the Oxford Centre for Evidence-Based Medicine and the GRADE Scale., Results: The established and validated diagnosis of SL includes imaging (ICG fluorescence lymphography, MR lymphography and Tc-99 functional lymphoscintigraphy) in case of a clinical suspicion and in high-risk patients. Complex physical decongestion therapy (CPE) is superior to physical therapy or compression alone. (Super)microsurgery of SL allows for a postoperative reduction in the frequency of CPE, a reduction of erysipelas rates, a volume reduction of the lymphomatous extremity and, if carried out prophylactically, a lower incidence of SL. Suction-assited lipectomy can produce long-term, stable reductions in circumference and an improvement in quality of life., Conclusion: Patients with SL benefit from conservative therapy with regular re-evaluation. Patients with a high risk for SL or with clinical deterioration or persistent symptoms under guideline-based conservative therapy can benefit from (super)microsurgical therapy after an individualized functional diagnostic evaluation of the lymphatic system. Excisional dermolipectomies or lympholiposuctions are available and effective for advanced and refractory stages., Competing Interests: Die Autorinnen/Autoren geben an, dass kein Interessenkonflikt besteht., (Thieme. All rights reserved.)

Portal vein arterialization (PVA) is a surgical procedure that plays a crucial role in hepatic vascular salvage when hepatic artery flow restoration remains elusive. Dedicated diagnostic vascular imaging and the timely management of PVA shunts are paramount to preventing complications, such as portal hypertension and thrombosis. Regrettably, a lack of standardized postoperative management protocols for PVA has increased morbidity and mortality rates post-procedure. In response to this challenge, we developed a PVA standard operating procedure (SOP) tailored to the needs of interventional radiologists. This SOP is designed to harmonize postoperative care, fostering scientific comparability across cases. This concise brief report aims to offer radiologists valuable insights into the PVA technique and considerations for post-PVA care and foster effective interdisciplinary collaboration.

Skin and soft tissue reconstruction has long been based on the reconstructive ladder. However, a skin substitute has become popular due to its predictable outcomes, without donor-site morbidity. The biodegradable temporizing matrix (BTM; NovoSorb, PolyNovo Ltd., Port Melbourne, Australia) is a synthetic skin substitute that has recently gained its clinical application. Compared with those of other dermal templates, the clinical efficacy and performance of the BTM are not well established, especially among the Asian population. This study aims to share our experience and strategy of using BTM in various wound conditions. The data of patients who underwent skin and soft tissue reconstruction with BTM at a single institution between January 2022 and December 2023 were reviewed. The patient demographics, wound characteristics, surgical details, secondary procedures, and complications were recorded and analyzed. Postoperative 6-month photographs were collected and independently evaluated by two plastic surgeons and two wound care center nurses using the Manchester Scar Scale (MSS). This study included 37 patients, consisting of 22 males and 15 females with a mean age of 51.8 years (range, 18-86 years old). The wound etiologies included trauma (67.6%), necrotizing soft tissue infection (16.2%), burns (10.8%), toe gangrene (2.7%), and scar excision (2.7%). The average wound area covered by BTM was 50.6 ± 47.6 cm 2 . Among the patients, eight received concomitant flap surgery and BTM implantation, 20 (54.1%) underwent subsequent split-thickness skin grafts (STSG), and 17 had small wounds (mean: 21.6 cm 2 ) healed by secondary intention. Infection was the most common complication, affecting six patients ( n = 6 [16.2%]), five of whom were treated conservatively, and only one required debridement. Thirty-three patients (89.2%) had good BTM take, and only four had BTM failure, requiring further reconstruction. At the last follow-up, 35 out of the 37 patients (94.6%) achieved successful wound closure, and the total MSS score was 10.44 ± 2.94, indicating a satisfactory scar condition. The patients who underwent BTM grafting without STSG had better scar scores than those who received STSG (8.71 ± 2.60 vs. 11.18 ± 2.84, p = 0.039). In conclusion, the BTM is effective and feasible in treating various wounds, with relatively low complication rates, and it can thus be considered as an alternative for skin and soft tissue reconstruction. When combined with adipofasical flap reconstruction, it achieves a more comprehensive anatomical restoration.

Background: V-Y advancement flap (VYAF) is a commonly used flap for facial reconstruction, but it is not popular in Asian society with limited aesthetic outcome evaluation., Objective: To demonstrate our experience of facial VYAF with the quantitative aesthetic outcome assessment., Methods and Materials: From January 2013 to December 2022, patients who underwent facial VYAF reconstruction were reviewed. Postoperative photographs were collected and independently graded by three plastic surgeons, three nurses, and six non-medical personnel using Manchester scar scale (MSS). The representative preoperative images were selected for surgeons' reconstruction preferences survey., Results: Forty-eight patients (27 females and 21 males), with a mean age of 66.8 (23-97) years, were included in this study. All flaps survived with no flap necrosis. Only six patients (12.5%) developed minor postoperative complications, and they were treated conservatively and resolved uneventfully. The total MSS score was 7.8 ± 1.9 (scale of 4 [best scar] to 24 [worst scar]) and the overall scar VAS rating was 1.9 ± 1.1 (0 [best scar] to 10 [worst scar]), indicating satisfactory postoperative scar condition. From the survey of 22 plastic surgeons and 11 scenarios, VYAF was rarely chosen among other local flaps which only accounted for 8.7%., Conclusion: VYAF is an easy and safe method for facial reconstruction with low morbidity, but its usefulness is underappreciated. With a proper design and cautious dissection, we believe that good aesthetic and functional outcomes can be achieved with VYAF., Level of Evidence Iv: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 ., (© 2024. Springer Science+Business Media, LLC, part of Springer Nature and International Society of Aesthetic Plastic Surgery.)

Akkermansia muciniphila has received great attention because of its beneficial roles in gut health by regulating gut immunity, promoting intestinal epithelial development, and improving barrier integrity. However, A. muciniphila-derived functional molecules regulating gut health are not well understood. Microbiome-secreted proteins act as key arbitrators of host-microbiome crosstalk through interactions with host cells in the gut and are important for understanding host-microbiome relationships. Herein, we report the biological function of Amuc&#95;1409, a previously uncharacterised A. muciniphila-secreted protein. Amuc&#95;1409 increased intestinal stem cell (ISC) proliferation and regeneration in ex vivo intestinal organoids and in vivo models of radiation- or chemotherapeutic drug-induced intestinal injury and natural aging with male mice. Mechanistically, Amuc&#95;1409 promoted E-cadherin/β-catenin complex dissociation via interaction with E-cadherin, resulting in the activation of Wnt/β-catenin signaling. Our results demonstrate that Amuc&#95;1409 plays a crucial role in intestinal homeostasis by regulating ISC activity in an E-cadherin-dependent manner and is a promising biomolecule for improving and maintaining gut health., (© 2024. The Author(s).)

Purpose: Evaluation of the influence of intrinsic and extrinsic conditions on ablation zone volumes (AZV) after microwave ablation (MWA)., Methods: Retrospective analysis of 38 MWAs of therapy-naïve liver tumours performed with the NeuWave PR probe. Ablations were performed either in the 'standard mode' (65 W, 10 min) or in the 'surgical mode' (95 W, 1 min, then 65 W, 10 min). AZV measurements were obtained from contrast-enhanced computed tomography immediately post-ablation., Results: AZVs in the 'standard mode' were smaller than predicted by the manufacturer (length 3.6 ± 0.6 cm, 23% below 4.7 cm; width 2.7 ± 0.6, 23% below 3.5 cm). Ablation zone past the tip was limited to 6 mm in 28/32 ablations. Differences in AZV between the 'surgical mode' and 'standard mode' were not significant (15.6 ± 7.8 mL vs. 13.9 ± 8.8 mL, p = 0.6). AZVs were significantly larger in case of hepatocellular carcinomas (HCCs) ( n = 19) compared to metastasis ( n = 19; 17.8 ± 9.9 mL vs. 10.1 ± 5.1 mL, p = 0.01) and in non-perivascular tumour location ( n = 14) compared to perivascular location ( n = 24, 18.7 ± 10.4 mL vs. 11.7 ± 6.1 mL, p = 0.012), with both factors remaining significant in two-way analysis of variance (HCC vs. metastasis: p = 0.02; perivascular vs. non-perivascular tumour location: p = 0.044)., Conclusion: Larger AZVs can be expected in cases of HCCs compared with metastases and in non-perivascular locations. Using the 'surgical mode' does not increase AZV significantly.

Purpose: Patients with advanced prostate cancer (PCa) often develop castration-resistant PCa (CRPC) with poor prognosis. Prognostic information obtained from multiparametric magnetic resonance imaging (mpMRI) and histopathology specimens can be effectively utilized through artificial intelligence (AI) techniques. The objective of this study is to construct an AI-based CRPC progress prediction model by integrating multimodal data., Methods and Materials: Data from 399 patients diagnosed with PCa at three medical centers between January 2018 and January 2021 were collected retrospectively. We delineated regions of interest (ROIs) from 3 MRI sequences viz, T2WI, DWI, and ADC and utilized a cropping tool to extract the largest section of each ROI. We selected representative pathological hematoxylin and eosin (H&E) slides for deep-learning model training. A joint combined model nomogram was constructed. ROC curves and calibration curves were plotted to assess the predictive performance and goodness of fit of the model. We generated decision curve analysis (DCA) curves and Kaplan-Meier (KM) survival curves to evaluate the clinical net benefit of the model and its association with progression-free survival (PFS)., Results: The AUC of the machine learning (ML) model was 0.755. The best deep learning (DL) model for radiomics and pathomics was the ResNet-50 model, with an AUC of 0.768 and 0.752, respectively. The nomogram graph showed that DL model contributed the most, and the AUC for the combined model was 0.86. The calibration curves and DCA indicate that the combined model had a good calibration ability and net clinical benefit. The KM curve indicated that the model integrating multimodal data can guide patient prognosis and management strategies., Conclusion: The integration of multimodal data effectively improves the prediction of risk for the progression of PCa to CRPC., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Zhou, Zhang, Guo, Huang, Qiao, Wang, Zhao, Chang, Zhao, Da and Zhou.)

Background & Aims: Inoperable hepatocellular carcinoma (HCC) can be treated by stereotactic body radiotherapy. However, carbon ion radiotherapy (CIRT) is more effective for sparing non-tumorous liver. High linear energy transfer could promote therapy efficacy. Japanese and Chinese studies on hypofractionated CIRT have yielded excellent results. Because of different radiobiological models and the different etiological spectrum of HCC, applicability of these results to European cohorts and centers remains questionable. The aim of this prospective study was to assess safety and efficacy and to determine the optimal dose of CIRT with active raster scanning based on the local effect model (LEM) I., Methods: CIRT was performed every other day in four fractions with relative biological effectiveness (RBE)-weighted fraction doses of 8.1-10.5 Gy (total doses 32.4-42.0 Gy [RBE]). Dose escalation was performed in five dose levels with at least three patients each. The primary endpoint was acute toxicity after 4 weeks., Results: Twenty patients received CIRT (median age 74.7 years, n = 16 with liver cirrhosis, Child-Pugh scores [CP] A5 [n = 10], A6 [n = 4], B8 [n = 1], and B9 [n = 1]). Median follow up was 23 months. No dose-limiting toxicities and no toxicities exceeding grade II occurred, except one grade III gamma-glutamyltransferase elevation 12 months after CIRT, synchronous to out-of-field hepatic progression. During 12 months after CIRT, no CP elevation occurred. The highest dose level could be applied safely. No local recurrence developed during follow up. The objective response rate was 80%. Median overall survival was 30.8 months (1/2/3 years: 75%/64%/22%). Median progression-free survival was 20.9 months (1/2/3 years: 59%/43%/43%). Intrahepatic progression outside of the CIRT target volume was the most frequent pattern of progression., Conclusions: CIRT of HCC yields excellent local control without dose-limiting toxicity., Impact and Implications: To date, safety and efficacy of carbon ion radiotherapy for hepatocellular carcinoma have only been evaluated prospectively in Japanese and Chinese studies. The optimal dose and fractionation when using the local effect model for radiotherapy planning are unknown. The results are of particular interest for European and American particle therapy centers, but also of relevance for all specialists involved in the treatment and care of patients with hepatocellular carcinoma, as we present the first prospective data on carbon ion radiotherapy in hepatocellular carcinoma outside of Asia. The excellent local control should encourage further use of carbon ion radiotherapy for hepatocellular carcinoma and design of randomized controlled trials., Clinical Trials Registration: The study is registered at ClinicalTrials.gov (NCT01167374)., Competing Interests: PH and JL are funded by the Physician-Scientist Program of Heidelberg University, Faculty of Medicine. PH received fees for an advisory board from NovoCure GmbH. FW received speaker fees from AstraZeneca and Merck Sharp & Dohme. JD received grants from Accuray International Sàrl, Merck Serono GmbH, CRI – The Clinical Research Institute GmbH, View Ray Inc., Accuray Incorporated, RaySearch Laboratories AB, Vision RT limited, Astellas Pharma GmbH, Astra Zeneca GmbH, Solution Akademie GmbH, Ergomed PLC Surrey Research Park, Siemens Healthcare GmbH, Quintiles GmbH, NovoCure, Pharmaceutical Research Associates GmbH, Boehringer Ingelheim Pharma GmbH Co, PTW-Freiburg Dr Pychlau GmbH, Nanobiotix A.A. and IntraOP Medical outside the submitted work. JHR received speaker fees and travel reimbursement from ViewRay Inc., travel reimbursement from IntraOP Medical and Elekta Instrument AB, and a grant from IntraOP Medical outside the submitted work. Please refer to the accompanying ICMJE disclosure forms for further details., (© 2024 The Authors.)

Hyperbaric oxygen therapy (HBOT) has been used as an adjuvant treatment for crush injury because it can improve tissue hypoxia and stimulate wound healing. However, the actual role of HBOT in crush hand injury is still unknown. This study is to assess the efficacy of HBOT for crush hand patients, as well as the impact of HBOT initiation timing. Between 2018 and 2021, 72 patients with crush hand injury were retrospectively reviewed. The patients were divided into the HBOT and control group, and each group had 36 patients. The average session of HBOT was 18.2 (5-32 sessions) per patient, and no patient had a complication related to the treatment. The two groups had similar demographics, but HBOT group had larger injured area (73.6 ± 51.0 vs. 48.2 ± 45.5 cm 2 , p = 0.03). To better control the confounding factors, we performed the subgroup analysis with cut-off injured area of 50 cm 2 . In the patients with smaller injured area (≦50 cm 2 ), the HBOT group had shorter wound healing time (29.9 ± 12.9 vs. 41.0 ± 18.9 days, p = 0.03). The early HBOT group (first session ≤72 h post-operatively) had shorter hospital stay (8.1 ± 6.4 vs. 15.5 ± 11.4 days, p = 0.04), faster wound healing (28.7 ± 17.8 vs. 41.1 ± 18.1 days, p = 0.08) and less operations (1.54 ± 0.78 vs. 2.41 ± 1.62, p = 0.06) although the latter two didn't achieve statistical significance. HBOT is safe and effective in improving wound healing of hand crush injury. Early intervention of HBOT may be more beneficial. Future research is required to provide more evidence., (© 2023 The Wound Healing Society.)

Background: The combination of gemcitabine and cisplatin (gem/cis) with the anti-PD-L1-antibody durvalumab was recently approved as first line therapy for biliary tract cancer (BTC) based on the results of the TOPAZ-1 trial., Objective: We aim to analyse the feasibility and efficacy of the triple combination therapy in patients with BTC in a real-world setting and in correspondence with the genetic alterations of the cancer., Methods: In this single-centre retrospective analysis, all patients with BTC and treated with durvalumab plus gem/cis from April 2022 to September 2023 were included. Survival and treatment response were investigated, within the context of the inclusion and exclusion criteria of TOPAZ-1 and in correspondence with genetic alterations of the cancer., Results: In total, 35 patients, of which 51% met the inclusion criteria of the TOPAZ-1 trial, were analysed. Patients treated within TOPAZ-1 criteria did not have a significantly different median overall survival and progression free survival than the rest of the patients (10.3 versus 9.7 months and 5.3 versus 5 months, respectively). The disease control rate of patients within the TOPAZ-1 criteria was 61.1%, in comparison to 58.8% in the rest of patients. A total of 51 grade 3 and 4 adverse events were observed without significant differences in the subgroups. No specific correlating patterns of genetic alterations with survival and response were observed., Conclusions: The treatment of advanced patients with BTC with durvalumab and gem/cis, even beyond the inclusion criteria of the TOPAZ-1 trial, shows promising safety., (© 2024. The Author(s).)

Aims: The gut microbiota is increasingly recognised as a pivotal regulator of immune system homeostasis and brain health. Recent research has implicated the gut microbiota in age-related cognitive impairment and dementia. Agathobaculum butyriciproducens SR79 T (SR79), which was identified in the human gut, has been reported to be beneficial in addressing cognitive deficits and pathophysiologies in a mouse model of Alzheimer's disease. However, it remains unknown whether SR79 affects age-dependent cognitive impairment., Main Method: To explore the effects of SR79 on cognitive function during ageing, we administered SR79 to aged mice. Ageing-associated behavioural alterations were examined using the open field test (OFT), tail suspension test (TST), novel object recognition test (NORT), Y-maze alternation test (Y-maze), and Morris water maze test (MWM). We investigated the mechanisms of action in the gut and brain using molecular and histological analyses., Key Findings: Administration of SR79 improved age-related cognitive impairment without altering general locomotor activity or depressive behaviour in aged mice. Furthermore, SR79 increased mature dendritic spines in the pyramidal cells of layer III and phosphorylation of CaMKIIα in the cortex of aged mice. Age-related activation of astrocytes in the cortex of layers III-V of the aged brain was reduced following SR79 administration. Additionally, SR79 markedly increased IL-10 production and Foxp3 and Muc2 mRNA expression in the colons of aged mice., Significance: These findings suggest that treatment with SR79 may be a beneficial microbial-based approach for enhancing cognitive function during ageing., Competing Interests: Declaration of competing interest B.C. Kim is a founder of HealthBiome Inc. The other authors declare that they have no competing interests., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: ALPPS popularity is increasing among surgeons worldwide and its indications are expanding to cure patients with primarily unresectable liver tumors. Few reports recommended limitations or even contraindications of ALPPS in perihilar cholangiocarcinoma (phCC). Here, we discuss the results of ALPPS in patients with phCC in a systematic review as well as a pooled data analysis., Methods: MEDLINE and Web of Science databases were systematically searched for relevant literature up to December 2023. All studies reporting ALPPS in the management of phCC were included. A single-arm meta-analysis of proportions was carried out to estimate the overall rate of outcomes., Results: After obtaining 207 articles from the primary search, data of 18 studies containing 112 phCC patients were included in our systematic review. Rates of major morbidity and mortality were calculated to be 43% and 22%, respectively. The meta-analysis revealed a PHLF rate of 23%. One-year disease-free survival was 65% and one-year overall survival was 69%., Conclusions: ALPPS provides a good chance of cure for patients with phCC in comparison to alternative treatment options, but at the expense of debatable morbidity and mortality. With refinement of the surgical technique and better perioperative patient management, the results of ALPPS in patients with phCC were improved.

Significance: With the increasing diabetic population worldwide, diabetic foot ulcers (DFUs) are a significant concern. This study aimed to compare the efficacy of skin substitutes, biomaterials, and topical agents with standard care. Recent Advances: A meta-analysis was conducted using Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. PubMed, EMBASE, and Web of Science were searched using the following keywords: diabetes mellitus AND skin graft OR tissue replacement OR dressing OR drug. Two independent reviewers performed data collection and quality assessment of the eligible studies. The primary outcome was the 12- to 16-week healing rates and the secondary outcome was recurrence rates. Critical Issues: Thirty-eight randomized controlled trials, including 3,862 patients, were analyzed. The studies exhibited low heterogeneity (τ 2  = 0.10) without significant asymmetry (Egger's test, p  = 0.8852). After pooling direct and indirect estimates, placenta-based tissue products exhibited the best wound healing probability ( p -score = 0.90), followed by skin substitutes with living cells ( p -score = 0.70), acellular skin substitutes ( p -score = 0.56), and advanced topical dressings ( p -score = 0.34) compared with standard of care. The recurrence analysis showed significant improvement in the intervention group compared with the control group (11.21% vs. 15.15%). Future Directions: This network meta-analysis provides the relative effectiveness and rank of biomaterials and topical dressings in DFU healing. The results could help clinical decision making.

Background: Hypertension is the most important modifiable cardiovascular risk factor among women. Chronic kidney disease (CKD), which affects 1 in 10 reproductive-aged women, increases the risk of hypertension; however, awareness of hypertension in this population is unknown. This study aimed to determine hypertension awareness among reproductive-aged women living with chronic kidney disease., Methods: Women aged 18 to 50 years with CKD were recruited from nephrology clinics in Calgary, Alberta, Canada. Participants completed a semistructured interview and focused chart review, serum and urine laboratory assessment, and a physical examination that included anthropomorphic measurements and 2 automated office blood pressure readings. Hypertension was defined according to the use of ≥ 1 antihypertensive medications and/or an automated office blood pressure reading of ≥ 135/85 mm Hg. Data were stratified by hypertension status, as well as by awareness, and descriptively presented as mean ± standard deviation, numerical values, and percentages., Results: Sixty-three participants with CKD were included. Thirty-eight (60%) participants had hypertension according to study definitions. Of those with hypertension, 30 participants (79%) were aware of their hypertension status., Conclusions: Hypertension awareness is relatively high in reproductive-aged women living with CKD. However, hypertension awareness is the critical component for hypertension management, and further work is necessary to optimize reduction of cardiovascular risk in this important population., (© 2023 The Authors.)

Antimicrobial peptides (AMPs) are promising candidates to combat pathogens that are resistant to conventional antimicrobial drugs because they operate through mechanisms that involve membrane disruption. However, the use of AMPs in clinical settings has been limited, at least in part, by their susceptibility to proteolytic degradation and their lack of selectivity toward pathogenic microbes vs mammalian cells. We recently reported on the design of α- and β-peptide oligomers structurally templated upon the naturally occurring α-helical AMP aurein 1.2. These α/β-peptide oligomers are more proteolytically stable than aurein 1.2 and have several other attributes that render them attractive as alternatives to conventional AMPs. This study describes the influence of peptide physicochemical properties on the broad-spectrum activity of aurein 1.2-based α/β-peptide mimics against nine bacterial, fungal, and mammalian cell lines. We used a partial least-squares regression (PLSR)-supervised machine learning model to quantify and visualize relationships between experimentally determined physicochemical properties (e.g., hydrophobicity, charge, and helicity) and experimentally measured cell-type-specific activities of 21 peptides in a 149-member α/β-peptide library. Using this approach, we identified several peptides that were predicted to exhibit enhanced broad-spectrum selectivity, a measure that evaluates antimicrobial activity relative to mammalian cell toxicity compared to aurein 1.2. Experimental validation demonstrated high model predictive performance, and characterization of compounds with the highest broad-spectrum selectivity revealed peptide hydrophobicity, helicity, and helical rigidity to be strong predictors of broad-spectrum selectivity. The most selective peptide identified from the model prediction has more than a 13-fold improvement in broad-spectrum selectivity than that of aurein 1.2, demonstrating the ability of using PLSR models to identify quantitative structure-function relationships for nonstandard amino acid-containing peptides. Overall, this work establishes quantifiable guidelines for the rational design of helical antimicrobial α/β-peptides and identifies promising new α/β-peptides with significantly reduced mammalian toxicities and improved antifungal and antibacterial activities relative to aurein 1.2.