Prospective Nonrandomized Study Research Articles

Medialized Dome and Anatomic Onlay Patella Designs in the Modern Posterior Stabilized Rotating Platform Total Knee Arthroplasty Demonstrate No Clinical or Radiological Differences at One Year

BackgroundA successful outcome after total knee arthroplasty (TKA) includes the restoration of patellofemoral function. Modern patella component designs in TKA include a medialized dome and more recently, an anatomic design. There is a paucity of literature comparing these 2 implants. MethodsThis prospective nonrandomized study examined 544 consecutive TKAs with patella resurfacing using a posterior-stabilized, rotating platform knee prothesis performed by a single surgeon. A medialized dome patella design was used in the first 323 cases and an anatomic design in the subsequent 221 cases. Patients were assessed preoperatively, at 4 weeks and 1-year post-TKA for Oxford Knee Score (OKS) (total, pain, and kneeling components) and range of movement (ROM). Radiolucent lines (RLLs), patellar tilts and displacements, as well as reoperations were assessed at 1-year post-TKA. ResultsAt 1-year post-TKA, both groups demonstrated similar improvements in ROM, OKS, pain, and kneeling scores, and had a similar incidence of fixed-flexion deformity (all P > .05). Radiographically, there was no clinically significant difference in the incidence of RLLs, patellar tilts, and displacements. The prevalence of reoperations (1.8 versus 3.2%, P = .526) was similar between the designs with no patella-related complications. ConclusionBoth medialized dome and anatomic patella designs result in improved ROM and OKS with no patella-related complications. However, our study showed no differences between the designs at 1 year.

Development of a biomarker panel for assessing cardiovascular risk in diabetic patients with chronic limb-threatening ischemia (CLTI): a prospective study

BackgroundLower-extremity endovascular revascularization (LER) is often required for diabetic patients with chronic limb threatening ischemia (CLTI). During the post-revascularization period patients may unpredictably experience major adverse cardiac events (MACE) and major adverse limb events (MALE). Several families of cytokines are involved in the inflammatory process that underlies the progression of atherosclerosis. According to current evidence, we have identified a panel of possible biomarkers related with the risk of developing MACE and MALE after LER. The aim was to study the relationship between a panel of biomarkers - Interleukin-1 (IL-1) and 6 (IL-6), C-Reactive Protein (CRP), Tumor Necrosis Factor-α (TNF-α), High-Mobility Group Box-1 (HMGB-1), Osteoprotegerin (OPG), Sortilin and Omentin-1- at baseline, with cardiovascular outcomes (MACE and MALE) after LER in diabetic patients with CLTI.MethodsIn this prospective non-randomized study, 264 diabetic patients with CLTI undergoing endovascular revascularization were enrolled. Serum levels of each biomarker were collected before revascularization and outcomes’ incidence was evaluated after 1, 3, 6 and 12 months.ResultsDuring the follow-up period, 42 cases of MACE and 81 cases of MALE occurred. There was a linear association for each biomarker at baseline and incident MACE and MALE, except Omentin-1 levels that were inversely related to the presence of MACE or MALE. After adjusting for traditional cardiovascular risk factors, the association between each biomarker baseline level and outcomes remained significant in multivariable analysis. Receiver operating characteristics (ROC) models were constructed using traditional clinical and laboratory risk factors and the inclusion of biomarkers significantly improved the prediction of incident events.ConclusionsElevated IL-1, IL-6, CRP, TNF-α, HMGB-1, OPG and Sortilin levels and low Omentin-1 levels at baseline correlate with worse vascular outcomes in diabetic patients with CLTI undergoing LER. Assessment of the inflammatory state with this panel of biomarkers may support physicians to identify a subset of patients more susceptible to the procedure failure and to develop cardiovascular adverse events after LER.

Indocyanine Green Tracer-Guided Radical Robotic Distal Gastrectomy Using the Firefly™ System Improves the Quality of Lymph Node Dissection in Patients with Gastric Cancer

BackgroundThis study investigated indocyanine green (ICG) as an intraoperative tool for improving lymph node dissection quality in radical robotic distal gastrectomy (RDG) for gastric cancer by comparing the rate of lymph node (LN) noncompliance with or without use of the Firefly™ system. MethodsPatients with potentially resectable gastric cancer including cT1-T4a, N0/ + , M0 were registered in a prospective nonrandomized cohort study at our institution between March 2019 and December 2022. Patients were assigned to the da Vinci surgical system with Firefly system (F group) or that without Firefly system (non-F group). F group patients received endoscopic peritumoral injection of ICG to the submucosa one day before surgery. Rate of LN noncompliance, number of harvested LNs, and short-term outcomes were compared. ResultsOf the 94 patients in this study, 55 underwent Firefly system-guided RDG and 39 underwent conventional RDG. The mean [SD] total number of harvested lymph nodes in F group, 31.2 [10.2], was significantly higher than that harvested in non-F group (25.6 [12.6]; p = 0.026). The LN noncompliance rate in F group was lower than that in non-F group (32.7% vs. 61.5%, p = 0.006). The mean number of LNs harvested in F group was significantly higher than that harvested in non-F group (31.2 [10.2] vs. 25.7 [12.6], p = 0.02). Significant differences were found between the F vs. non-F groups in blood loss and postoperative hospital stay (83.9 [75.1] vs. 301.9 [766.7] mL; p = 0.003 and 13.4 vs. 17.4 days, p = 0.049). ConclusionThe Firefly system-assisted ICG tracer improved LN dissection quality without compromising safety.

Redefining 18F DCFPyl PSMA-PET detected local recurrence from radical prostatectomy histopathology.

18F-DCFPyL PET localises tumour recurrence in patients with biochemical recurrence post-radical prostatectomy. Correlations exist between disease recurrence and poor histopathological parameters such as the presence of extra prostatic extension (EPE) and positive surgical margins. We aim to assess topographic concordance between these histopathological features and the location of the PSMA PET local recurrences, qualitatively and quantitatively. Our cohort was selected from the 100 men who received a 18F-DCFPyL PET scan through IMPPORT trial, a prospective non-randomised study completed by GenesisCare Victoria. Eligibility included patients with a rising PSA (>0.2 ng/mL) post radical prostatectomy and PSMA PET detected local recurrence. Histopathological parameters collated included the location of tumour, EPE and positive margins. Criteria for the location and 'concordance' between histopathological features and local recurrences were predefined. 24 patients were eligible, median age was 71 years old, median PSA 0.37ng/ml and time between prostatectomy and PSMA PET was 2.6 years. 15 patients had recurrences within the vesicourethral anastomotic region and 9 within the lateral surgical margins. 100% concordance in the left to right plane between tumour location and local recurrence was found, with 79% of these lesions concordant three-dimensionally; across cranio-caudal, left-right and anterior-posterior planes. 10/16 (63%) patients' with EPE and 5/9 (55.5%) of patients' with positive margins had three-dimensional concordance between their pathology and their local recurrence. In quantitative assessment, 17 of the 24 patients, had local recurrences that correlated with the location of their original tumour in the cranio-caudal plane. Local recurrence is highly concordant with the position of the tumour within the prostate. Predicting the location of local recurrence using the location of the EPE and positive margins is less helpful. Further investigation into this field, could impact surgical technique and salvage radiotherapy clinical target volume.

Impact of SGLT2 inhibitors on the mechanisms of myocardial dysfunction in type 2 diabetes: A prospective non-randomized observational study in patients with type 2 diabetes mellitus without overt heart disease

AimsThis prospective observational study evaluated the possible mechanisms of action of SGLT2 inhibitors (SGLT2i) in patients with type 2 diabetes mellitus (T2DM) without overt heart disease. MethodsThe study was designed to verify whether SGLT2i impact biomarkers of: myocardial stress–NT-proBNP, inflammation–high sensitivity C-reactive protein, oxidative stress –myeloperoxidase, functional and structural echocardiographic parameters, in patients with T2DM on metformin (heart failure stages A and B) who needed treatment intensification with a second antidiabetic agent. The patients were divided in two groups – the ones planned to receive SGLT2i or DPP-4 inhibitor (except saxagliptin). At baseline, and after six months of therapy, 64 patients underwent blood analysis, physical and echocardiography examination. ResultsThere were no significant differences between the two groups in terms of biomarkers of myocyte and oxidative stress, inflammation and blood pressure. Body mass index, triglycerides, aspartate aminotransferase, uric acid, E/E′, deceleration time and systolic pressure in the pulmonary artery significantly decreased, while stroke volume, indexed stroke volume, high-density lipoprotein, hematocrit and hemoglobin significantly increased in the group on SGLT2i. ConclusionsAccording to the results, SGLT2i mechanisms of action comprise rapid changes in body composition and metabolic parameters, reduced cardiac load and improvement in diastolic and systolic parameters.

Cellular and humoral immune responses after a third dose of SARS-CoV-2 mRNA vaccine in lung transplant recipients in Japan

BackgroundLung transplant (LTx) recipients are at higher risk of infection with severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2). There is an increasing demand for additional analysis regarding the efficacy and safety of after the initial series of mRNA SARS-CoV-2 vaccines in Japanese transplant recipients. MethodIn this open-label, nonrandomized prospective study carried out at Tohoku University Hospital, Sendai, Japan, LTx recipients and controls received third doses of either the BNT162b2 or the mRNA-1273 vaccine, and the cellular and humoral immune responses were analyzed. ResultsA cohort of 39 LTx recipients and 38 controls participated in the study. The third dose of SARS-CoV-2 vaccine promoted much greater humoral responses at 53.9 % of LTx recipients than after the initial series at 28.2 % of patients without increasing the risk of adverse events. However, still fewer LTx recipients responded to the SARS-CoV-2 spike protein with the median IgG titer of 129.8 AU/mL and with the median IFN-γ level of 0.01 IU/mL when compared to controls with those of 7394 AU/mL and 0.70 IU/mL, respectively. ConclusionAlthough the third dose of mRNA vaccine in LTx recipients was effective and safe, impaired cellular and humoral responses to SARS-CoV-2 spike protein were noted. Given lower antibody production and establishing vaccine safety, repeating the administration of mRNA vaccine will lead to robust protection in such a high-risk population (jRCT1021210009).

Opioid-Sparing Protocol for Endocrine Surgery (OSPREY): A Prospective Study.

Thyroid and parathyroid operations are amongst the most commonly performed surgeries in the world; however, there remains a paucity of prospective clinical trials evaluating the efficacy of opioid-sparing protocols following surgery. This prospective non-randomized study was performed between March and October 2021. Participants self-selected their cohort of either an opioid-sparing protocol of acetaminophen/ibuprofen or a treatment-as-usual protocol with opioids. Primary endpoints were Overall Benefit of Analgesia Scores (OBAS) and opioid use as reported in daily medication logs. Data were recorded over seven days. Multivariable regression, pooled variance t-tests, Mann-Whitney test, and chi-square tests were used to evaluate the results. A total of 87 participants were recruited; 48 participants opted for the opioid-sparing arm while 39 participants opted for the treatment as usual arm. Patients in the opioid-sparing arm used significantly less opioids (morphine equivalents 0.77 ± 1.71 vs. 3.34 ± 5.87, p=0.042) but had no significant difference in OBAS (p=0.37). Multivariable regression analysis demonstrated no significant difference in mean OBAS between treatment arms when controlling for age, sex, and type of surgery (p=0.88). There were no major adverse events in either group. An opioid-sparing treatment algorithm based on use of acetaminophen/ibuprofen may offer a safe and effective treatment algorithm compared to a primary opioid focused treatment pathway. Randomized adequately-powered studies are needed to confirm these findings.

A prospective analysis of robotic three-stage esophagectomy for carcinoma of the esophagus in a tertiary care cancer centre.

e16078 Background: This study is to evaluate the safety and technical feasibility of total robot-assisted three-stage esophagectomy in terms of: Completeness of surgery, margin status, lymph nodes harvested, learning curve, docking time and total operating time, and associated morbidity and mortality. Methods: It is a prospective non-randomised study from Nov 2016 to Nov 2022 with a total of 168 patients. Inclusion criteria: Histologically proven squamous cell carcinoma, adenocarcinoma of the intrathoracic esophagus surgically resectable (T1-3,N0 -1,M0); ECOG performance status: 0,1 or 2. Exclusion criteria: Carcinoma of cervical esophagus; patients unfit for general anesthesia; stage IV disease. Results: In a total of 168 patients, 52% had Squamous cell carcinoma and 48% had Adenocarcinoma; 8% had upper thoracic, 44.5% mid thoracic and 47% lower thoracic lesions. Mean docking time of 33 mins and mean operating time of 321 min. Average hospital stay of 7 days with average of 44 lymph nodes retrieved and mean blood loss of 280 ml. Intra operative complications of RLN injury in 2%, Thoracic duct injury in 1.6%, and Azygous vein injury in 1%.Post operative complications such as delayed gastric emptying in 3.5%, anastomotic leak in 2.9%, pleural effusion in 2.4%, wound infection in 0.6% and re-exploration in 1.7%. Conclusions: Robotic-assisted esophagectomy has its own unique benefits of very low conversion rates, short learning curve, good quality lymphadenectomy in supra-azygous and bilateral recurrent laryngeal nerve area, less painful with faster recovery even in aged patients with significant co-morbidities. Future RCT may confirm the lower incidence of major complications, and similar OS and DFS compared to open approaches.[Table: see text][Table: see text]

Direct Anatomic Registration in Computer-Assisted Total Hip Arthroplasty Improves Accuracy of Acetabular Cup Alignment.

Computer-assisted total hip arthroplasty using direct anatomic registration (DAR) with acetabular center axis software is an alternative method to the indirect anterior pelvic plane method. The software maps the center of hip rotation and orientation of the native acetabulum in 3 dimensions. This study aimed to evaluate the accuracy of acetabular cup alignment using DAR navigation combined with a mechanical guide device (MGD). This prospective nonrandomized controlled study included 106 patients who underwent primary cementless total hip arthroplasty through the posterolateral approach. Fifty-four patients in the study group underwent DAR combined with MGD, whereas 52 patients underwent MGD only for acetabular cup positioning. Plain radiographs of both hips and computerized tomographic scans were obtained 2 months postoperatively for the evaluation of acetabular cup inclination and anteversion, respectively. The acetabular cup alignment in the study group was within the Lewinnek safe zone more than that in the control group (81.5% vs 59.6%, P < .05). The study group had a mean inclination angle of 43.88° (standard deviation [SD] 5.38) and anteversion angle of 12.82° (SD 5.99), whereas the control group had 41.10° (SD 6.79) and 12.82° (SD 9.53), respectively. There were no significant differences in estimated blood loss, length of stay, and Harris hip scores at preoperative and 3 and 6 months postoperatively, except for the operative time, which was longer in the study group (P < .01). There was 1 posterior hip dislocation in each group. DAR navigation combined with MGD provides better accuracy for acetabular cup positioning within the Lewinnek safe zone compared with the conventional technique.

Anterior deltoid muscle reflection using a deltopectoral approach is safe and does not influence outcome of reverse shoulder arthroplasty.

The deltopectoral approach is well accepted for shoulder arthroplasty procedures. The extended deltopectoral approach with detachment of the anterior deltoid from the clavicle allows increased joint exposure and can protect the anterior deltoid from traction injury. The efficacy of this extended approach has been demonstrated in anatomical total shoulder replacement surgery. However, this has not been shown in reverse shoulder arthroplasty (RSA). The primary aim of this study was to evaluate the safety of the extended deltopectoral approach in RSA. The secondary aim was to evaluate the performance of the deltoid reflection approach in terms of complications, surgical, functional and radiological outcomes up to 24 months post-surgery. A prospective non-randomized comparative study was performed between January 2012 and October 2020 including 77 patients in the deltoid reflection group and 73 patients in the comparative group. Decision for inclusion was based on patient and surgeon factors. Complications were recorded. Patients were followed up for at least 24 months to evaluate their shoulder function and ultrasound evaluation. Functional outcome measures included the Oxford Shoulder Score (OSS), Disabilities of the Arm, Shoulder and Hand (DASH) score, American Shoulder Elbow Surgeons score (ASES), pain intensity (VAS 0-100), range of motion (forward flexion (FF), abduction (AD), and external rotation (ER)). A regression analysis was performed to evaluate any factors of influence on the VAS. There were no significant differences in the rate of complications between the two groups (14.5% in the deltoid reflection group and 13.8% in the comparative group, p=0.915). Ultrasound evaluation was available in 64 (83.1%) patients, and no proximal detachment was observed. In addition, there were no significant differences in functional outcome measures both preoperatively and at 24 months post-surgery between the groups on Mean VAS pain, OSS, DASH, ASES, FF, ABD, and ER. Adjustment for possible confounders in a regression model indicated that only prior surgery significantly influenced the VAS pain (p=0.031, 95%CI 0.574 - 11.67) after surgery. Deltoid reflection (p=0.068), age (p=0.466), sex (p=0.936), glenoid graft (p=0.091), prosthesis manufacturer (p=0.382) and preop VAS score (p=0.362) were not of influence. Results of this study show an extended deltopectoral approach for RSA is safe. Selected reflection of the anterior deltoid muscle improved exposure and prevents anterior deltoid muscle injury followed by re-attachment. Patients had similar functional scores preop and at 24 months compared to a comparative group. Furthermore, ultrasound evaluation showed intact re-attachments.

Two-year Skeletal Effects of Sleeve Gastrectomy in Adolescents with Obesity Assessed with Quantitative CT and MR Spectroscopy.

Background Sleeve gastrectomy (SG) is effective in the treatment of cardiometabolic complications of obesity but is associated with bone loss. Purpose To determine the long-term effects of SG on vertebral bone strength, density, and bone marrow adipose tissue (BMAT) in adolescents and young adults with obesity. Materials and Methods This 2-year prospective nonrandomized longitudinal study enrolled adolescents and young adults with obesity who underwent either SG (SG group) or dietary and exercise counseling without surgery (control group) at an academic medical center from 2015 to 2020. Participants underwent quantitative CT of the lumbar spine (L1 and L2 levels) to assess bone density and strength, proton MR spectroscopy to assess BMAT (L1 and L2 levels), and MRI of the abdomen and thigh to assess body composition. Student t and Wilcoxon signed-rank tests were used to compare 24-month changes between and within groups. Regression analysis was performed to evaluate associations between body composition, vertebral bone density, strength, and BMAT. Results A total of 25 participants underwent SG (mean age, 18 years ± 2 [SD], 20 female), and 29 underwent dietary and exercise counseling without surgery (mean age, 18 years ± 3, 21 female). Body mass index (BMI) decreased by a mean of 11.9 kg/m2 ± 5.21 [SD] after 24 months in the SG group (P < .001), while it increased in the control group (mean increase, 1.49 kg/m2 ± 3.10; P = .02). Mean bone strength of the lumbar spine decreased after surgery compared with that in control subjects (mean decrease, -728 N ± 691 vs -7.24 N ± 775; P < .001). BMAT of the lumbar spine increased after SG (mean lipid-to-water ratio increase, 0.10 ± 0.13; P = .001). Changes in vertebral density and strength correlated positively with changes in BMI and body composition (R = 0.34 to R = 0.65, P = .02 to P < .001) and inversely with vertebral BMAT (R = -0.33 to R = -0.47, P = .03 to P = .001). Conclusion SG in adolescents and young adults reduced vertebral bone strength and density and increased BMAT compared with those in control participants. Clinical trial registration no. NCT02557438 © RSNA, 2023 See also the editorial by Link and Schafer in this issue.

Clinical pharmacist in oncology palliative medicine: drug compliance and patient adherence

ObjectivesMost patients in palliative oncology care are polymorbid and thus treated with multiple drugs. The therapeutic effect and safety of these drugs can be compromised by drug/drug interactions, but also...

Safety and feasibility of JAK inhibitor ruxolitinib in newly-diagnosed high-grade gliomas (CRUX): Final toxicity report.

2060 Background: Dysregulation of the JAK/STAT pathway in newly-diagnosed high-grade gliomas (nHGG) is linked to enhanced survival and proliferation of tumor cells. Ruxolitinib, a small molecule inhibitor of JAK1, JAK2, and JAK3, limits glioma growth in preclinical models. This concept was explored in a phase I trial (NCT03514069), whose final report on toxicity is presented here. Methods: This non-randomized prospective study included 60 WHO Grade 3-4 nHGG patients who received standard of care (SOC) therapy along with ruxolitinib in a 3+3 dose-escalation design; level 1 of 10 mg BID, level 2 of 15 mg BID, level 3 of 20 mg BID, level -1 of 5 mg BID. The primary study objective was the determination of the maximum tolerated dose (MTD) of ruxolitinib in combination with chemoradiation. The secondary objective was the determination of safety, overall survival (OS), and progression-free survival (PFS). The exploratory aims were to investigate relationships between clinical outcomes and genomic signatures. Results: 60 patients were enrolled, with a median age of 60.5 years (range 22-78). 23 (38%) patients were female and 37 (62%) were male. 29 (48%) were MGMT unmethylated and received ruxolitinib with radiation of 60 Gy over 6 weeks. 31 (52%) patients were MGMT methylated and received ruxolitinib with 75 mg/m2 of temozolomide (TMZ) with radiation of 60 Gy over 6 weeks. The 1-year OS rate was 77% for all GBM patients; 62% for arm 1 (unmethylated MGMT) and 93% for arm 2 (methylated MGMT). Median OS for arm 1 was 18.1 months (10.1, NA) and was not reached for arm 2. MTD for both cohorts was 20 mg BID. No dose-limiting toxicities were observed. Toxicities attributable to study medications included four grade 4 AEs including seizure, respiratory distress, somnolence, and thromboembolic event along with 14 grade 3 adverse events (AEs), including respiratory distress, seizure, gait disturbance, weakness, thrombocytopenia, cognitive disturbance, urinary retention, and meningitis. Conclusions: Ruxolitinib therapy is safe and feasible in combination with TMZ and radiation. Efficacy of ruxolitinib plus SOC appears promising compared to historical benchmarks for both MGMT methylated and MGMT unmethylated cohorts. A randomized phase 2 trial is planned. Clinical trial information: NCT03514069 .

Legume consumption in adults and risk of cardiovascular disease and type 2 diabetes: a systematic review and meta-analysis.

This study aimed to systematically review the evidence for associations between consumption of legumes and cardiovascular disease (CVD), type 2 diabetes (T2D) and their risk factors among healthy adults. We searched MEDLINE, Embase, Cochrane Central Register of Controlled Trials, and Scopus up to 16 May 2022 for ≥4 weeks long randomized (RCT) and non-randomized controlled trials and prospective cohort studies with follow-up ≥12 months, assessing legume intake (beans/lentils/peas/soybeans, excluding peanuts and legume-products/protein/powder/flour) as the intervention or exposure. Outcomes were CVD, coronary heart disease (CHD), stroke, T2D and in intervention trials only: changes in blood lipids, glycemic markers, and blood pressure. Risk of bias (RoB) was evaluated with Cochrane's RoB2, ROBINS-I, and US Department of Agriculture (USDA)'s RoB-NObS. Effect sizes were pooled using random-effects meta-analyses and expressed as relative risk or weighed mean differences with 95% confidence intervals, heterogeneity quantified as I2. The evidence was appraised according to World Cancer Research Fund's criteria. Of the 181 full-text articles assessed for eligibility, 47 were included: 31 cohort studies (2,081,432 participants with generally low legume consumption), 14 crossover RCTs (448 participants), one parallel RCT and one non-randomized trial. Meta-analyses of cohort studies were suggestive of null associations for CVD, CHD, stroke and T2D. Meta-analyses of RCTs suggested a protective effect on total cholesterol (mean difference -0.22 mmol/L), low density lipoprotein (LDL)-cholesterol (-0.19 mmol/L), fasting glucose (-0.19 mmol/L), and HOMA-IR (-0.30). Heterogeneity was high (I2 = 52% for LDL-cholesterol, >75% for others). The overall evidence for associations between consumption of legumes and risk of CVD and T2D was considered limited - no conclusion. Legume consumption was not found to influence risk of CVD and T2D in healthy adult populations with generally low legume consumption. However, protective effects on risk factors, seen in RCTs, lend some support for recommending legume consumption as part of diverse and healthy dietary patterns for prevention of CVD and T2D.

The Efficacy of Low-Dose Risperidone Treatment for Post-Surgical Delirium in Elderly Orthopedic Patients.

Background: Delirium is an acute and typically reversible failure of essential cognitive and attentional functions and is a growing public health concern, with an incidence of 20-50% in patients older than 65 after major surgery and 61% in patients undergoing hip fracture surgery. Numerous treatment strategies have been examined with no conclusive results. The purpose of this study is to assess the efficacy of a three-day low-dose risperidone treatment protocol, 0.5 mg BID, in treating delirium in elderly hospitalized orthopedic surgery department patients. Methods: This study is a prospective non-randomized study involving the senior patient population, older than 65, in an Orthopedic Surgery Department in 2019 and 2020. Delirium was diagnosed by a confusion assessment method (CAM) questionnaire. A three-day 0.5 mg risperidone BID treatment protocol was initiated following diagnosis. Patient data collected included age, gender, chronic diseases, type of surgery and anesthesia and delirium characteristics. Results: The delirium study group included 47 patients with an average age of 84.4 years (±8.6), of whom 53.2% were females. Delirium incidence was 3.7% in all patients older than 65 (1759 patients) and 9.3% in the proximal femoral fracture group. We did not correlate electrolyte imbalance, anemia, polypharmacy and chronic diseases to delirium onset characteristics. Following the three-day low-dose risperidone treatment protocol, 0.5 mg BID, 14.9% of the patients showed CAM score normalization after one day of treatment, and 93.6% within two days. Conclusions: We found our rigid three-day low-dose risperidone treatment protocol, 0.5 mg BID, efficacious in fast delirium resolution, without side effects.

Exercise prescription to patients with cardiovascular disease is in greater agreement with ESC/EAPC recommendations after using the EXPERT Training tool

Abstract Funding Acknowledgements Type of funding sources: Public grant(s) – National budget only. Main funding source(s): This work was supported by the Flemish Research Fund (FWO, FWO-ICA: G0F4220N). Background Exercise prescriptions by clinicians to patients with cardiovascular disease (CVD) often disagree with recommendations, thus requiring improvement. Aim To assess whether exercise prescriptions by clinicians to patients with CVD are better in agreement with ESC/EAPC recommendations when the EXPERT Training tool is used for digital training. Design: Prospective non-randomized intervention study. Methods Twenty-three Belgian physiotherapists first prescribed exercise intensity, frequency, session duration, program duration and exercise type (endurance or strength training) for the same three patient cases, from which the agreement with ESC/EAPC recommendations (based on a maximal score of 60/per case: agreement score) was assessed. Next, they completed a one-month digital training by using the EXPERT Training tool and completed 31±13 (out of 45 available) training cases. Thereafter, the same three patient cases as at entry of study were filled out again, with re-assessment of level of agreement with ESC/EAPC recommendations. Results After using the EXPERT Training tool the clinicians’ prescribed significantly greater exercise frequencies, program durations and total exercise volumes in all three patient cases (p&amp;lt;0.05). In case 1, 2 and 3, the agreement score increased from 29±9 (out of 60) to 41±9, from 28±9 to 41±10, and from 34±7 to 45±8, respectively (p&amp;lt;0.001). Hence, the total agreement score increased from 91±17 (out of 180) to 127±19 (p&amp;lt;0.001, +44±32%). A lower starting agreement score and younger age correlated significantly with a greater improvement in total agreement score (p&amp;lt;0.05). Conclusions Exercise prescriptions to patients with CVD, generated by clinicians, are significantly better in agreement with ESC/EAPC recommendations when the EXPERT Training tool is used.

Family History of Aortic Disease Has No Effect on Outcomes of Fenestrated-branched Endovascular Aortic Repair in Patients with Complex Aortic Aneurysms

Prior reports have indicated an increased risk of aneurysm-related complications after endovascular repair in patients with familial aortic aneurysms. The aim of this study was to evaluate outcomes of fenestrated-branched endovascular aortic repair (F-BEVAR) for the treatment of complex abdominal (CAAAs) and thoracoabdominal aortic aneurysms (TAAAs) in patients with familial history of aortic aneurysms or dissections (FAA). The clinical data of 506 consecutive patients (69% male; 74 ± 8 years old) enrolled in a prospective non-randomized study to investigate outcomes of F-BEVAR for the treatment of CAAAs and TAAAs between 2013 and 2022 was reviewed. Outcomes were analyzed in patients with FAA affecting a first or second-degree relative and compared with patients with sporadic aortic aneurysms (SAAs). Endpoints included differences in the distribution of aortic disease, procedural metrics, 30-day mortality, and major adverse events (MAEs), patient survival, and mid-term stent-graft-related outcomes. There were 68 patients (13%) with FAAs and 438 (87%) with SAAs. Both groups had similar cardiovascular risk factors, history of aortic dissection, and aneurysm extent. FAA patients had significantly (P < .05) longer fluoroscopy time (82 vs 71 minutes) and higher radiation dose (1782 vs 1210 mGy). Technical success was achieved in 94.1% of the FAA group and in 96.6% of SAA group (P = .51). Median follow-up was 19 months. There was no difference in 30-day mortality and MAEs, and long-term patient survival, freedom from aortic-related mortality, and freedom from secondary interventions. Patients with FAA had higher sac shrinkage >5mm as compared with patients with SAAs (P = .006). FB-EVAR was performed with high technical success, low mortality, and low incidence of MAEs regardless of the presence of FAAs. There was no difference in the distribution of aortic disease nor in stent graft-related outcomes.TableVariablesFAA (n = 68)SAA (n = 438)P valueAneurysm type (Crawford class)0.862 Extent I4 (8.0)23 (7.4) Extent II22 (44.0)103 (33.1) Extent III8 (16.0)47 (15.1) Infrarenal short neck0 (0.0)1 (0.2) Pararenal18 (26.5)125 (28.6)30-day mortality1 (1.5)4 (0.9)1.00030-day MAESpinal cord injury0.588 No62 (91.2)411 (94.3) Motor (able to ambulate)2 (2.9)7 (1.6) Non-ambulatory4 (5.9)18 (4.1)Myocardial infarction2 (2.9)10 (2.3)1.000Major stroke0 (0.0)3 (0.7)1.000Respiratory failure5 (7.4)12 (2.8)0.111Acute kidney injury0.016 No61 (89.7)396 (90.8) Creatinine >2 but no dialysis3 (4.4)34 (7.8) Temporary dialysis3 (4.4)2 (0.5) Permanent dialysis1 (1.5)4 (0.9)Long-term secondary intervention17 (25.4)96 (22.5)0.721Aneurysm sac behavior Stable17 (25.4)199 (47.2)0.001 Enlarged >5 mm3 (4.5)33 (7.8)0.471 Shrunk >5 mm47 (70.1)189 (44.8)<0.001Final sac diameter53.8 (14.9)59.3 (15.1)0.006FAA, Familial history of aortic aneurysms or dissections; MAE, major adverse event; SAA, sporadic aortic aneurysms.Data are presented as number (%) or mean (standard deviation).Boldface P values indicate statistical significance. Open table in a new tab

Effectiveness of Homoeopathic Medicines in the Treatment of Chronic Urticaria

Background: Chronic urticaria is occurrence of wheals more than twice a week for a period of six weeks or longer. It is a vascular reaction of the skin characterised by the appearance of wheals, which are elevated whitish reddish plaques, generally surrounded by a red halo and associated with severe itching, stinging or burning sensations. Generally the lesions increase in frequency after adolescence, with highest incidence in persons in 3rd decade of their lives. Non- sedating anti-H1 antihistamines are the mainstay of treatment; when ineffective higher dosages are tried, though all are associated with a lot of side effects ranging from arrhythmias to osteoporosis when used for a long period.&#x0D; Objectives: The aims and objectives of the present study were to understand the clinical presentation of CU and to assess the effects of constitutional homoeopathic remedies in the treatment of chronic urticaria based on the Urticaria Activity Score (UAS), and to study their effects on the quality of life of the patients before and after treatment, using the Dermatology Life Quality Index (DLQI).&#x0D; Materials and Methods: It was a prospective non-randomised uncontrolled observational study; sample size was 30; case taking of all the patients was done based on standard case taking proforma, consent was taken from each patient,a questionnaire of 22 points was used to elicit significant aspects of the nature of urticaria, all the patients were prescribed medicines depending on individual case; follow-up was done every 30 days from first prescription. At each visit, scoring of clinical symptoms was done with the help of UAS. Prognosis was made by comparing the different scores at each visit. Lastly, quality of life assessment was done before and after treatment using DLQI.&#x0D; Results: According to severity based on the Urticaria Activity Score, before treatment 10% patients were in mild category, 60% patients in moderate category and 30% in severe category. After treatment, 63.33% patients were in mild category and 36.67% in moderate category. The t-value was 10.56(p=0.001) for UAS. Based on DLQI, 6.67% were in large effect group, 63.33% in moderate effect group, 26.67% in small effect group and 3.33% in no effect group.&#x0D; &#x0D; KEYWORDS: Chronic Urticaria, Homoeopathic treatment, Urticaria Activity Score (UAS), Dermatology Life Quality Index(DLQI)&#x0D; Conflict of interest: None&#x0D; &#x0D;

Effect of Kangaroo Care Following Immersion Bath on Body Temperature in Preterm Neonates

Objectives One of the aspects of routine care in stable preterm in the ward is bathing. However, during and after bath, drop in body temperature has been observed. Providing Kangaroo Mother Care (KMC) instead of routinely covering the baby with clothes following bath helps in better thermoregulation. The purpose of this study was to compare the effectiveness of standard care and KMC following immersion bathing in stable preterm neonates in postnatal ward. Patients and Methods Prospective nonrandomized interventional study done in the postnatal ward of a tertiary referral hospital. All consecutively born preterm neonates with corrected gestational age between 34 weeks and 37 weeks (mean 35 weeks +5) were enrolled in the study. Neonates received immersion bath in a tub using water temperature adjusted to 37 to 38℃. Neonates in this group were allocated to receive standard care and KMC immediately after bath on Day 1 and Day 2, respectively. Axillary temperature was recorded before bath (baseline), immediately after bath and subsequently at 15 min, 30 min, 45 min, and 60 min after bath. Data was analyzed to compare the effect of standard care and KMC immediately after bath. Results The pre-bath mean temperature between standard care and KMC were 36.27℃ and 36.47℃, respectively. In both standard care and KMC group immediately after bath there was no fall in temperature from baseline. Mean difference from baseline temperature between standard care and KMC group at 30 min, 45 min, and 60 min were 0.2℃, 0.25℃, and 0.18℃, respectively, all of which were statistically significant ( P &lt; .05). Conclusions In this pilot study on immersion bathing followed by KMC, temperature regulation was better with KMC after bathing, with a mean temperature difference ranging between 0.18 ℃ and 0.25℃ (95% CI –0.103 to0.374) between 30 min and 60 min of bathing.

Value of prolonged scrotal drainage after penile prosthesis implantation: a multicenter prospective nonrandomized pilot study.

We aimed to understand the risks and benefits of post-inflatable penile prosthesis (IPP) implantation drainage and optimal duration. Our patients were divided into 3 groups: Group 1 (n = 114) had no drain placed, Group 2 had a drain placed for 24 h (n = 114) and Group 3 had a drain placed for 72 h (n = 117). Postoperative scrotal hematoma and prosthesis infection rates were compared between the groups. The patients from Group 3 demonstrated a statistically significant lower incidence of hematoma on the 10th postoperative day: (n = 1, 0.9%) compared to Group 2: (n = 11, 9.6%) and Group 1: (n = 8, 7%), (p = 0.013). However, on the 3rd postoperative day, there was a statistically significant lower incidence of hematoma in both Groups 3 and 2: (0.9% and 6.1%, respectively) vs. Group 1: (11.4%), (p = 0.004). Hematoma rates followed the same group order after the first day of surgery: 1.7% (n = 2), 5.3% (n = 6), and 8.8% (n = 10), respectively, (p = 0.05). Five patients (4.4%) in Group 1 and four patients (3.5%) in Group 2 developed an IPP associated infection, opposed to only a single patient (0.85%) in Group 3, (p = 0.210). We concluded that prolonged scrotal drainage for 72 h after virgin IPP implantation significantly reduces hematoma and infection rates.