Multimodal Imaging Reveals Improvement of Blood Supply to an Artificial Cell Transplant Site Induced by Bioluminescent Mesenchymal Stem Cells

Purpose

An artificial site for cell or pancreatic islet transplantation can be created using a polymeric scaffold, even though it suffers subcutaneously from improper vascularisation. A sufficient blood supply is crucial for graft survival and function and can be enhanced by transplantation of mesenchymal stem cells (MSCs). The purpose of this study was to assess the effect of syngeneic MSCs on neoangiogenesis and cell engraftment in an artificial site by multimodal imaging.

Procedures

MSCs expressing a gene for luciferase were injected into the artificial subcutaneous site 7 days after scaffold implantation. MRI experiments (anatomical and dynamic contrast-enhanced images) were performed on a 4.7-T scanner using gradient echo sequences. Bioluminescent images were acquired on an IVIS Lumina optical imager. Longitudinal examination was performed for 2 months, and one animal was monitored for 16 months.

Results

We confirmed the long-term presence (lasting more than 16 months) of viable donor cells inside the scaffolds using bioluminescence imaging with an optical signal peak appearing on day 3 after MSC implantation. When compared to controls, the tissue perfusion and vessel permeability in the scaffolds were significantly improved at the site with MSCs with a maximal peak on day 9 after MSC transplantation.

Conclusions

Our data suggest that the maximal signal obtained by bioluminescence and magnetic resonance imaging from an artificially created site between 3 and 9 days after MSC transplantation can predict the optimal time range for subsequent cellular or tissue transplantation, including pancreatic islets.

     

In Vivo HER2-Targeted Magnetic Resonance Tumor Imaging Using Iron Oxide Nanoparticles Conjugated with Anti-HER2 Fragment Antibody

Purpose

The feasibility of iron oxide nanoparticles (IONPs) conjugated with anti-epidermal growth factor receptor 2 (HER2) single-chain antibody (scFv-IONPs) as novel HER2-targeted magnetic resonance (MR) contrast agents was investigated.

Procedures

The scFv-IONPs were prepared and identified. For in vitro MRI, NCI-N87 (HER2 high expression) and SUIT2 (low expression) cells were incubated with scFv-IONPs. For in vivo MRI, NCI-N87 and SUIT2 tumor-bearing mice were intravenously injected with scFv-IONPs and imaged before and 24 h post-injection.

Results

The scFv-IONPs demonstrated high transverse relaxivity (296.3 s^?1 mM^?1) and affinity toward HER2 (K_D?=?11.7 nM). In the in vitro MRI, NCI-N87 cells treated with scFv-IONPs exhibited significant MR signal reduction (44.6 %) than SUIT2 cells (6.8 %). In the in vivo MRI, decrease of MR signals in NCI-N87 tumors (19.3 %) was more notable than that in SUIT2 tumors (6.2 %).

Conclusions

The scFv-IONPs enabled HER2-specific tumor MR imaging, suggesting the potential of scFv-IONPs as a robust HER2-targeted MR contrast agent.

     

Mesalazine Modified-Release Tablet in the Treatment of Ulcerative Colitis in the Active Phase: A Chinese,Multicenter, Single-Blind,Randomized Controlled Study

Introduction

This study compared the efficacy and safety of two mesalazine formulations in the treatment of Chinese patients with mildly to moderately active ulcerative colitis (UC).

Methods

In this multicenter, single-blind, randomized controlled study of 251 patients with active UC conducted from November 2010 to January 2012, subjects were randomized to treatment with mesalazine modified-release tablets (MR group, n = 123) or enteric-coated tablets (EC group, n = 128) at 800 mg three-times daily for 8 weeks. The primary efficacy measure was the decrease in UC Disease Activity Index (UCDAI) at final evaluation. If the 95% confidence interval (CI) lower limit of the difference of the decrease in UCDAI between groups was over ?1.0, mesalazine modified-release tablets were considered non-inferior to mesalazine enteric-coated tablets. The change in UCDAI in patients with mild and moderate (UCDAI 3–5 and 6–8 at enrollment, respectively) UC was analyzed. Secondary efficacy measures were remission and efficacy rates. Incidences of adverse drug reactions (ADRs) were calculated.

Results

The decreases in UCDAI at final evaluation were 2.84 and 2.56 in the MR and EC groups, respectively, with a difference of 0.27 between groups (95% CI ?0.34, 0.88). The remission rates were 48.33% (58/120) and 55.65% (69/124), and the efficacy rates were 63.33% (76/120) and 66.94% (83/124) in the MR and EC groups, respectively (all P > 0.05). In patients with mild UC, the decreases in UCDAI were 2.16 and 2.05 in the MR and EC groups, respectively, while in patients with moderate UC they were 3.49 and 3.03, respectively (all P > 0.05). The incidences of ADRs in the MR and EC groups were 6.61% (8/121) and 10.24% (13/127), respectively (P > 0.05). No serious ADRs were reported during the study.

Conclusion

Mesalazine modified-release tablets are non-inferior to enteric-coated tablets and are an effective and safe treatment option in Chinese patients with mildly to moderately active UC.

Trial registration

ClinicalTrials.gov identifier: NCT01257386.

Funding

Tillotts Pharma AG.

     

Mesalazine Modified-Release Tablet in the Treatment of Ulcerative Colitis in the Remission Phase: A Chinese,Multicenter, Single-Blind,Randomized Controlled Study

Introduction

This study aimed to compare the efficacy and safety of two mesalazine formulations in the treatment of Chinese patients with ulcerative colitis (UC) in the remission phase.

Methods

In this multicenter, single-blind, randomized controlled study conducted from November 2010 to August 2012, 251 patients with UC from 18 hospitals were enrolled. The patients were randomized to treatment with mesalazine modified-release tablets (MR group, n = 126) or other enteric-coated tablets (EC group, n = 125), at 800 mg three-times daily for 48 weeks. The primary efficacy parameter was the rate of non-emergence of bloody stool. If the lower limit of the 95% confidence interval (CI) of the primary efficacy measure was over ?10%, the modified-release tablets were considered non-inferior to the enteric-coated tablets. The secondary efficacy parameters included the period of non-emergence of bloody stool and the period of non-recurrence of UC. The incidences of adverse events and adverse drug reactions were compared between the two groups.

Results

At 48 weeks of maintenance treatment, the rates of non-emergence of bloody stool were 82.99% (95% CI 73.53–92.45%) and 73.30% (95% CI 64.04–82.56%) in the MR and EC groups, respectively, and the difference between the two groups was 9.69% (95% CI ?1.15–20.53%). There was no significant difference in the period of non-emergence of bloody stool and the period of non-recurrence of UC between the two groups (P > 0.05). The incidences of adverse events were 48.78% (60/123) and 48.00% (60/125) in the MR and EC groups, respectively (P = 0.902). The incidences of adverse drug reactions were 16.26% (20/123) and 13.60% (17/125) in the MR and EC groups, respectively (P = 0.556).

Conclusion

Mesalazine modified-release tablets were non-inferior to the enteric-coated tablets and may be considered an effective and safe treatment alternative for the maintenance of remission in Chinese patients with UC.

Trial registration

ClinicalTrials.gov identifier: NCT01257399.

Funding

Tillotts Pharma AG.

     

Prone equals prone? Impact of positioning techniques on respiratory function in anesthetized and paralyzed healthy children

Objectives

Although the prone position is effectively used to improve oxygenation, its impact on functional residual capacity is controversial. Different techniques of body positioning might be an important confounding factor. The aim of this study was to determine the impact of two different prone positioning techniques on functional residual capacity and ventilation distribution in anesthetized, preschool-aged children.

Design

Functional residual capacity and lung clearance index, a measure of ventilation homogeneity, were calculated using a sulfur-hexafluoride multibreath washout technique. After intubation, measurements were taken in the supine position and, in random order, in the flat prone position and the augmented prone position (gel pads supporting the pelvis and the upper thorax).

Setting

Pediatric anesthesia unit of university hospital.

Patients and participants

Thirty preschool children without cardiopulmonary disease undergoing elective surgery.

Measurements and results

Mean (range) age was 48.5 (24–80) months, weight 17.2 (10.5–26.9)?kg, functional residual capacity (mean ±?SD) 22.9?±?6.2?ml.kg ^?1 in the supine position and 23.3?±?5.6?ml.kg ^?1 in the flat prone position, while lung clearance indices were 8.1?±?2.3 vs. 7.9?±?2.3, respectively. In contrast, functional residual capacity increased to 27.6 ± 6.5 ml.kg ^?1 (pp

Conclusions

Functional residual capacity and ventilation distribution were similar in the supine and flat prone positions, while these parameters improved significantly in the augmented prone position, suggesting that the technique of prone positioning has major implications for pulmonary function.

     

Clinical application of navigator-gated three-dimensional balanced turbo-field-echo magnetic resonance cholangiopancreatography at 3 T: prospective intraindividual comparison with 1.5 T

Objective

To evaluate and compare the clinical utility of balanced turbo-field-echo (BTFE) magnetic resonance cholangiopancreatography (MRCP) sequences obtained at 3 and 1.5 T.

Methods

We acquired three-dimensional (3D) BTFE MRCP scans with a navigator-gated technique at 3 T on a different day after 1.5 T in 39 consecutive patients. Two radiologists independently rated the image quality and visibility of anatomical structures (right and left hepatic duct, cystic duct, gallbladder, common bile duct, and main pancreatic duct) using a four-point scale. For quantitative analysis, the signal-to-noise ratio (SNR), contrast-to-noise ratio (CNR), and acquisition time were evaluated.

Results

All visual scores tended to be higher for 1.5 T than 3 T images. There was a significant difference in the image quality and the depiction of the main pancreatic duct (p < 0.01). The image acquisition time was significantly shorter for 3 T than 1.5 T (199.3 ± 40.1 vs. 264.0 ± 86.5 s, p < 0.01). There was no significant difference in SNR and CNR.

Conclusions

3D-BTFE MRCP scans acquired at 3 T were of sufficient image quality with respect to the biliary tree. SNR and CNR were comparable on 3 and 1.5 T scans, although the acquisition time was significantly shorter with the 3 T scanner.

     

Measurement of pancreatic cystic lesions on magnetic resonance imaging: efficacy of standards in reducing inter-observer variability

Purpose

The purpose of this study is to assess inter-observer variability in the measurement of pancreatic cystic lesions with MRI and to determine the impact of measurement standards.

Materials and methods

In this IRB-approved, HIPAA-compliant study with waiver of informed consent, 144 MRI examinations, containing pancreatic cystic lesions measuring between 5 and 35 mm, were reviewed independently by two radiology attendings and two abdominal imaging fellows. Measurements were repeated by the same reviewers 12 weeks later after the introduction of measurement standards. Results were analyzed using within-subject standard deviation, intraclass correlation coefficient, and kappa.

Results

Prior to standardization, the within-subject standard deviation, showing measurement variability in each cyst, was 4.0 mm, which was reduced to 3.3 mm after introduction of measurement standards (p < 0.01). Overall inter-observer agreement, kappa, improved from 0.59 to 0.65 (p = 0.04). The frequency of all four reviewers agreeing on size category increased from 51% to 60%. The intraclass correlation coefficient increased from 0.81 to 0.86.

Conclusions

There is significant and frequent inter-observer variability in the measurement of pancreatic cystic lesions with MRI which could affect clinical management. Implementation of measurement standards reduces measurement variability and aids in preventing erroneous reporting of growth and potentially unwarranted changes in management.

     

Pooled Aquablation Results for American Men with Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia in Large Prostates (60–150 cc)

Introduction

To present short-term safety and efficacy data of men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) treated with Aquablation.

Methods

Men with LUTs secondary to BPH (60–150 cc) underwent Aquablation treatment from February 2016 to December 2017 across 17 investigational sites in the USA from two contemporary investigational device exemption (IDE) studies called WATER (NCT02505919) and WATER II (NCT03123250).

Results

One hundred seven males with mean age of 67.3?±?6.5 years were treated with Aquablation; mean prostate volume was 99.4?±?24.1 cc. The pooled results show that large prostates have an average procedure time of less than 36 min and discharge on average 1.6?±?1 days. The IPSS decreased by 16.7?±?8.1 points at 3 months and Q_max increased by 11.2?±?12.4 ml/s. The Clavien-Dindo (CD) grade 2 or higher event rate at 3 months was 29%. A non-hierarchical breakdown for CD events yielded 18% grade 2 and 19% grade 3 or higher.

Conclusion

Men with LUTS secondary to BPH (60–150 cc) in a pooled analysis were treated safely and effectively with Aquablation up to 3 months postoperatively.

Trial Registration

ClinicalTrials.gov identifiers, NCT02505919 and NCT03123250.

Funding

PROCEPT BioRobotics.

     

Fully automatic cross-modality localization and labeling of vertebral bodies and intervertebral discs in 3D spinal images

Purpose

We present a cross-modality and fully automatic pipeline for labeling of intervertebral discs and vertebrae in volumetric data of the lumbar and thoracolumbar spine. The main goal is to provide an algorithm that is applicable to a wide range of different sequences and acquisition protocols, like T1- and T2- weighted MR scans, MR Dixon data, and CT scans. This requires that the learned models generalize without retraining to modalities and scans with unseen image contrasts.

Methods

We address this challenge by automatically localizing the sacral region combining local entropy-optimized texture models with convolutional neural networks. For subsequent labeling, local three-disc entropy models are matched iteratively to the spinal column. Every model-matched position is further refined by an intensity-based template-matching approach, based solely on the reduced intensity scale provided by the entropy models.

Results

We evaluated our method on 161 publicly available scans, acquired on various scanners. We showed that our method can deal with a wide range of different MR protocols as well as with CT data. We achieved a sacrum detection rate of 93.6%. Mean center accuracies ranged from 2.5 ± 1.5 to 5.7 ± 3.8 mm for the different sets of scans.

Conclusion

We present a novel spine labeling framework that is applicable to a highly heterogeneous set of scans without retraining of the method. Our approach achieves high sacrum localization accuracy and shows promising labeling results. To the best of our knowledge, an algorithm able to deal with such a diverse set of MR and CT scans has not yet been presented in the literature.

     

Feasibility of Using an Enzymatically Activatable Fluorescence Probe for the Rapid Evaluation of Pancreatic Tissue Obtained Using Endoscopic Ultrasound-Guided Fine Needle Aspiration: a Pilot Study

Purpose

Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is the most reliable method for the histological diagnosis of pancreatic tumors. Rapid on-site fluorescence-guided histological diagnosis was evaluated by topically applying an enzymatically activatable probe onto the EUS-FNA samples; the probe fluoresces in the presence of γ-glutamyltranspeptidase (GGT).

Procedures

We evaluated GGT expression in pancreatic cancer cell lines in vitro. EUS-FNA was performed in 10 pancreatic tumors. After topical application of the probe, signal intensity was measured using a fluorescence imaging system for 13 min.

Results

GGT was expressed in Panc-1, AsPC-1, and AR42J, but not in KP4 cells. In samples from six cases, several regions of the specimens fluoresced and contained adequate tissue for pathological diagnosis. The remaining four non-fluorescent samples contained very small amounts of carcinoma, normal epithelial cells, or no epithelial cells. The signal intensity at 5 min was 25.5?±?7.7 and 7.7?±?0.5 in fluorescent and non-fluorescent regions, respectively (p?<?0.05).

Conclusions

Application of enzymatically activatable probe onto EUS-FNA samples would be feasible for the rapid evaluation of tissues suitable for histological diagnosis.

     

Hochintensiver fokussierter Ultraschall (HIFU) zur Linderung tumorbedingter Schmerzen bei inoperablem Pankreaskarzinom

Background

High-intensity focused ultrasound (HIFU) in combination with palliative standard therapy is an innovative and effective treatment option for pain reduction in patients with inoperable pancreatic cancer.

Objective

Evaluation of the effects of additive ultrasound (US)-guided HIFU treatment in inoperable pancreatic cancer on the sensory and affective pain perception using validated questionnaries.

Material and methods

In this study 20 patients with locally advanced inoperable pancreatic cancer and tumor-related pain were treated by US-guided HIFU (6 stage III, 12 stage IV according to UICC and 2 with local recurrence after surgery). Ablation was performed using the JC HIFU system (HAIFU, Chongqing, China) with an ultrasonic device for real-time imaging. Clinical assessment included evaluation of pain severity using validated questionnaires with particular attention to the pain sensation scale (SES) with its affective and sensory component and the numeric rating scale (NRS).

Results

The average pain reduction after HIFU was 2.87 points on the NRS scale and 57.3?% compared to the mean baseline score (n = 15, 75?%) in 19 of 20 treated patients. Four patients did not report pain relief, however, the previous opioid medication could be stopped (n = 2) or the analgesic dosage could be reduced (n = 2). No pain reduction was achieved in one patient. Furthermore, after HIFU emotional as well as sensory pain aspects were significantly reduced (before vs. 1 week after HIFU, p < 0.05 for all pain scales).

Conclusion

US-guided HIFU can be used for effective and early pain relief and reduction of emotional and sensory pain sensation in patients with locally advanced pancreatic cancer.

     

Effect of synbiotic therapy on the incidence of ventilator associated pneumonia in critically ill patients: a randomised,double-blind,placebo-controlled trial

Objective

To investigate the effect of enteral Synbiotic 2000 FORTE^® (a mixture of lactic acid bacteria and fibre) on the incidence of ventilator associated pneumonia (VAP) in critically ill patients.

Design

Prospective, randomised, double blind, placebo controlled trial.

Setting

Tertiary referral centre, general Adult Intensive Care Unit (ICU).

Patients and participants

259 enterally fed patients requiring mechanical ventilation for 48 h or more were enrolled.

Intervention

All patients were enterally fed as per a standard protocol and randomly assigned to receive either synbiotic 2000 FORTE^® (twice a day) or a cellulose-based placebo for a maximum of 28 days.

Measurements and results

Treatment group (n = 130) was well matched with placebo group (n = 129) for age (mean 49.5 and 50 years, respectively) and APACHE II score (median 17 for both). Oropharyngeal microbial flora and colonisation rates were unaffected by synbiotics. The overall incidence of VAP was lower than anticipated (11.2%) and no statistical difference was demonstrated between groups receiving synbiotic and placebo in the incidence of VAP (9 and 13%, P = 0.42), VAP rate per 1,000 ventilator days (13 and 14.6, P = 0.91) or hospital mortality (27 and 33%, P = 0.39), respectively.

Conclusions

Enteral administration of Synbiotic 2000 FORTE^® has no statistically significant impact on the incidence of VAP in critically ill patients.

     

The Effectiveness of Trimetazidine Treatment in Patients with Stable Angina Pectoris of Various Durations: Results from the CHOICE-2 Study

Introduction

Trimetazidine (TMZ) has been shown to reduce angina symptoms and to increase exercise capacity in randomized clinical trials, but more extensive data would be useful to assess its effects in real-world clinical practice and in patients with different durations of disease.

Methods

CHOICE-2 was a Russian, multicenter, 6-month, open-label, prospective observational study that assessed the effect of adding TMZ modified release 35 mg bid to antianginal treatment in a real-world setting. The present analysis of CHOICE-2 results explored the effects of adding TMZ to background antianginal therapies with regard to the duration of stable angina.

Results

A total of 741 patients with known durations of disease were divided into four groups according to stable angina pectoris (AP) duration, ranging from less than 1 year to more than 9 years. Addition of TMZ led to a significant decrease in the frequency of angina attacks and in the use of short-acting nitrates in all groups. In patients with recently diagnosed angina (AP duration < 1 year), the average number of angina attacks per week decreased significantly from 3.75 ± 4.63 to 0.67 ± 1.51 and in those with advanced disease (AP duration > 9 years) from 5.63 ± 5.24 to 1.32 ± 2.07. Angina-free walking distance also improved significantly. Addition of TMZ also improved patient well-being. Results were achieved rapidly (within 2 weeks), were maintained over 6 months, and were obtained in all patient groups regardless of angina duration.

Conclusion

TMZ added to other antianginal therapies proved to be effective for reducing angina attacks and short-acting nitrate use, increasing angina-free walking distance, and improving patient well-being in a real-life setting, irrespective of angina duration, including patients with recently diagnosed angina. This provides an opportunity for intensification of treatment early on in the disease process, with the aim of decreasing angina burden and improving patient quality of life.

Funding

Servier.

Trial Registration

ISRCTN identifier ISRCTN65209863.

Plain Language Summary

Plain language summary available for this article.

     

Olanzapine vs haloperidol: treating delirium in a critical care setting

Objective

To compare the safety and estimate the response profile of olanzapine, a second-generation antipsychotic, to haloperidol in the treatment of delirium in the critical care setting.

Design

Prospective randomized trial

Setting

Tertiary care university affiliated critical care unit.

Patients

All admissions to a medical and surgical intensive care unit with a diagnosis of delirium.

Interventions

Patients were randomized to receive either enteral olanzapine or haloperidol.

Measurements

Patient’s delirium severity and benzodiazepine use were monitored over 5 days after the diagnosis of delirium.

Main results

Delirium Index decreased over time in both groups, as did the administered dose of benzodiazepines. Clinical improvement was similar in both treatment arms. No side effects were noted in the olanzapine group, whereas the use of haloperidol was associated with extrapyramidal side effects.

Conclusions

Olanzapine is a safe alternative to haloperidol in delirious critical care patients, and may be of particular interest in patients in whom haloperidol is contraindicated.

     

Influence of age,sex, body mass index,alcohol, and smoking on shear wave velocity (p-SWE) of the pancreas

Purpose

A variety of elastographic techniques have been developed to facilitate the non-invasive assessment of tissue properties. The goal of the study was to examine the influence of gender, age, BMI, alcohol consumption, and smoking in healthy volunteers.

Methods

Of the 263 participants who met all the study inclusion criteria, 234 had successful measurements. The examination was performed with the Siemens Acuson S3000 (Siemens Healthcare, Erlangen, Germany), using the 6C1 curved array transducer with the virtual touch tissue quantification (VTQ) method.

Results

The values determined with the curved array in the head of the pancreas were 1.44 ± 0.39 m/s for women and 1.19 ± 0.29 m/s for men; in the body, the results were 1.49 ± 0.37 m/s for women and 1.26 ± 0.30  m/s for men; in the tail, the corresponding values were 1.29 ± 0.36 m/s for women and 1.05 ± 0.30 m/s for men. Comparison of gender showed that men have significantly lower mean values than women. There were significantly higher values in all parts of the organ with the increasing age of the participants (p < 0.0001). For BMI, there was a significant correlation with the values only when considering the BMI in continuous form. Alcohol consumption and smoking did not have any significant effects.

Conclusions

ARFI-VTQ is qualified for use on pancreatic tissue. Further studies are required to examine the influence of other factors in larger populations.

     

MR-imaging features of hepatocellular carcinoma capsule appearance in cirrhotic liver: comparison of gadoxetic acid and gadobenate dimeglumine

Purpose

The purpose of the study is to compare the MR-imaging features of hepatocellular carcinoma (HCC) capsule appearance on gadoxetic acid and gadobenate dimeglumine-enhanced MR imaging, using imaging-based presumptive diagnosis of HCC as the reference standard.

Methods

Gadoxetic acid and gadobenate dimeglumine-enhanced MR imaging of 51 patients with 71 HCCs were retrospectively reviewed. Three readers graded in consensus, using a five-point scale, the presence (score 4–5) of capsule appearance on images obtained during T1-weighted GRE portal venous phase (PVP), 3-min phase, and hepatobiliary phase (HBP). The Fisher's exact test and the t student unpaired test were performed.

Results

A hyperintense capsule appearance was present either on PVP or 3-min phase in 11/46 and in 24/25 HCCs imaged with gadoxetic acid and gadobenate dimeglumine-enhanced MR imaging, respectively (24% vs. 96% p < 0.001). A hypointense capsule appearance was present on HBP in 8/46 and 0/22 HCCs evaluated with gadoxetic acid and gadobenate dimeglumine-enhanced MR imaging, respectively (17% vs. 0% p = 0.046). A capsule appearance was detected either on PVP, 3-min phase, or HBP in 17/46 (37%) HCCs after gadoxetic acid injection and in 24/25 (96%) HCCs after gadobenate dimeglumine injection (p < 0.001).

Conclusions

A capsule appearance was more frequently seen on gadobenate dimeglumine-enhanced MR imaging when compared to gadoxetic acid-enhanced MR imaging.

     

Outcomes Following Implantation of Two Second-Generation Trabecular Micro-Bypass Stents in Patients with Open-Angle Glaucoma on One Medication: 18-Month Follow-Up

Introduction

The study objective was to evaluate the intraocular pressure (IOP) and medication-lowering effect of 2 second-generation trabecular micro-bypass stents in eyes with open-angle glaucoma (OAG) on one preoperative medication.

Methods

Fifty-seven qualified phakic eyes with OAG on 1 medication, preoperative medicated IOP of 18–30 mmHg, and preoperative unmedicated (post-washout) IOP of 22–38 mmHg underwent implantation of 2 second-generation trabecular micro-bypass stents in a standalone procedure. Evaluations included IOP, best-corrected visual acuity, medication use, fundus and slit lamp examinations, visual field, cup to disc ratio, pachymetry, and complications and interventions. Subjects have been followed for 18 months, and follow-up is ongoing.

Results

At Month 12 postoperative, 100% of eyes had achieved an IOP reduction ≥20% (100% had IOP ≤18 mmHg and 67% had IOP ≤15 mmHg) without medication versus preoperative unmedicated IOP, and 75% had IOP reduction ≥20% without medication versus preoperative medicated IOP. The Month 12 mean unmedicated IOP had decreased by 42%, to 14.2 ± 1.9 mmHg vs 24.4 ± 1.3 mmHg preoperatively, and this reduction was maintained through 18 months (14.4 ± 2.1 mmHg). A high safety profile was observed.

Conclusion

In this prospective, open-label, single-arm study, the standalone implantation of two second-generation trabecular micro-bypass stents in OAG patients on 1 preoperative medication resulted in IOP reduction to ≤15 mmHg and elimination of medication through 18 months, with favorable safety.

Trial Registration

ClinicalTrials.gov identifier, NCT02868190.

Funding

Glaukos Corporation, San Clemente, CA.

     

Measurement of sound pressure and temperature in tissue-mimicking material using an optical fiber Bragg grating sensor

Purpose

The experimental investigation of an optical fiber Bragg grating (FBG) sensor for biomedical application is described. The FBG sensor can be used to measure sound pressure and temperature rise simultaneously in biological tissues exposed to ultrasound. The theoretical maximum values that can be measured with the FBG sensor are 73.0 MPa and 30 °C.

Methods

In this study, measurement of sound pressure up to 5 MPa was performed at an ultrasound frequency of 2 MHz. A maximum temperature change of 6 °C was measured in a tissue-mimicking material.

Results

Values yielded by the FBG sensor agreed with those measured using a thermocouple and a hydrophone.

Conclusion

Since this sensor is used to monitor the sound pressure and temperature simultaneously, it can also be used for industrial applications, such as ultrasonic cleaning of semiconductors under controlled temperatures.

     

Quietschendes Kniegelenk nach Rekonstruktion des medialen patellofemoralen Ligaments

Introduction

Reconstruction of the medial patellofemoral ligament (MPFL) with a free gracilis or semitendinosus tendon graft has been a successful treatment for chronic patellofemoral instability between 0° and 30° of knee flexion for many years. An implant-free graft attachment on the medial facet of the patella has been shown to provide successful results.

Case report

A 26-year-old female patient was treated with MPFL reconstruction of the right knee joint. At 3 months postoperatively the patient reported a disturbing “squeaking” in the operated knee. Arthroscopic revision showed an intra-articular position of the implanted suture material at the lateral patella facet.

Conclusion

The use of implant-free tendon attachment to the patella during MPFL reconstruction has been a well-established procedure for many years with a good rate of healing. Decisive is the parallel drilling to the patellar surface, which can be intraoperatively controlled radiologically and arthroscopically. It is important to avoid intra-articular placement of suture material during this type of surgery in order to prevent the rare occurrence of joint squeaking.