Important Clinical Improvement Research Articles

Patient-reported effects of transcutaneous spinal cord stimulation on spasticity in patients with spinal cord injury

Objectives Assess pateint-reported effects of transcutaneous spinal cord stimulation (tSCS) on spasticity after multiple treatment. Design An uncontrolled prospective case series study. Setting A rehabilitation hospital. Participants A convenience sample of hospitalized adults with spinal cord injury (SCI) and lower-body spasticity limiting physical function and/or reducing quality of life (i.e. pain, sleep disturbance). Interventions Participants received 30 minutes of tSCS (continuous, asymmetrical, biphasic rectangular impulses, 100 Hz) applied for 3–6 consecutive days using NeuroTrac multiTENS® (http://quintet.no). Two electrodes were placed paravertebrally at Th11–Th12 level and two on lower abdomen. Outcome measures Penn`s Spasm Frequency and Severity Scales were used for quantifying spasticity, Numeric Rating Scales (NRS 0–10) for perceived impact of spasticity on one chosen activity of a daily living, sleep-disturbance, and pain in trunk/lower limbs due to spasticity. The outcome measures were completed through interviews conducted before the first treatment, and immediately after the last treatment. Results Seventeen people participated; injury levels C6-T12, AIS A-D, and mean age 51 years (SD 14). Fourteen participants reported a clinical important improvement in ADL performance, sleep disturbance and/or a decrease in pain due to spasticity (≥ two points on NRS). Minimal change was reported on Penn`s Spasm frequency and Severity Scales. No adverse events were observed. Conclusions The majority of the participants perceived clinically relevant improvements on at least one patient-reported outcome measure, and no adverse events were reported. This is a simple and a non-invasive treatment that may have a potential of reducing the troublesome effects of spasticity.

Association of Changes in Hand Pain With BMI, Employment, and Mental Well-Being Over Four Years in Patients With Hand Osteoarthritis.

We aimed to characterize patients with hand osteoarthritis (OA) with deteriorating or improving hand pain and to investigate patients achieving good clinical outcome after four years. We used four-year annual Australian/Canadian Hand Osteoarthritis Index (AUSCAN) pain subscale (range 0-20) measurements from the Hand OSTeoArthritis in Secondary Care cohort (patients with hand OA). Pain changes were categorized as deterioration, stable, and improvement using the Minimal Clinical Important Improvement. Good clinical outcome was categorized using the Patient Acceptable Symptom State (PASS). Associations between baseline characteristics (patient and disease characteristics, coping styles, and illness perceptions) and outcomes were investigated using multinomial or binary logistic regression, adjusted for baseline pain, age, sex, and body mass index (BMI). A total of 356 patients (83% female, mean age 60.6 years, mean AUSCAN score 9.1) were analyzed. Pain improved for 38% of patients, deteriorated for 30% of patients, and remained stable for 32% of patients over four years. Four-year pain development followed annual trends. At baseline, 44% of patients reached PASS, and 49% of patients reached PASS at follow-up. Higher BMI, coping through comforting cognitions, and illness comprehension were positively associated with pain deterioration. Higher AUSCAN function score, mental well-being, and illness consequences were negatively associated with pain improvement. Employment (positive) and emotional representations (negative) were associated with both improvement and deterioration. Higher baseline AUSCAN function, tender joint count, and symptoms attributed to hand OA were associated negatively with PASS after four years. The pain course of patients with hand OA is variable, not inevitably worsening, and various factors may play a role. Whether modification of these risk factors can influence pain outcomes requires further investigation.

Improvement in spinal pain at night and its impact on long-term outcomes in radiographic axial spondyloarthritis: Results from Ixekizumab COAST-V randomised trial

Spinal pain at night is a major contributor to the patient burden of radiographic axial spondyloarthritis (r-axSpA), resulting in substantial functional limitations and impairment of health-related quality of life (QoL). Ixekizumab (IXE), an interleukin-17A inhibitor, has shown efficacy in patients with r-axSpA. To assess spinal pain at night improvement up to week (W) 52 in COAST-V and to determine if clinically important improvement in spinal pain at night at W16 is associated with improvement in disease activity and other patient-reported outcomes (PROs) at W16 and W52. The 52 W phase 3 COAST-V trial investigated the efficacy of IXE in patients with r-axSpA that were naïve to biological disease-modifying anti-rheumatic drug (bDMARD). Patients were randomised to IXE every two weeks (Q2W), IXE every four weeks (Q4W), adalimumab (ADA) Q2W, or placebo up to W16. Patients were categorised as achieving or not achieving a ≥3-point improvement, considered a clinically important improvement (CII), in spinal pain at night at W16. Associations between achieving CII in spinal pain at night at W16 and change from baseline in disease activity (ASDAS, ASAS40), Fatigue severity NRS, JSEQ, WPAI and the SF-36 survey, were tested using analysis of covariance (continuous variables) and logistic regression (binary variables). At W16, 63.0 % (n=51), 46.7 % (n=42), and 32.2 % (n=28) of patients treated with IXE Q4W, ADA Q2W, and placebo, respectively, had reached a CII in spinal pain at night. Of those who were treated with IXE Q4W and achieved a CII in spinal pain at night at W16, 58.8 % and 66.7 % achieved an ASDAS <2.1 at W16 and W52 while 25.5 % and 29.4 % of patients also achieved ASDAS <1.3 at W16 and W52, respectively. Results at W16 and W52 show an improvement in disease activity, functioning, and health related QoL for patients who achieved a CII in spinal pain at night at W16. A larger proportion of patients treated with IXE Q4W achieved rapid and clinically meaningful improvement in spinal pain at night versus placebo, with improvements maintained up to W52. Achieving a CII in spinal pain at night at W16 was associated with improved disease activity, functioning, PROs, and QoL at W16 and W52. ClinicalTrials.gov NCT02696785.

Aspects scientifiques et cliniques des médiations thérapeutiques : quelle prise en soin pour les victimes de l’explosion du port de Beyrouth ?

Aspects scientifiques et cliniques des médiations thérapeutiques : quelle prise en soin pour les victimes de l’explosion du port de Beyrouth ?

Urinary Symptoms Change and Quality of Life After Robotic Radical Prostatectomy: A Secondary Analysis of a Randomized Controlled Trial

To present the patient-reported quality of life (QoL) outcomes from a prospective, randomized controlled trial comparing the use of pelvic floor muscle training (PFMT) and duloxetine after robot-assisted radical prostatectomy (RARP). We identified 213 men with organ-confined disease having post-RARP urinary incontinence who were randomly assigned to received PFMT, duloxetine, combined PFMT-duloxetine and pelvic floor muscle home exercises. Urinary symptoms burden was measured by marked clinical important difference improvement (MCID) defined by using the International Prostate Symptom Score (IPSS) difference of -8 points (ΔIPSS ≤-8). QoL was assessed according to Visual Analog Scale (VAS), King's Health Questionnaire (KQH), and International Index of Erectile Function (IIEF-5). Multivariable regression analyses aimed to predict MCID, burden of urinary symptoms (IPSS ≥8), and patients reporting to be satisfied (IPSS QoL ≤2) or comfortable (VAS ≤1) post-RARP. Moderate to severe urinary symptoms decreased from 48% preoperatively to 40%, 34%, and 23% at 3, 6, and 12months post-RARP. After surgery, MCID improvement was observed in 19% of patients, and deterioration in 3.3%. Large prostate was the only factor associated to MCID (OR 1.03 [95%CI 1.01-1.05], P=.005). At 6months, patients reached the same degree of preoperative satisfaction. Neurovascular bundle preservation was the only predictor of being comfortable regarding urinary symptoms postoperatively (OR 12.8 [CI95% 1.47-111.7], P=.02 at 3months) and was also associated to higher median postoperative IIEF-5. Despite urinary incontinence following RARP, patients with larger prostates experience a reduction of lower urinary tract symptoms within a year, which subsequently elevates QoL. Furthermore, nerve-sparing surgery augments erectile function and urinary outcomes, shaping postoperative QoL.

Sex differences in the effectiveness of first-line tumour necrosis factor inhibitors in axial spondyloarthritis: results from the EuroSpA Research Collaboration Network

ObjectiveEvidence indicates reduced treatment effectiveness of TNFi in women with axial spondyloarthritis (axSpA) compared with men. We aimed to investigate sex differences in treatment response and retention rates over 24...

Upadacitinib effectiveness and factors associated with minimal disease activity achievement in patients with psoriatic arthritis: preliminary data of a real-life multicenter study

BackgroundUpadacitinib (UPA) is a selective JAK inhibitor recently approved for the treatment of psoriatic arthritis (PsA). In this post-approval study, we aimed to evaluate the effectiveness and safety of UPA over 24 weeks and identify clinical predictors of response, in a multicentric cohort of patients affected by PsA.MethodsOne hundred and twenty-six patients with PsA treated with UPA were enrolled in 10 Italian centres. UPA effectiveness outcomes, such as the proportion of patients with MDA status, DAPSA remission, and low disease activity, ASDAS-CRP inactive and low disease activity, and change from baseline in DAPSA and ASDAS-CRP scores, were evaluated every 12 weeks until week 24. The proportion of DAPSA minor, moderate, and major improvement, and ASDAS clinically important improvement (CII) and major improvement (MI) were considered as well. All treatment-related adverse events were collected during the observation period. Clinical predictors of MDA response at week 24 were evaluated through multivariate analysis.ResultsAt baseline, 124/126 (98%) and 54/126 (43%) patients showed peripheral and axial involvement, respectively; 110 (87%) patients were intolerant or resistant to biologic DMARDs. At 24 weeks, MDA status, DAPSA remission, and ASDAS-CRP inactive disease were achieved in 47%, 23%, and 48% of patients, respectively. Minor, moderate, and major DAPSA improvement was observed in 67%, 39%, and 23%, respectively; while 65% and 35% achieved ASDAS-CRP CII and MI, respectively. The mean change from baseline was 15.9 ± 13.5 (p < 0.001) for DAPSA and 1.21 ± 0.97 (p < 0.001) for ASDAS-CRP. Thirteen patients (10%) discontinued UPA due to a lack of efficacy or non-serious adverse events. No serious adverse events were observed. Male gender (OR 2.54, 95% CI 1.03–6.25 p = 0.043), being naïve to biological DMARDs (OR 4.13, 95% CI 1.34–12.71, p = 0.013) and elevated baseline CRP (OR 2.49, 95% CI 1.02–6.12, p = 0.046) were associated with MDA response at week 24.ConclusionsThis is one of the first real-life studies supporting the effectiveness of UPA and its safety profile in PsA patients. Furthermore, the study identifies predictors of MDA response to UPA treatment at 6 months.

P282 PAUCISYMPTOMATIC POST–COVID MYOCARDITIS IN A YOUNG ATHLETE DURING THE DIAGNOSTIC INVESTIGATIONS BEFORE RETURNING TO COMPETITIVE PRACTICE, POSSIBLE USEFULNESS OF THE GLS ANALYSIS

Abstract It is now known that the Covid19 infection can cause myocardial inflammatory damage. Several studies have shown that the echocardiographic parameter of the global longitudinal strain (GLS) was reduced compared to the general population even in paucisymptomatic patients. A young competitive athlete came to our observation for the diagnostic investigations before returning to competitive practice (return to play protocol) after Sars–Cov2 infection. The electrocardiogram did not show significant abnormalities as well as spirometry examination. Negative inflammation indexes and markers of myocardial damage were observed. The cycloergometer test showed no signs of myocardial distress, rapid chronotropic increase and dyspnea at 100W work load. HolterECG was performed showing 830 isolated ventricular ectopic beats. Echocardiographic examination showed preserved left ventricular systolic function (FEVS 59% – Simpson method) with a moderate reduction of GLS parameter –16,9%. The cardiopulmonary exercise test (CPET) showed an early anaerobic threshold and a normal pVO2max but not in line with the presumed range for a top–level athlete. Putting together the symptoms described, the CPET data and GLS parameter, despite the negative first–level investigations he underwent MRI that documented a myocardial edema in the mid–basal region of inferior and inferolateral walls of the left ventricle. Suitability for competitive practice was blocked, a gradual physical readaptation path was started and therapy with low–dose bisoprolol was set. An important clinical improvement is reported at the 6–month follow–up with evidence of normalization of the GLS parameter –23%. The CPET howed a realignment of the HR/VCO2 curve with a late threshold and increment of pVO2max. The 6–month control MRI examination showed almost no signs of myocardial inflammation and so the patient was made suitable for returning to competitive sport. In our case first–level investigations did not support any hypothesis of myocardial inflammation. The presence of stress symptoms confirmed by CPET data but especially the reduction of GLS parameter led to a deepening investigation with MRI that confirmed the presence of myocardial inflammatory lesion. Our case suggests that within a “return to play” protocol for athletes with recent SarsCov2 infection, the analysis of left ventricular systolic function by GLS may represent an additional useful element to be considered in support of standard investigations.

P134 Efficacy of Upadacitinib on Psoriatic Arthritis with Axial Involvement Defined by Investigator Assessment and PRO-Based Criteria: Results from two Phase 3 Studies

P134 Efficacy of Upadacitinib on Psoriatic Arthritis with Axial Involvement Defined by Investigator Assessment and PRO-Based Criteria: Results from two Phase 3 Studies

Guillain-Barré syndrome following a Type 2 leprosy reaction: A case report

A 39-years-old male patient with previously treated borderline lepromatous (BL) leprosy, presented with paresthesia and dysesthesia in the feet and hands, associated with fever, arthralgia, and erythema nodosum during a Type-2 leprosy reaction (LR) episode. This evolved in 3 days to a flaccid tetraparesis with areflexia, with gait impairment, in addition to clinical signs of dysautonomia, such as tachycardia, tachydyspnea, and cranial nerve involvement. The nerve conduction study was compatible with an acute inflammatory demyelinating polyradiculoneuropathy and the cerebrospinal fluid (CSF) analysis confirmed an inflammatory pattern. The patient was treated with intravenous immunoglobulin, showing an important clinical improvement. This case describes the unusual association between leprosy and Guillain-Barré syndrome (GBS), emphasizing the importance of recognition of this condition.

External validation of the alternative Ankylosing Spondylitis Disease Activity Score in three randomized clinical trials of ixekizumab.

The alternative ASDAS (altASDAS) is an index that can be used when patient global assessment is unavailable. Our aim was to test the truth and discrimination aspects according to OMERACT filter 2.0 of the altASDAS in an external cohort. Cohorts from the COAST trials of ixekizumab (COAST-V, -W, -X; 16-week primary endpoint) enrolling radiographic/non-radiographic axial SpA patients were pooled. The ASDAS [original formula with patient global assessment (PGA)] and altASDAS were calculated. Truth was assessed by agreement with the continuous ASDAS [intraclass correlation coefficients (ICCs)] and ASDAS disease activity (DA) states (weighted κ), Bland-Altman plots [mean difference (MD) and 95% limits of agreement (LoA)] and Pearson's correlations between altASDAS/ASDAS and other constructs. Discrimination was tested by the ability of altASDAS to distinguish high/low DA according to nocturnal pain >6/10 as an external anchor and agreement (κ) with ASDAS in major improvement (MI) and clinically important improvement (CII). A total of 958 patients were included. For truth, agreement with ASDAS was very good (ICC = 0.99, κ = 0.91), MD with ASDAS was 0.03 (95% LoA -0.31-0.24) and correlation coefficients of altASDAS with related constructs were within a prespecified 0.3-wide band around those between ASDAS and the same construct. For discrimination, the altASDAS discriminated between DA states and agreed with ASDAS response (κ MI = 0.91, CII = 0.93). The altASDAS was truthful and discriminative in an external cohort and as such has been fully validated to be used in cases when PGA is unavailable.

Feasibility and role of echocontrast evaluation of patients with LVAD

Abstract Background Advanced heart failure is a clinical syndrome characterized by persistent or progressive symptoms of heart failure despite optimal medical therapy. Left ventricular assist device (LVAD) brings survival benefits and improvement in quality of life, compared with conventional medical treatments. Development of Right ventricle failure in patients with LVAD has a direct effect on mortality and hospitalization. Purpose Evaluation of clinical safety and feasibility of echocontrast in patients implanted with 3 different types of LVAD; improvement in the visualization of heart structures; intra and inter-operator agreement of RV assesement with and without contrast. Methods 43 patients were implanted with LVAD, 7 patients (16%) with Jarvik 2000, 31 (72%) with HeartMAte 3, 5 (12%) with (HeartWAre HVAD). Nine patients (21%) had contraindication or refused contrast. In 3 (7%) patients was technically challenging to obtain apical images at all levels. Two (5%) patients lost their follow-up. Our final population was of 29 (67%) patients (mean age 65±7 y; 100% Male). We assessed the reproducibility of these measurements between two different expert blind operators. Results Total 329 (64%) of 516 RV wall segments were available for qualitative analysis without contrast vs 451 (87%) with contrast (p&amp;lt;0.001) with a significant improvement of the evaluability of regional contractility (especially due to the better evaluation of medial and apical segments of lateral and anterior walls) and FAC (41% vs 90%, p&amp;lt;0.001). Evaluation of TAPSE, TR and sPAP was similar with and without contrast (p=NS). All the RV parameters showed little inter-operator variability when measured with contrast. TAPSE, FAC, and RWMA showed an excellent reproducibility (ICC &amp;gt;0.86) while it was good for 2D-baseline derived parameters (ICC = 0.74) showing improvement of inter operator reproducibility in the evaluation of regional contractility in the contrast echocardiography modality. Conclusion EC is safe with all the types of LVAD examined. Accurate and reproducible visualization of RV is imperative for reliability of information, a routine use of EC could play a pivotal role in interpreting RV features. EC improves RV morphologic and functional judgment allowing greater accuracy and precision in the assessment of both global and regional RV functions. This finding may have important clinical improvement, especially in the future for analysis focused in RV prognostic role in LVAD patients. Funding Acknowledgement Type of funding sources: None.

Evaluation of Demographic, Clinical and Autopsy Data of Autopsied Maternal Deaths in Turkey

Aim: Maternal mortality is an important public health issue. In this study, it is aimed to evaluate pregnancy related maternal deaths in a multi-dimensional manner, focusing on not only demographic and clinical characteristics but also autopsy results by including the maternal death cases having autopsy reports.&#x0D; Material and Method: There were 1037 pregnancy related deaths in Turkey, between 2010 and 2014, and 17.3 % (n=180) of them had an autopsy report. Autopsied maternal deaths were evaluated in this sutdy. Data of autopsied pregnancy related deaths were obtained from the nationwide registration system of Woman and Reproductive Health Department of Turkish Ministry of Health and Turkish Ministry of Justice-Council of Forensic Medicine and evaluated retrospectively. Characteristics and cause of maternal deaths autopsied between 2010 and 2014 were evaluated. Age, cause of death, pregnancy state at the time of death, place of birth, mode of delivery, time of death, pregnancy outcomes, place of death, and delay-model were evaluated.&#x0D; Results: In this study, 61.1% (n=110) of all pregnancy related deaths were ≥30 years of age. Direct maternal deaths were 35% (n=63) of the cases, such as hemorrhage 14.5% (n=26), embolus 6.7% (n=12), uterine rupture 5% (n=9), preeclampsia/eclampsia 4.4% (n=8) and others 4.4% (n=8). Indirect maternal deaths were 56.1% (n=101) of the cases, such as cardiovascular disease 37.2% (n=67), infection 7.8% (n=14), cerebrovascular disease 6.7% (n=12), and others 4.4% (n=8). In 8.9% (n=16) of the cases, the cause of death was not determined. Deaths occurred in the postpartum period in 61.1% (n=110) of the cases. Deaths occurred in a healthcare facility in 71.1% (n=128) of the cases. One or more delays were determined in 33.9% (n=61) of the cases. &#x0D; Conclusion: According to the results of the present study, cardiovascular disease related to maternal mortality has been found to be an increasing, important public health concern to consider for maternal health routines. In addition, as a second outcome of this study, we can emphasize that, although, the exact cause of death could not be determined even after autopsy in 16 cases (8.9%), autopsy is still one of the most valuable assessment tools to highlight important possible clinical and administrative improvements to reduce maternal mortality.

The Effect of Core Stabilization Training on Improving Gait and Self-Perceived Function in Patients with Knee Osteoarthritis: A Single-Arm Clinical Trial.

The treatment of patients with knee osteoarthritis is typically focused on the involved lower extremity. There is a gap in the literature concerning the effectiveness of core stabilization training on the treatment of patients with knee osteoarthritis. This investigation aimed to determine whether core stabilization improved the gait and functional ability of patients with knee osteoarthritis. Eighteen participants with knee osteoarthritis completed the six-week core stabilization intervention. Participants completed the gait motion analysis and the Knee Injury and Osteoarthritis Outcome Score to assess self-perceived function, pre- and post-intervention. Gait speed improved (p = 0.006, d = 0.59), while the external knee adduction moment decreased (p = 0.034, d = −0.90). Moreover, self-reported function improved (p < 0.001, d = 1.26). The gait speed and external knee adduction moment changes met minimal detectable change thresholds, while gait speed also met the minimal clinically important difference. A six-week core stabilization program can thus improve gait speed and reduce the external knee adduction moment, which is tied to disease progression. Increased functional scores post-intervention indicate an important clinical improvement. Core stabilization training is a safe and potentially effective treatment option for this population.

Novel method for direct retransfusion reduces blood transfusions in descending and thoracoabdominal aneurysm repair.

Allogenic blood product usage is associated with worse outcomes in open repair of descending and thoracoabdominal aortic aneurysms. This pilot study evaluated the safety and efficacy of a novel modification of the left heart bypass (LHB) circuit to reduce intraoperative blood transfusions. In modified LHB, pump suckers collected shed blood that was directly retransfused through a femoral vein cannula. In standard LHB, cellsavers were used to collect, wash, and retransfuse shed blood. Consecutive patients undergoing elective surgical descending or thoracoabdominal aneurysm repair using modified (N.=12) or standard (N.=21) LHB were compared. Intraoperative blood product use was the primary outcome. Hypotensive episodes, lactate levels, and adverse events (early mortality, spinal cord injury, renal and respiratory insufficiency) were secondary outcomes. Groups were comparable regarding pre- and intraoperative variables. No perfusion-related adverse events occurred. With modified LHB, intraoperative blood product use was significantly reduced: packed red blood cells by 60% from 10 to 4 units (P=0.002), fresh frozen plasma by 70% from 17 to 5 units (P<0.001) as well as retransfused cellsaver volume by 75%, from 4500 mL to 1110 mL (P<0.001). Hemodynamic instability occurred in 1 (8.3%) vs. 6 (29%), P=0.22 and overall lactate levels were significantly reduced (P=0.045) with modified LHB. Adverse events combined occurred in 1/12 vs. (P=0.022). The novel modified LHB with direct retransfusion was safe and associated with significantly reduced intraoperative blood product use, reduced lactate production and improved clinical outcomes as compared to standard LHB and could represent an important clinical improvement.

Predictors of ASDAS-CRP inactive disease in axial spondyloarthritis during treatment with TNF-inhibitors: Data from the EuroSpA collaboration

In patients with axial spondyloarthritis (axSpA) initiating their first tumor necrosis factor alpha-inhibitor (TNFi), we aimed to identify common baseline predictors of Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP) inactive disease (primary objective) and clinically important improvement (CII) at 6 months, and drug retention at 12-months across 15 European registries. Baseline demographic and clinical characteristics were collected. Outcomes were investigated per registry and in pooled data using logistic regression analyses on multiply imputed data. The consistency of baseline predictors in individual registries justified pooling the data. In the pooled dataset (n=21,196), the 6-month rates for ASDAS inactive disease and ASDAS CII were 26% and 51%, and the 12-month drug retention rate 65% in patients with available data (n=9,845, n=6,948 and n=21,196, respectively). Nine common baseline predictors of ASDAS inactive disease, ASDAS CII and 12-month drug retention were identified, and the odds ratios (95%-confidence interval) for ASDAS inactive disease were: age, per year: 0.97 (0.97-0.98), men vs. women: 1.88 (1.60-2.22), current vs. non-smoking: 0.76 (0.63-0.91), HLA-B27 positive vs. negative: 1.51 (1.20-1.91), TNF start year 2015-2018vs. 2009-2014: 1.24 (1.06-1.45), CRP>10vs. ≤10mg/l: 1.49 (1.25-1.77), one unit increase in health assessment questionnaire (HAQ): 0.77 (0.58-1.03), one-millimeter (mm) increase in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) fatigue and spinal pain: 0.99 (0.99-1.00) and 0.99 (0.99-1.99), respectively CONCLUSION: Common baseline predictors of treatment response and adherence to TNFi could be identified across data from 15 European registries, indicating that they may be universal across different axSpA populations.

Dietary and nutritional interventions in children with cerebral palsy: A systematic literature review.

Cerebral palsy is an extremely severe brain injury associated with multiple nutritional and clinical issues, such as underweight, gastroesophageal reflux, constipation, and nutrient deficiency. Evidence-based dietary and nutritional interventions may improve the quality of life of children with cerebral palsy. Systematically review randomized clinical trials evaluating nutritional and dietary interventions in the clinical, nutritional, and neurodevelopmental aspects of children with cerebral palsy. A search was performed in electronic databases (LILACS, Medline, Web of Science, Embase, Scopus, Cochrane Library, ClinicalTrials.gov, Brazilian Digital Library of Theses and Dissertations, ProQuest Dissertations and Theses Database, OpenGrey) using keywords. The search was firstly performed in May 2020 and updated on June 18th, 2021. Eligible studies were randomized clinical trials, that included children between 2 and 12 years old, and evaluated the effect of nutritional or dietetic interventions on clinical, nutritional or neurodevelopmental outcomes. Risk of bias was investigated using the RoB-2 tool. The study was registered on PROSPERO (CRD42020181284). Fifteen studies were selected. Positive results included the use of whey-based or pectin-enriched enteral formulas for gastroesophageal reflux (n = 6); 25-hydroxy-vitamin D supplementation for hypovitaminosis D (n = 2); supplementation with lipid mixture or diet with high-density energy for improvements in anthropometric measures (n = 2); supplementation with probiotics, prebiotics, symbiotics or magnesium for constipation (n = 2); nutritional support system for gross motor function (n = 1); lactoferrin and iron hydroxide polymaltose for iron deficiency anemia (n = 1); and educational intervention to improve feeding skills (n = 1). The overall risk of bias was high for 60% of the studies, and some concerns were raised for the remaining 40%. Some promising dietary and nutritional interventions may promote important clinical improvements for patients with cerebral palsy. However, evidence is weak, as few clinical trials have been published with many methodological errors, leading to a high risk of bias.

P104 FEASIBILITY AND ROLE OF ECHOCONTRAST EVALUATION IN PATIENTS WITH LVAD

Abstract Background Advanced heart failure is a clinical syndrome characterized by persistent or progressive symptoms of heart failure despite optimal medical therapy. Left ventricular assist device (LVAD) brings survival benefits and improvement in quality of life, compared with conventional medical treatments. Development of Right ventricle failure in patients with LVAD has a direct effect on mortality and hospitalization. Purpose evaluation of clinical safety and feasibility of echocontrast in patients implanted with 3 different types of LVAD; improvement in the visualization of heart structures; intra and inter–operator agreement of RV assesement with and without contrast. Methods 43 patients were implanted with LVAD, 7 patients (16%) with Jarvik 2000, 31 (72%) with HeartMAte 3, 5 (12%) with (HeartWAre HVAD). Nine patients (21%) had contraindication or refused contrast. In 3 (7%) patients was technically challenging to obtain apical images at all levels. Two (5%) patients lost their follow–up. Our final population was of 29 (67%) patients (mean age 65±7 y; 100% Male). We assessed the reproducibility of these measurements between two different expert blind operators Results Total 329 (64%) of 516 RV wall segments were available for qualitative analysis without contrast vs 451 (87%) with contrast (p &amp;lt; 0.001) with a significant improvement of the evaluability of regional contractility (especially due to the better evaluation of medial and apical segments of lateral and anterior walls) and FAC (41% vs 90%, p &amp;lt; 0.001). Evaluation of TAPSE, TR and sPAP was similar with and without contrast (p=NS). All the RV parameters showed little inter–operator variability when measured with contrast. TAPSE, FAC, and RWMA showed an excellent reproducibility (ICC &amp;gt;0.86) while it was good for 2D–baseline derived parameters (ICC = 0.74) showing improvement of inter operator reproducibility in the evaluation of regional contractility in the contrast echocardiography modality. Conclusion EC is safe with all the types of LVAD examined. Accurate and reproducible visualization of RV is imperative for reliability of information, a routine use of EC could play a pivotal role in interpreting RV features. EC improves RV morphologic and functional judgment allowing greater accuracy and precision in the assessment of both global and regional RV functions. This finding may have important clinical improvement, especially in the future for analysis focused in RV prognostic role in LVAD patients.

OA38 Efficacy and safety of upadacitinib in patients with psoriatic arthritis and axial involvement

Abstract Background/Aims Patients (pts) with psoriatic arthritis (PsA) and axial involvement exhibit greater disease activity and quality of life impairments compared with those without axial involvement. Here the aim was to characterize PsA pts with and without axial involvement and compare efficacy of UPA vs placebo (PBO) in PsA pts with axial involvement. Methods In SELECT-PsA 1 (NCT03104400; N = 1705, non-biologic DMARD IR) and SELECT-PsA 2 (NCT03104374; N = 642, biologic DMARD IR), pts with active PsA (≥3 swollen and ≥3 tender joints), active or historical psoriasis, and on ≤ 2 non-biologic DMARDs were randomized to once daily UPA 15 mg, UPA 30 mg, adalimumab 40 mg every other week (SELECT-PsA 1 only), or PBO. Efficacy was assessed in pts with axial involvement (diagnosed by investigators based on totality of information) pooled from the two studies. Assessments included change from BL in BASDAI, BASDAI Q2 (neck/back/hip pain) and Q3 (joint swelling/pain), and the AS Disease Activity Score (ASDAS-CRP), and percentage with BASDAI 50 response, ASDAS inactive disease (ID), ASDAS low disease activity (LDA), ASDAS major improvement (MI), and ASDAS clinically important improvement (CII). Uveitis and inflammatory bowel disease (IBD) adverse events were reviewed. Data on 24-week PBO-controlled period are presented. Results Prevalence of axial involvement was 31.3% in SELECT-PsA 1 and 34.2% in SELECT-PsA 2 (Table). Treatment with UPA 15 mg and 30 mg resulted in significantly greater improvements from BL in the BASDAI, BASDAI Q2 (neck/back/hip pain) and Q3 (joint swelling/pain) and ASDAS-CRP at weeks 12 and 24 vs PBO. Similarly, significantly higher percentages of pts on UPA 15 mg and 30 mg achieved BASDAI 50, ASDAS ID, LDA, MI, and CII at weeks 12 and 24 vs PBO. One pt on UPA 30 mg had incident uveitis, and no IBD was reported on UPA. Conclusion PsA pts with axial involvement had higher BL disease burden compared with those without axial involvement. UPA was efficacious in treating axial symptoms in pts with psoriatic spondylitis. Disclosure A. Deodhar: Consultancies; A.D. has received consultancy fees from Novartis, Pfizer, AbbVie, Eli-Lilly, UBC Pharma, GlaxoSmithKline, Galapagos, Janssen, Boehringer Ingelheim, Celgene. Member of speakers’ bureau; A.D. is a member of the speakers' bureau of Novartis and Pfizer. Grants/research support; A.D. has received research grants from Novartis, Pfizer, AbbVie, Eli-Lilly, UBC Pharma, GlaxoSmithKline. R. Ranza: Consultancies; R.R. has acted as a consultant to AbbVie, Janssen, Lilly, Novartis, Pfizer. Member of speakers’ bureau; R.R. is a member of the speakers' bureau of AbbVie, Janssen, Lilly, Novartis, Pfizer. Grants/research support; R.R. has received grant/research support from AbbVie, Janssen. F. Ganz: Shareholder/stock ownership; F.G. is an employee of AbbVie and may hold stock or options. T. Gao: Shareholder/stock ownership; T.G. is an employee of AbbVie and may hold stock and options. J. Anderson: Shareholder/stock ownership; J.A. is an employee of AbbVie and may hold stock and options. A. Ostor: Consultancies; A.O. has acted as a consultant for AbbVie, BMS, Roche, Janssen, Lilly, Novartis, UBC, Pfizer, Gilead, Paradigm.

Feasibility and role of echocontrast evaluation of patients with LVAD

Abstract Funding Acknowledgements Type of funding sources: None. Background In patients with Advanced heart failure (AHF) long-term support with durable mechanical circulatory support (MCS) devices such as left ventricular assist device (LVAD) brings survival benefits and improvement in quality of life, compared with conventional medical treatments. Development of RVF in patients with LVAD has a direct effect on mortality and is associated with prolonged length of stay in intensive care unit and in-hospital stay and with poor quality of life. Purpose: the evaluation of clinical safety and feasibility of echocontrast (EC) in patients implanted with 3 different types of LVAD (HeartWAre HVAD, Jarvik 2000, HeartMate 3); the assessment of the improvement in the visualization of heart structures; the intra and inter-operator agreement of RV measurements (FAC, TAPSE, sPAP, TR, regional wall motion abnormalities) with and without contrast. Methods: Between 2014 and 2019, 43 patients were implanted with LVAD, in particular 7 (16%) patients were implanted with Jarvik 2000, 31 (72%) with HeartMAte 3, 5 (12%) pts with HeartWAre HVAD. Nine patients (21%) either had contraindication or refused contrast injection. In 3 (7%) patients, it was technically challenging to obtain apical images at all levels. Two (5%) patients lost their follow-up. Our final population was of 29 (67%) patients. We also assessed the reproducibility of these measurements between two different expert operators (blind analysis). Results: We observed no allergic reaction to EC. Total 329 (64%) of 516 RV wall segments were available for qualitative analysis without contrast vs 451 (87%) with contrast (p &amp;lt; 0.001) with a significant improvement of the evaluability of regional contractility and FAC (41% vs 90%, p &amp;lt; 0.001). Evaluation of TAPSE, TR and sPAP was similar with and without contrast (p = NS) All the RV parameters showed little inter-operator variability when measured with contrast. TAPSE, FAC, and RWMA showed an excellent reproducibility (ICC &amp;gt;0.86) while it was good for 2D-baseline derived parameters (ICC = 0.74) showing improvement of inter operator reproducibility in the evaluation of regional contractility in the contrast echocardiography modality. Conclusion: EC is safe with all the types of LVAD we examined. Accurate and reproducible visualization of RV is imperative for reliability of information, a routine use of EC could play a pivotal role in interpreting RV features. EC improves RV morphologic and functional judgment; allowing greater accuracy and precision in the assessment of both global and regional RV functions. This finding may have important clinical improvement, especially in the future for analysis focused in RV prognostic role in LVAD patients