Shear wave elastography evaluation in pediatric testicular microlithiasis: a comparative study

Purpose

The aim of this study was to evaluate the testicular parenchyma in pediatric patients with testicular microlithiasis by shear wave elastography (SWE) and compare the values with normal control subjects.

Methods

Twenty-three patients previously diagnosed with testicular microlithiasis under follow-up for 20 ± 11 months were included in the study group. In the control group, 31 patients with no medical history that could affect testicular tissue were prospectively included. Forty-six testes in the study group and 62 testes in the control group were evaluated with gray-scale ultrasound and SWE.

Results

There were no differences in age and testes volume between the study and control groups. The mean SWE values of all testes based on elasticity and speed parameters in the study group were 8.84 ± 2.86 kPa and 1.66 ± 0.26 m/s, respectively. In the control group, mean SWE values were 5.26 ± 1.17 kPa and 1.31 ± 0.14 m/s, respectively. Elasticity values were significantly higher in testes with microlithiasis as compared with the control group (p < 0.001).

Conclusions

SWE evaluation demonstrates the effects of ultrastructural changes in elasticity that are not detected on gray-scale ultrasound. SWE is a more reliable method in follow-up examinations for pediatric testicular microlithiasis.

     

The utility of ultrasound elastography in differentiation of endometriomas and hemorrhagic ovarian cysts

Purpose

To investigate the feasibility of acoustic radiation force impulse imaging in differentiation of endometriomas and hemorrhagic ovarian cysts.

Materials and methods

We evaluated 84 ovarian cysts with high internal echogenicity diagnosed in 70 consecutive women. We excluded simple cysts and hemorrhagic cysts containing septations or mural nodules with detectable flow on Doppler ultrasonography. We obtained the elastographic shear wave velocity (SWV) value of the cysts that could be endometriomas or hemorrhagic ovarian cysts.

Results

Among the 78 ovarian cysts in 70 women without any septation or mural nodule, there were 42 endometriomas and 36 hemorrhagic ovarian cysts. Analysis of median SWV values of the ovarian cysts showed that the endometriomas had considerably higher levels of stiffness compared to the hemorrhagic ovarian cysts [median SWV 4.20 ± 0.42 vs 2.54 ± 1.04 m/s, p < 0.001]. A SWV cutoff value greater than 3.81 m/s yielded sensitivity and specificity values of 82.1 and 79.2 % respectively, for differentiation of endometriomas from hemorrhagic ovarian cysts.

Conclusion

Sonoelastography is a novel imaging technique that enables us to evaluate the stiffness of adnexal lesions. The accurate discrimination of endometriomas and hemorrhagic ovarian cysts is important for avoiding unnecessary surgical procedures. ARFI imaging has a high sensitivity and specificity for distinguishing endometrioma from hemorrhagic ovarian cysts.

     

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.

     

Efficacy of a Novel Prefilled,Single-Use,Needle-Free Device (Zeneo<Superscript>®</Superscript>) in Achieving Intramuscular Agent Delivery: An Observational Study

Background

It is recognized that, as a result of variation in tissue anatomy, current auto-injectors may have insufficient needle length to achieve successful intramuscular agent delivery in a number of patients. The Zeneo^® auto-injector is a novel prefilled, single-use, needle-free device currently in development for intradermal, subcutaneous, and intramuscular agent delivery across a variety of clinical indications. We aimed to evaluate delivery depth of the device calibrated at pressure appropriate for intramuscular (IM) administration.

Methods

This was a prospective single-center study in healthy adult volunteers, in whom each received a single injection of saline into the anterolateral thigh. Using sequential MRI scans, we measured skin-to-muscle distance (STMD) agent delivery depth, and the success of IM agent penetration. Device dynamic pressure measurements were also recorded.

Results

Results are reported for 37 subjects with evaluable MRI scans; 19 men, 18 women; mean age 38 years (range 20–58); mean BMI 27.0 kg/m² (range 21.2–30.8 kg/m²). Mean STMD values were 18.6 mm (range 13.4–23.6 mm) in women and 10.0 mm (range 5.0–21.7 mm) in men, with gender differences due primarily to greater subcutaneous thickness in women. A trend for greater STMD in subjects with BMI greater than 25 kg/m² was seen. Mean injectate penetration depths of 30.1 mm (range 20.2–45.6 mm) were observed with values similar in male and female subjects. Successful IM delivery was reported in 95% of subjects. When failure occurred, this was not due to inadequate injection depth. Device pressure (P _max) had the greatest influence on injectate muscle penetration.

Conclusion

Use of the Zeneo^® auto-injector achieves delivery depth that ensures intramuscular delivery in both men and women, regardless of BMI. Consistent with other reported data, STMD is greater in women.

Funding

Crossject.

     

Shear wave elastography of the spleen: evaluation of spleen stiffness in healthy volunteers

Purpose

The aim of this study was to assess the mean value of spleen stiffness measured by Shear wave elastography in healthy patients and its dependence on age, sex, and spleen dimensions, and to evaluate the repeatability of this method.

Methods

The final study group included 59 healthy volunteers without any clinical evidence of liver disease, portal hypertension, hematological disorders, and without any pathological ultrasonographic spleen findings. Each patient underwent abdominal ultrasound examination and elastography of the liver and the spleen.

Results

The mean value of spleen stiffness was 16.6 ± 2.5 kPa. In the group of men (N = 25), it was 17.3 ± 2.7 kPa, and in the group of women (N = 34), it was 16.1 ± 2.2 kPa. The study confirmed no correlation between spleen stiffness and sex, age of patients, and spleen size. Coefficient of repeatability and correlation coefficient between the results of the first and the second measurement showed good but not ideal repeatability of the measurement results.

Conclusion

Our outcomes may be a reference point for evaluating spleen stiffness in research on patients with various illnesses.

     

Distribution of lung ventilation in spontaneously breathing neonates lying in different body positions

Objective

The aim of our study was to determine the effect of the irregular spontaneous breathing pattern and posture on the spatial distribution of ventilation in neonates free from respiratory disease by the non-invasive imaging method of electrical impedance tomography (EIT). Scanning of spontaneously breathing neonates is the prerequisite for later routine application of EIT in babies with lung pathology undergoing ventilator therapy.

Design

Prospective study.

Setting

Neonatal intensive care unit at a university hospital.

Patients

Twelve pre-term and term neonates (mean age: 23 days; mean body weight: 2,465 g; mean gestational age: 34 weeks; mean birth weight: 2,040 g).

Interventions

Change in body position in the sequence: supine, right lateral, prone, supine.

Measurements and results

EIT measurements were performed using the Göttingen GoeMF I system. EIT scans of regional lung ventilation showing the distribution of respired air in the chest cross-section were generated during phases of rapid tidal breathing and deep breaths. During tidal breathing, 54.5±8.3%, 55.2±10.5%, 59.9±8.4% and 54.2±8.5% of inspired air (mean values ± SD) were directed into the right lung in the supine, right lateral, prone and repeated supine postures respectively. During deep inspirations, the right lung ventilation accounted for 52.6±7.9%, 68.5±8.5%, 55.4±8.2% and 50.5±6.6% of total ventilation respectively.

Conclusion

The study identified the significant effect of breathing pattern and posture on the spatial distribution of lung ventilation in spontaneously breathing neonates. The results demonstrate that changes in regional ventilation can easily be determined by EIT and bode well for the future use of this method in paediatric intensive care.

     

Quantitative assessment of muscular stiffness in children with cerebral palsy using acoustic radiation force impulse (ARFI) ultrasound elastography

Purpose

To evaluate the feasibility of quantitative analysis of muscle stiffness in the medial gastrocnemius muscle (GCM) by acoustic radiation force impulse (ARFI) ultrasound elastography in children with spastic cerebral palsy (CP).

Methods

Seventeen children with spastic CP and 25 healthy children participated in the study between the years 2016–2017. The medial GCM in the CP group was assessed using the Modified Ashworth Scale (MAS) by a physiatrist. ARFI was used to measure the shear-wave velocities (SWVs) of the medial GCM. The mean SWV value for each MAS score was calculated and used for statistics.

Results

The mean SWV values of the medial GCM in the CP and healthy groups were 3.17 ± 0.81 m/s (mean ± SD) and 1.45 ± 0.25 m/s (mean ± SD), respectively. The SWV of the medial GCM significantly increased in the CP patients when compared with controls (p < 0.001). In addition, the SWV values were correlated with the MAS scores (p < 0.001). The interobserver agreement expressed as the interclass correlation coefficient was 0.65 (95% CI 0.33–0.84, p < 0.001).

Conclusions

ARFI imaging demonstrated a difference in muscle stiffness in the medial GCM between the CP and healthy groups. This method is a feasible imaging modality for the noninvasive assessment of contracting muscles in children with CP.

     

Administration of Micronized Purified Flavonoid Fraction During Sclerotherapy of Reticular Veins and Telangiectasias: Results of the National,Multicenter, Observational Program VEIN ACT PROLONGED-C1

Introduction

Sclerotherapy is a common technique for the removal of intradermal veins. This study examined the rationale for prescribing micronized purified flavonoid fraction (MPFF) in clinical, etiological, anatomic, pathophysiologic (CEAP) class C1 patients with dilated intradermal veins scheduled for sclerotherapy.

Methods

In a national, multicenter, observational program, physicians recruited CEAP C1s patients scheduled for sclerotherapy. The decision to prescribe adjuvant MPFF (1000 mg/day for 6 weeks beginning 2 weeks before sclerotherapy) was made according to usual practice. Disease severity and treatment outcomes were assessed at baseline and 4 weeks post-sclerotherapy using a visual analog scale (VAS) as well as quality-of-life (CIVIQ-14) and patient satisfaction (Darvall) questionnaires.

Results

A total of 70 physicians recruited 1150 patients: 1071 (93%) women, 79 (7%) men. Mean age (±?SD) was 40.7?±?10.7 years (range 18–74) and mean body mass index was 23.6?±?3.3 kg/m². Reticular veins were observed in 42.1% of patients and 57.9% had telangiectasias. MPPF was prescribed to 905 patients (79%). Sclerotherapy was associated with statistically significant decreases in mean VAS scores for leg heaviness, pain, sensation of swelling, night cramps, and itching. For each symptom, MPFF-treated patients showed a more pronounced improvement than those undergoing sclerotherapy alone: mean VAS pain score with MPFF decreased from 1.90?±?2.30 to 0.30?±?0.62 versus 1.72?±?1.93 to 0.52?±?0.99 with sclerotherapy alone; mean VAS leg heaviness score with MPFF decreased from 2.80?±?2.43 to 0.47?±?1.07 versus 2.38?±?2.23 to 0.76?±?0.85 with sclerotherapy alone. Patient quality-of-life indicators improved with symptom resolution, particularly pain, and for each indicator the observed improvement was greater with MPFF. The outcomes of treatment exceeded patient expectations. Fewer patients experienced sclerotherapy-induced hyperpigmentation with adjunctive MPFF versus sclerotherapy alone (33.9% versus 41.2%, respectively, P?=?0.034). No adverse events related to MPFF were observed.

Conclusion

Resolution of venous symptoms post-sclerotherapy was greater in patients treated with MPFF compared with those undergoing sclerotherapy alone, supporting the rationale for use of MPFF in patients undergoing sclerotherapy.

Funding

Servier.

     

Quantitative assessment of muscle stiffness with acoustic radiation force impulse elastography after botulinum toxin A injection in children with cerebral palsy

Purpose

Our objective in this study was to assess the changes in medial gastrocnemius muscle (GCM) stiffness after botulinum toxin A (BTA) injection in children with cerebral palsy (CP) by using acoustic radiation force impulse (ARFI) elastography and to research the usability of this technique in clinical practice.

Materials and methods

Twenty-four spastic lower extremities of 12 children with CP were assessed. BTA injection treatment was applied to the medial GCM. Muscle stiffness was measured with the ARFI technique before the procedure and a month after the procedure. The patients were assessed with the modified Ashworth scale (MAS) in the physiotherapy department at about the same time. Shear wave velocity (SWV) values and MAS scores before and after the treatment were compared.

Results

Mean SWV values were measured as 3.20 ± 0.14 m/s before BTA and as 2.45 ± 0.21 m/s after BTA, and the difference between them was found to be statistically significant (p < 0.001). Mean MAS score (2.33 ± 0.70) after BTA decreased significantly when compared to the score before BTA (2.96 ± 0.62) (p = 0.001). SWV values positively correlated with MAS scores (ρ = 0.578, p = 0.003). The interobserver agreement expressed as interclass correlation coefficient (ICC) was 0.65 (95% CI 0.33–0.84, p < 0.001).

Conclusion

ARFI elastography for identifying structural changes that occur in the spastic muscle after BTA injection in children with CP can yield more valuable information with combined use of MAS.

     

Impact of Region-of-Interest Delineation Methods,Reconstruction Algorithms,and Intra- and Inter-Operator Variability on Internal Dosimetry Estimates Using PET

Purpose

Human dosimetry studies play a central role in radioligand development for positron emission tomography (PET). Drawing regions of interest (ROIs) on the PET images is used to measure the dose in each organ. In the study aspects related to ROI delineation methods were evaluated for two radioligands of different biodistribution (intestinal vs urinary).

Procedures

PET images were simulated from a human voxel-based phantom. Several ROI delineation methods were tested: antero-posterior projections (AP), 3D sub-samples of the organs (S), and a 3D volume covering the whole-organ (W). Inter- and intra-operator variability ROI drawing was evaluated by using human data.

Results

The effective dose estimates using S and W methods were comparable to the true values. AP methods overestimated (49 %) the dose for the radioligand with intestinal biodistribution. Moreover, the AP method showed the highest inter-operator variability: 11 ± 1 %.

Conclusions

The sub-sampled organ method showed the best balance between quantitative accuracy and inter- and intra-operator variability.

     

Automatic adjustment of pressure support by a computer-driven knowledge-based system during noninvasive ventilation: a feasibility study

Objective

To evaluate the feasibility of using a knowledge-based system designed to automatically titrate pressure support (PS) to maintain the patient in a “respiratory comfort zone” during noninvasive ventilation (NIV) in patients with acute respiratory failure.

Design and setting

Prospective crossover interventional study in an intensive care unit of a university hospital.

Patients

Twenty patients.

Interventions

After initial NIV setting and startup in conventional PS by the chest physiotherapist NIV was continued for 45?min with the automated PS activated.

Measurements and results

During automated PS minute-volume was maintained constant while respiratory rate decreased significantly from its pre-NIV value (20?±?3 vs. 25?±?3?bpm). There was a trend towards a progressive lowering of dyspnea. In hypercapnic patients PaCO₂ decreased significantly from 61?±?9 to 51?±?2?mmHg, and pH increased significantly from 7.31?±?0.05 to 7.35?±?0.03. Automated PS was well tolerated. Two system malfunctions occurred prompting physiotherapist intervention.

Conclusions

The results of this feasibility study suggest that the system can be used during NIV in patients with acute respiratory failure. Further studies should now determine whether it can improve patient-ventilator interaction and reduce caregiver workload.

     

Shear wave velocity measurement of upper trapezius muscle by color Doppler shear wave imaging

Purpose

Skeletal muscle stiffness is thought to be the result of increased tissue hardness, but measurement accuracy has been dependent on operator technique. We have proposed a novel shear wave real-time imaging method (color Doppler shear wave imaging: CD SWI) with continuous shear waves excited from the tissue surface by a mechanical vibrator.

Methods

Using the method, shear wave velocity was measured for the upper trapezius muscle. Adaptive shear wave velocity measurement by means of quality estimation of shear wave wavefront was adopted. We recruited 23 male volunteers with no history of orthopedic disease and recorded shear wave propagation to assess the intra- and inter-observer reliability. For intra-observer reliability, one observer took two measurements separated by a time delay, and the intra-class correlation coefficient (ICC) was calculated (1,1). For inter-observer reliability, ICC (2,1) was calculated from both observers’ measurements.

Results

Mean propagation speed was 3.75 ± 0.47 (first) and 3.71 ± 0.49 m/s (second) for Observer A (ICC (1,1) = 0.91 [95% CI 0.76–0.96]) and 3.80 ± 0.53 m/s for Observer B (ICC (2,1) = 0.83 [95% CI 0.56–0.94]).

Conclusions

This result suggests that our technique is satisfactorily reliable and has potential for future application in various fields, such as evaluation of muscle condition or the effects of rehabilitation.

     

Efficiency of quantitative echogenicity for investigating supraspinatus tendinopathy by the gray-level histogram of two ultrasound devices

Purpose

The gray-level histogram of ultrasound is a promising tool for scanning the hypoechogenic appearance of supraspinatus tendinopathy, and the aim of this study was to test the hypothesis that the gray-level value of the supraspinatus tendon in the painful shoulder has a lower value on B-mode images even though in different ultrasound devices.

Methods

Sixty-seven patients who had unilateral shoulder pain with rotator cuff tendinopathy underwent bilateral shoulder ultrasonography, and we compared the mean gray-level values of painful shoulders and contralateral shoulders without any pain in each patient using two ultrasound devices. The echogenicity ratio (symptomatic/asymptomatic side) of two ultrasound devices was compared.

Results

A significant difference existed between the symptomatic shoulder and contralateral asymptomatic shoulder (p < 0.001) on the mean gray-level value measurements of each device. The symptomatic-to-asymptomatic tendon echogenicity ratio of device A was 0.919 ± 0.090 in the transverse plane and 0.937 ± 0.081 in the longitudinal plane, and the echogenicity ratio of device B was 0.899 ± 0.113 in the transverse plane and 0.940 ± 0.113 in the longitudinal plane.

Conclusions

The decline of the mean gray-level value and the echogenicity ratio of the supraspinatus tendon in the painful shoulder may be utilized as a useful sonographic reference of unilateral rotator cuff lesions.

Level of evidence

Diagnostic level III.

     

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.

     

Hypoxia-Targeting Fluorescent Nanobodies for Optical Molecular Imaging of Pre-Invasive Breast Cancer

Purpose

The aim of this work was to develop a CAIX-specific nanobody conjugated to IRDye800CW for molecular imaging of pre-invasive breast cancer.

Procedures

CAIX-specific nanobodies were selected using a modified phage display technology, conjugated site-specifically to IRDye800CW and evaluated in a xenograft breast cancer mouse model using ductal carcinoma in situ cells (DCIS).

Results

Specific anti-CAIX nanobodies were obtained. Administration of a CAIX-specific nanobody into mice with DCIS xenografts overexpressing CAIX showed after 2 h a mean tumor-to-normal tissue ratio (TNR) of 4.3?±?0.6, compared to a TNR of 1.4?±?0.2 in mice injected with the negative control nanobody R2-IR. In DCIS mice, a TNR of 1.8?±?0.1 was obtained. Biodistribution studies demonstrated an uptake of 14.0?±?1.1 %I.D./g in DCIS?+?CAIX tumors, 4.6?±?0.8 %I.D./g in DCIS tumors, while 2.0?±?0.2 %I.D./g was obtained with R2-IR.

Conclusions

These results demonstrate the successful generation of a CAIX-specific nanobody-IRDye800CW conjugate that can be used for rapid imaging of (pre-)invasive breast cancer.

     

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.

     

Sulodexide in Patients with Chronic Venous Disease of the Lower Limbs: Clinical Efficacy and Impact on Quality of Life

Introduction

Chronic venous disease (CVD) of the lower limbs is a common problem. It is more prevalent in women than in men and has a significant impact on patients’ quality of life (QoL) and on the healthcare system. The aim of this study was to evaluate the efficacy of sulodexide in adult patients with CVD of the lower limbs and its effect on patients’ QoL.

Methods

Patients with CVD were treated with sulodexide [250 LSU (lipasemic units) twice daily] for 3 months in a setting of real-life clinical practice. The endpoints of this observational non-comparative, open-label prospective study were the clinical efficacy of sulodexide (evaluated by scoring objective and subjective symptoms with a Likert-type scale) and the impact of sulodexide therapy on patients’ QoL [assessed using the chronic venous insufficiency quality of life questionnaire (CIVIQ)].

Results

The study included 450 patients (mean age 46.9 ± 10.5 years, range 17–78 years). A greater percentage of patients were female (65.4%). Three months of treatment with sulodexide significantly improved all objective and subjective symptoms (p < 0.0001). Overall, patients reported a significant improvement in all QoL scores (p < 0.0001). Adverse events were spontaneously reported by two patients (one case of epigastric pain and one of gastric pain with vomiting).

Conclusion

Oral sulodexide significantly improves both objective and subjective symptoms, as well as functional and psychological aspects of QoL in patients with CVD.

Funding

No funding or sponsorship was received for this study. Sponsorship for article processing charges and open access fees was provided by Alfa Wassermann.

     

Determination of functional residual capacity by oxygen washin-washout: a validation study

Objective

To validate a new system for functional residual capacity (FRC) measurements using oxygen washin/washout in spontaneously breathing humans. The system (LUFU, Drägerwerk AG, Lübeck, Germany) consists of an unmodified EVITA 4 ventilator, a side-stream paramagnetic oxygen sensor and a dedicated software.

Design

Laboratory study and measurements in spontaneously breathing volunteers.

Setting

Pulmonary function laboratory of a university hospital.

Participants

20 healthy and 15 lung diseased volunteers.

Interventions

FRC was measured by LUFU (LUFU-FRC) and by helium dilution (He-FRC); intra-thoracic gas volume (ITGV) was determined by body plethysmography. Each measurement cycle consisted of four independent LUFU-FRC determinations (step change of FiO₂ from 0.21 to 0.5 and back and from 0.21 to 1.0 and back), two helium-dilution runs and two body box measurements. Repeatability and agreement between methods were determined by comparing different measurements of one technique and by comparing different techniques among each other.

Measurements and results

Repeatability of LUFU-FRC was estimated by comparing washin to washout and the different FiO₂steps. The difference of the means was 3.7% at the most. Agreement between methods resulted in the following differences (mean?±?standard deviation of differences) for healthy and lung-diseased volunteers, respectively: LUFU-FRC vs. He-FRC –0.40?±?0.50?L (0.02?±?0.95?L), LUFU-FRC vs. ITGV –0.43?±?0.54?L (–0.18?±?0.61?L) and He-FRC vs. ITGV –0.03?±?0.43?L (–0.20?±?0.98?L).

Conclusions

LUFU is a non-invasive method for the determination of FRC that requires only minor additional equipment and no modification to the ventilator. It can be used in difficult conditions such as breathing patterns with variations from breath to breath. The results of this study show that LUFU is sufficiently reliable and repeatable to warrant its clinical application.

     

Intrapartum transperineal ultrasound for evaluating uterine contraction intensity in the second stage of labor

Purpose

To clarify whether intrapartum transperineal ultrasound (ITU) can be used to evaluate uterine contraction intensity, and whether the intensity is associated with the duration of the second stage.

Methods

A prospective observational study was performed involving 86 women with a normal singleton term fetus and more than three contractions every 10 min. ITU was performed for contractile and non-contractile periods of labor at the beginning of the second stage, and one representative “angle of progression (AoP)” image was selected for each period. The Mann–Whitney U test was used to compare ?AoP, the difference between the two angles, depending on the duration of the second stage. Receiver operating characteristic curves were used to evaluate the probability of duration of the second stage ≤50 min in nulliparous women.

Results

Among nulliparous women, ΔAoP differed significantly according to the duration of the second stage (52.5° ± 5.0° for ≤50 min vs. 30.9° ± 2.1° for >50 min; P < 0.001). Receiver operating characteristic curve analysis showed that approximately 85% of nulliparous women with ΔAoP greater than 40° delivered within 50 min.

Conclusion

These findings could be utilized in the evaluation of uterine contraction intensity, and ?AoP measurement could be used to predict the duration of the second stage of labor in nulliparous women.