Secondary Criteria Research Articles

Immunological Efficacy and Safety of a New Pneumococcal Polysaccharide Conjugated Thirteen-Valent Vaccine in the Immunization of Adults and Children (Results of Clinical Studies in the Russian Federation)

Relevance. The need to create a domestic pneumococcal polyvalent vaccine is one of the main directions of the «Strategy for the development of vaccine prevention of infectious diseases for the period up to 2035».Aim. To evaluate the immunological efficacy and safety of the pneumococcal polysaccharide conjugate adsorbed thirteen-valent (PCV13) vaccine in the immunization of adults and children in theRussian Federation.Materials and methods. The immunological efficacy and safety of the pneumococcal polysaccharide conjugated adsorbed thirteen-valent vaccine were studied in a prospective comparative randomized double-blind study in parallel groups in adult volunteers aged 18 to 65 years and a multicenter open comparative study in parallel groups in young children. In a clinical study of adults, 60 volunteers were randomized into two groups according to the 1:1 scheme (groupI, n = 30; group II, n = 30). A clinical study in children included 119 volunteers aged 15 months who were divided according to the 1:1:1 scheme (group I, n = 39; group II, n = 40; group III, n = 40). The reference vaccine in both studies is Prevenar® 13 (Pfizer Inc., USA).Results. A clinical study in adults showed no statistically significant difference between the study groups according to the results of primary (the proportion of volunteers whose concentration of serotype-specific IgG to each of the 13 pneumococcal serotypes is equal to or exceeds the level of 0.35 mcg/ml (p > 0.039) before vaccination and 4 weeks after vaccination) and secondary criteria for evaluating effectiveness. Thus, the results obtained indicate a comparable level of immunogenicity of PCV13 with the comparison drug Prevenar®13 with a single intramuscular injection to healthy volunteers aged 18–65 years. Safety in both groups was comparable, 15 local reactions were registered, including 7 in group I volunteers who received the test drug, and 8 in comparison group volunteers. There were no statistically significant differences in the frequency of registered adverse events between the groups. Similar results were obtained with the immunization of children. For all 13 serotypes of the new PCV13 in relation to the reference drug, both primary and secondary criteria for assessing immunogenicity during immunization of children have been achieved (Difference ≤ 10% and GMC and GMT Ratio ≥ 0.5, respectively), which proves no less effectiveness of the pneumococcal polysaccharide conjugated adsorbed thirteen-valent vaccine compared with the reference vaccine Prevenar® 13. During the clinical study, a total of 27 adverse events were registered in children, which were associated with the introduction of vaccines and were represented by local and systemic reactions (5 AEs in study participants from group I (5/39) 12.80%, 18 AEs in study participants from group II (18/40) 45.0% and 4 AEs in study participants from group III (4/40) 10%). No SAEs were registered in this study.Conclusion. The obtained results of the researches in children and adults allow us to recommend the preparation pneumococcal polysaccharide conjugate adsorbed thirteen-valent vaccine for immunization in order to prevent pneumococcal infection, both adults and children according to the 2+1 scheme within the National vaccination schedule and the calendar of preventive vaccinations according to epidemic indications of the Russian Federation.

Solving zero‐sum multi‐objective games with a‐priori secondary criteria

AbstractSolving non‐cooperative zero‐sum multi‐objective Games (zsMOGs), under undecided objective preferences results, for each of the players, in a Set of Rationalizable Strategies (SRS) to choose from. First, this paper deals with finding for each of the players a preferred subset of such rationalizable strategies based on a‐priori incorporation of partial preferences of the decision‐makers using secondary criteria. The obtained subset is termed the Set of Preferred Strategies (SPS). Here, a novel archive‐based co‐evolutionary algorithm is suggested to search for the SPS for each of the players. An academic example is suggested to demonstrate and validate the algorithm. It concerns a zsMOG that involves two adversarial planar manipulators. Based on a theorem that is proven here, a theoretic reference SRS is found for each of the players. This reference SRS is applied to find a reference SPS, which is used for validating the algorithm. Next, a comparison study is performed between the proposed archive‐based co‐evolutionary algorithm and an elite‐based version of this algorithm. The results clearly show that the archive‐based algorithm is superior to the elite‐based version, yielding results that correspond well to the theoretic sets.

Return to Sport After Revision ACL Reconstruction: A Comparative Cohort Study of Outcomes After Single- Versus Multiple-Revision Surgeries.

The return-to-sport rate at 2 years after multiple-revision anterior cruciate ligament (ACL) reconstructions has not been evaluated. It was hypothesized that patients who undergo multiple-revision ACL reconstructions would have a lower return-to-sport rate at 2 years after surgery than those who undergo a single-revision reconstruction. Furthermore, it was hypothesized that the multiple-revision group would have lower functional scores. Cohort study; Level of evidence, 3. A single-center cohort study in patients who underwent revision ACL reconstruction was begun in 2012. This study included 2 groups: Patients who underwent a single revision, and those who underwent multiple revisions. The main evaluation criterion was the return to sport at the 2-year follow-up. The secondary criteria were the International Knee Documentation Committee (IKDC), Knee injury and Osteoarthritis Outcome Score (KOOS), Lysholm, and ACL-Return to Sport after Injury (ACL-RSI) functional knee scores at the 1- and 2-year follow-ups. A total of 322 patients (single-revision group: n = 302; multiple-revision group: n = 20) were included. A significant difference in the percentage of patients who stopped all sports activity was found between the 2 groups at 2 years (single-revision group: 19.4%; multiple-revision group: 50%). The return-to-sport rate at the same or lower level of performance was higher in the single-revision group as well (17% vs 14.3% for return at the same level; 45.6% vs 14.3% for return at a lower level; P = .03). At the 2-year follow-up, the functional scores of the single-revision group were significantly higher those than in the multiple-revision group: IKDC (77.7 ± 13.82 vs 64.79 ± 15.22; P < .001), KOOS (72.66 ± 17.63 vs 52.5 ± 15.64; P < .001), Lysholm (84.05 ± 11.88 vs 72.5 ± 13.49; P < .001), and ACL-RSI (52.34 ± 21.83 vs 46.43 ± 14.8; P = .0036). Only a small percentage of patients returned to the same level of sport after single- revision and multiple-revision ACL reconstruction, yet significantly more in the former. More patients who underwent multiple revisions gave up their sport. Functional scores were higher for single-revision than multiple-revision surgeries.

Site selection for shared charging and swapping stations using the SECA and TRUST methods

With the increase in electric vehicle sales, the construction of charging and switching stations has caused unnecessary waste of land resources and load on the power grid, so it is necessary to consider the “centralized charging and unified distribution” model. Based on this, this paper proposes a shared charging and switching station model under the “centralized charging and unified distribution” model, in which centralized charging stations are built in suburban areas, and switching stations are built in urban areas. This model allows horizontal transfer between switching stations and establishes corresponding site selection decision guidelines. Considering that the existing charging and switching infrastructure can be converted into shared charging and switching station facilities, the MCDM (Multi-Criteria Decision Making) method is used to select sites for shared charging and switching stations. The SECA method is used to determine the weight of each secondary criterion, and the TRUST method is used to rank the alternatives. The results show that the traffic flow and the impact on the residents’ lives are important influencing factors for the location of the shared charging station, and the results show that the optimal solution is A4. Sensitivity analysis is performed by calculating the weight of each criterion or subjective assignment by different MCDM methods. The results prove that the improved method can obtain more objective optimal solutions and analyze when The results prove that the improved method can obtain more objective optimal solutions and analyze the change in solution ranking when decision-makers value different indicators.

The utility of the CADISS® system in the dissection of epidural fibrosis in revision lumbar spine surgery (A case series)

This was a prospective, open label, observational case study. We enrolled 21 patients for revision spine surgery with the CADISS® System at two Belgium sites. The primary assessment was the number of successful removals of epidural fibrosis without cutting. The amount of MESNA used, total dissection and procedure time were recorded. For secondary criterion, the surgeons assessed global satisfaction, facilitation of dissection, quickness of action, usability, bleeding reduction and visualisation of the cleavage plane using an 11-point Likert scale (0-10). Due to the exploratory nature, no formal statistical analysis was planned. We calculated the percentage and confidence interval of successful procedures, the medians and corresponding interquartile range of the Likert criterion, and the mean (±SD) of the amount of MESNA used, CADISS® dissection time and total procedure time. 24 fibrosis dissections were performed in 19 patients and 23 were successful (95.8%, CI: 78.9%; 99.9%). The mean amount of MESNA used, mean dissection time and procedure time were 16ml (±4.94), 16.5min (±16.1) and 86.3min (±25.1), respectively. No dural tears were reported. The mean global satisfaction score was 9.0 (8.0-9.0). All other Likert criterion had scores of 8.0 or 9.0, excluding quickness of action, which scored 7.0 (6.0-9.0). The CADISS® System in revision spine surgery has potential to effectively reduce dissection complications.

Awareness and Expectations of Polish Consumers Regarding Edible Niche Oils as a Food Product

Despite their nutritional value and increasing supply of oils from unconventional plants to the oil industry, edible niche oils do not have high sales. The market for niche oils is geared toward an ever-growing volume of conscious consumers distinguished by their sensitivity to product quality, packaging type, price, sourcing technology, and variety of product use. In the literature, there is a lack of research on consumer preferences and expectations of niche oils. This article continues a series of studies on niche oils aimed at determining the proper technological parameters for production, discussing the economic aspects of niche oil production, and researching consumer behavior concerning these products. It aims to determine Polish consumers’ awareness and expectations of edible niche oils, select the oils of most significant interest to consumers, and determine the factors influencing consumers’ propensity to try edible niche oils. The survey, in the form of a questionnaire, was conducted using the CAWI method on a representative sample of 1000 Polish consumers. Consumers were divided into four segments: those who regularly consume niche oils, consumers who have experience with niche oils, consumers who are familiar with them but have not tried them, and consumers who do not know niche oils. Data were analyzed collectively and separately for each segment using one-way ANOVA. Grape seed oils and edible castor oil are the most interesting to consumers. Consumers’ purchasing decisions are influenced by price, nutrient content, and sustainable production free of GMO products and harmful chemicals. Therefore, manufacturers should increase the availability of certain oils (e.g., peanut oil). Sensory qualities, place of production, and brand recognition are secondary selection criteria. Future research should focus on the organoleptic evaluation of products available on the market. Research results may be used to create production and marketing strategies to make niche oils more attractive to consumers.

Arthroscopic-assisted robotic bi-unicompartmental knee arthroplasty: a pilot cadaveric study.

Although bicondylar arthroplasty showed great functional results, it encounters some difficulties to be performed routinely. On the other hand, arthroscopic techniques tend to replace open surgical techniques in sports medicine but strive to be developed in the field of arthroplasty. This study aimed to assess the feasibility of a micro-invasive bi-compartmental knee arthroplasty using both arthroscopic and robotic technologies (A-BiUKA). The study was conducted on complete fresh-frozen and embalmed cadaveric specimens. The main criterion of judgment was the successful positioning of trial implants through a minimal quad-sparing approach. Arthroscopy was used for bone-morphing and burring, supported by an image-free robotic system. Secondary criteria of judgment were axial deviation (measured using the navigation system), operating time, and incision length. Ten A-BiUKA were performed. Implantation was successful in all cases. The mean preoperative frontal deviation was 179.8° ± 3.2 [175: 185], the mean postoperative frontal deviation was 178.5° ± 2.2 [175: 182], without any outliers. The mean correction was 1.7° ± 1.6 [0: 5]. Once the eight first A-UKA were performed, constituting the learning curve, the mean operative time for the remaining twelves surgeries was 90min ± 6. The mean skin incision length was 3.35cm ± 0.13 [3: 4]. Associated arthroscopic and robotic technologies allows to perform Bi-UKA procedure using a quad sparing mini-invasive approach. Clinical prospective studies have to confirm the feasibility and the clinical outcomes of this surgery.

Feasibility study of a self-guided internet-based intervention for family caregivers of patients with cancer (OAse)

Despite high levels of distress, family caregivers of patients with cancer rarely seek psychosocial support and Internet-based interventions (IBIs) are a promising approach to reduce some access barriers. Therefore, we developed a self-guided IBI for family caregivers of patients with cancer (OAse), which, in addition to patients' spouses, also addresses other family members (e.g., adult children, parents). This study aimed to determine the feasibility of OAse (recruitment, dropout, adherence, participant satisfaction). Secondary outcomes were caregivers’ self-efficacy, emotional state, and supportive care needs. N = 41 family caregivers participated in the study (female: 65%), mostly spouses (71%), followed by children (20%), parents (7%), and friends (2%). Recruitment (47%), retention (68%), and adherence rates (76% completed at least 4 of 6 lessons) support the feasibility of OAse. Overall, the results showed a high degree of overall participant satisfaction (96%). There were no significant pre-post differences in secondary outcome criteria, but a trend toward improvement in managing difficult interactions/emotions (p = .06) and depression/anxiety (p = .06). Although the efficacy of the intervention remains to be investigated, our results suggest that OAse can be well implemented in caregivers’ daily lives and has the potential to improve family caregivers’ coping strategies.

MISLEADING FEVERS: A CASE OF MULTISYSTEM INFLAMMATORY SYNDROME IN ADULTS DUE TO COVID-19

MISLEADING FEVERS: A CASE OF MULTISYSTEM INFLAMMATORY SYNDROME IN ADULTS DUE TO COVID-19

Walking speed at the acute and subacute stroke stage: A descriptive meta-analysis.

Gait disorders are one of the leading patient complaints at the sub-acute stroke stage (SSS) and a main determinant of disability. Walking speed (WS) is a major vital and functional index, and the Ten-Meter Walk Test is considered the gold standard after stroke. Based on a systematic review of the literature, studies published between January 2000 and November 2021 were selected when WS was reported (ten-meter walk test for short distance and/or 6-min walking distance for long distance) within 6 months following a first ischemic and/or hemorrhagic stroke (SSS) in adults prior to receiving specific walking rehabilitation. Following PRISMA guidelines, a meta-analysis was conducted on two kinds of WS: the principal criterion focused on short-distance WS (ten-meter walking test) and the secondary criteria focused on long-distance WS (6-min test) and meta-regressions to study the association of WS with balance, cognitive disorders and autonomy. Nine studies comprising a total of 939 data on post-stroke patients were selected. The weighted average age was 61 years [95% IC [55-67] and males represented 62% ± 2.7 of patients [57-67]. Average short-distance WS was 0.36 ± 0.06 m.s−1 [95% CI (0.23–0.49)]. Average long-distance WS was 0.46 ± 0.1 m.s−1 [95% CI (0.26–0.66)]. The funnel plot revealed asymmetry of publication bias and high heterogeneity of the nine studies (I2 index 98.7% and Q-test p < 0.0001). Meta-regressions of secondary endpoints could not be performed due to a lack of study data. At the SSS, WS would be lower than data in general population published in literature, but above all, lower than the WS required for safe daily autonomy and community ambulation after stroke. WS must be a priority objective of stroke rehabilitation to increase walking function but also for survival, autonomy, social participation and health-related quality of life.

Considering Proofs: Pre-Service Secondary Mathematics Teachers' Criteria for Self-Constructed and Student-Generated Arguments

In this paper, we examined 14 pre-service secondary mathematics teachers' (PSMTs) criteria used in evaluating the validity of self-constructed and student-generated arguments in the domains of algebra, geometry, and number theory. During the interviews, participants produced and analyzed their own proofs or counterexamples for the three tasks first and analyzed if six student-generated arguments could be counted as proofs next. The two criteria most frequently used by PSMTs in evaluating their own construction and a student-generated argument as a proof or not a proof were verification and clear details. Our finding showed that more PSMTs were inclined to pay attention to clear details presented in students’ work than their own productions. Our finding also showed that more PSMTs focused on the verification feature in their self-constructions than in student-generated arguments. These results suggest that the criteria–verification and clear details–do not have the same weight for PSMTs when evaluating the validity of their own work and student-generated products. This study also has implications for proof-intensive courses, as PSMTs’ conceptions of proofs are more likely affected by their instructors in those proof-intensive classes.

Early pacemaker insertion after aortic valve replacement with an Edwards Intuity sutureless valve

BackgroundPostoperative conduction disorders are serious adverse events in patients undergoing aortic valve replacement, and may prolong the duration of hospitalization and require pacemaker insertion. AimOur aim was to evaluate the rate of pacemaker insertion after implantation of an Edwards Intuity sutureless aortic valve (Edwards Lifesciences, Irvine, CA, USA) compared with a standard surgical bioprosthesis. MethodsThis retrospective single-centre study included patients who underwent aortic valve replacement with an Intuity sutureless aortic valve or a standard bioprosthetic valve between 4 June 2014 and 27 June 2016. The main outcome criterion was the rate of postoperative pacemaker insertion. Secondary outcome criteria included the rate of new conduction disorders, the rate of atrial arrhythmia or paroxysmal conduction disorders, mortality and duration of hospital stay. ResultsNinety-three patients received an Intuity sutureless aortic valve (median age 76 years, interquartile range 71–80 years), and 176 were implanted with a standard biological aortic valve (median age 73 years, interquartile range 68–79 years; P=0.007). The rate of postoperative pacemaker insertion, after adjustment, was 22.44% in the Intuity group and 5.66% in the standard aortic valve group (P=0.030). The main indications for postoperative pacemaker insertion were complete atrioventricular block and left bundle branch block with prolongation of the H-V interval. The rate of new postoperative left bundle branch block conduction disorders was significantly higher in patients implanted with an Intuity valve (odds ratio 5.28, 95% confidence interval 1.59 to 23.05; P=0.012). ConclusionHigher rates of pacemaker insertion and new conduction disorders were observed in patients implanted with an Intuity sutureless bioprosthesis compared with those who received a standard surgical aortic valve.

Separation of congenital embryonic syndactylies in children: dorsal or volar flap? About a comparative retrospective series.

Congenital syndactylies account for 1 to 2 out of 2000 birth defects. Although several types of syndactylies exist, we only studied embryonic syndactylies. The goal of our study was to compare 2 types of coverage flap for the reconstruction of the finger web spaces: a volar flap described by Blauth and a dorsal flap described by Gilbert. Between 1993 and 2015, children affected by simple and complex syndactylies (partial or complete) were treated in 2 french pediatric hospitals and were selected for our analytic, comparative, retrospective review. The 2 hospitals used different surgical techniques: one used a volar flap described by Blauth and the other a dorsal flap described by Gilbert. The children were followed up to look for signs according to the stages of the Classification of Withey and to evaluate a global result according to the score of Withey. Our secondary criteria of judgement were the aspect of the surgical scar according to the VSS (Vancouver Scar Scale) and the satisfaction of the parents and children. The age of the children, need for a surgical revision and time of last follow- up were also studied. We found statistically significant differences between group I (volar flap) and group II (dorsal flap) in favor of the volar flap: higher scores of Withey (even when the number of commissures was increasing) and better VSS (regardless of the number of web spaces treated). There was no statistically significant difference between the 2 groups in terms of age, follow-up, or rate of surgical revision. All in all, the volar flap presented less sequelae in terms of scar retraction. Regardless of the flap used, the cosmetic results of the full-thickness skin graft used impacted the result both on the receiving site (dyschromia, hairiness) and the donor site.

New classification for the treatment of pyogenic spondylodiscitis: validation study on a population of 250 patients with a follow-up of 2 years

Objective. Pyogenic spondylodiscitis (PS) is still burdened by a high rate of orthopedic and neurological complications. Despite its rising incidence, the choice of proper orthopedic treatment is often delayed by the lack of clinical data. The aim of this study was to propose a clinical-radiological classification of PS to define a standard treatment algorithm. Methods. Based on data from 250 patients treated from 2008 to 2015, a clinical-radiological classification of PS was developed. According to primary classification criteria (bone destruction or segmental instability, epidural abscesses, and neurological impairment), three main classes were identified. Subclasses were defined according to secondary criteria. PS without segmental instability or neurological impairment was treated conservatively. When significant bone loss or neurological impairment occurred, surgical stabilization and/or decompression were performed. All patients underwent clinical and radiological 2-year follow-up. Results. Type A PS occurred in 84 patients, while 46 cases were classified as type B and 120 as type C. Average time of hospitalization was 51.94 days and the overall healing rate was 92.80%. 140 patients (56.00%) were treated conservatively with average time of immobilization of 218.17 ± 9.89 days. Both VAS and SF-12 scores improved over time in all classes. Residual chronic back pain was present in 27 patients (10.80%). Overall mortality was 4.80%. Conclusions. Standardized treatment of PS is highly recommended to ensure patients a good quality of life. The proposed scheme includes all available orthopedic treatments and helps spine surgeons to significantly reduce complications and costs and avoid overtreatment.

Towards a Unified Framework for Project Success Score Computation in Construction Projects

The discussion of project success has expanded beyond project management and success criteria. The main cause of the failure to evaluate project performance in construction projects is the absence of a shared definition and a common set of criteria for project success. The aim of this paper is to develop a framework which includes certain success criteria to assess construction projects and allows for the calculation of a Project Success Score (PSS). The Rapid Impact Assessment Matrix (RIAM) approach is adopted and modified appropriately, providing a framework that combines primary and secondary success criteria to compute a comprehensive Project Success Score (PSS). Seventeen (17) success criteria are included in the framework, and their corresponding thresholds are formulated to determine the limits of failure of a project. The final PSS consists of five distinct classes, which range from the level of absolute success (PSS in the range of 9361 to 13,500) to the level of absolute failure (13 to 384). Finally, a web application that simulates the PSS framework is developed. The web application was tested by an end-user, in order to assess its applicability and ease of use, and the facilitation of the whole computation process of PSS was ensured. This paper provides a rational framework through which construction projects can be rapidly assessed, with the aim of highlighting the potential unsuccessful criteria in each project and increasing the probability of more effective project outcomes.

Comparison Between CT Volumetric Measurement and RECIST 1.1 Criteria to Assess the Tumoral Response in Advanced Renal Cell Carcinoma Treated by Immunotherapy

Objective: Assessment of a volumetric method versus gold standard unidimensional measurement based on RECIST 1.1 in advanced renal clear cell carcinoma (RCC) treated by immunotherapy. Materials and Methods: We retrospectively recorded the CT data of 14 adult patients treated with immunotherapy for metastatic RCC from February 2016 to January 2018. Follow-up CT scanners were independently reviewed by two radiologists. Unidimensional RECIST 1.1 and volumetric measurements were compared at each time point, with a total of 810 measurements performed for statistical analysis. The main criterion was the inter-observer agreement for each method. The secondary criterion was the tumoral response assessment based on three different items: RECIST 1.1, spherical volumetric method, ellipsoidal volumetric method. Results: Intraclass coefficient correlation in volumetric method (0.986 [95% CI: 0.980, 0.990]) was higher than in RECIST (0.903 [95% CI: 0.861, 0.928]). Relative measurement differences with Bland and Altman plot were lower in the volumetric method with shorter limits of agreement (0.8%; upper LOA95%: 36.5; lower LOA95%: −35), versus those in RECIST (-5.1 % (upper LOA95%: 46; lower LOA95%: −57). The volumetric method (especially the ellipsoidal one) assesses the progression disease earlier than RECIST for 57% of patients, but there is no formal difference for partial response assessment. Conclusion: Volumetric assessment for tumoral response in metastatic RCC compared to unidimensional measurements had a higher inter-observer agreement and might predict disease progression earlier.

Actual versus counterfactual fitness consequences of dispersal decisions in a cooperative breeder

In many species, dispersal from the natal group is crucial for reproduction. However, venturing into a new territory and integrating into a novel social environment is associated with risks and costs. In cooperatively breeding species, moreover, an individual’s prospects of future reproduction upon dispersal or upon remaining in the natal group might crucially depend on other group members’ concurrent decisions to disperse or to stay. We developed a methodology for evaluating how the actual decision of a potential disperser to join or not to join a dispersing individual or coalition affects its fitness in comparison with the fitness consequences it would have had if it had taken the reverse decision – to disperse instead of staying, or to stay instead of dispersing. We then examined 64 dispersal events by unisex coalitions of Arabian babblers who could not breed in their group of origin, and aimed to acquire breeding opportunities by joining another group. For each such dispersal event, we compared the fitness consequences for the members of the dispersing coalition as well as for their same-sex siblings who stayed, to the counterfactual consequences of taking the reverse decision for each of them in turn. Fitness consequences were assessed based on breeding success in the ensuing year as the leading criterion, and on social rank as a secondary criterion. We found that 69% of the dispersers and 38% of the individuals who stayed made fitness-enhancing decisions relative to the alternative they faced, and for an additional 10% of dispersers and 21% of those who stayed, their choice yielded fitness consequences on par with those of the alternative choice. These findings suggest that despite the risky and uncertain circumstances in which dispersal decisions are taken, most individuals make informed, fitness-enhancing dispersal choices, taking into account the concurrent choices of their groupmates.

Long-term outcomes of trapeziectomy with Gore-Tex® ligament reconstruction for trapezio-metacarpal osteoarthritis

BackgroundTrapezio-metacarpal osteoarthritis is a common condition for which the reference standard treatment after failure of non-operative measures is trapeziectomy. Several techniques have been devised to avoid proximal migration of the first metacarpal bone (M1) with impingement on the scaphoid bone. We have developed a Gore-Tex® ligament reconstruction technique that avoids potential complications of tendon harvesting. The objective of this study was to assess the long-term outcomes of this technique. HypothesisTrapeziectomy with Gore-Tex® ligament reconstruction is a reliable option for providing lasting pain relief in patients with trapezio-metacarpal osteoarthritis. Materials and methodsWe conducted an observational, single-centre, single-surgeon, retrospective cohort study in consecutive patients managed by primary trapeziectomy. We excluded patients with revision trapeziectomy or less than 10 years’ follow-up. The primary outcome was event-free survival, defined as absence of revision surgery and of a numerical rating scale score for pain above 3/10. The secondary criteria were clinical tolerance of the Gore-Tex® implant and radiological changes. The patients were assessed at last follow-up either in person or during a teleconsultation. ResultsOf 78 included joints, 54 were assessed during patient visits and 24 by teleconsultation. At 10 years, the event-free survival rate was 91.3%, and 60.3% of patients were free of pain. Evidence of osteolysis was visible in 24% of patients. No patient experienced clinical intolerance of the Gore-Tex® implant. The mean Disabilities of Arm, Shoulder and Hand score was 25.5. Metacarpo-phalangeal hyperextension was significantly increased, to 30.6°, and the mean trapezial space ratio was significantly decreased, to 39.1% of the baseline value. ConclusionLong-term event-free survival was high. Functional outcomes and pain were similar to previous reports. Trapeziectomy with Gore-Tex® ligament reconstruction obviates the need for tendon harvesting. Osteolysis developed in some patients but did not correlate with clinical intolerance. Long-term clinical and radiological monitoring is in order after Gore-Tex® implantation. Level of evidenceIV, Observational, single-centre, single-surgeon, retrospective cohort study.

Arterial Cannulation Simulation Training in Novice Ultrasound Users.

Arterial cannulation is an important procedure for hemodynamic monitoring and blood sampling. Traditional radial artery cannulation is performed by using anatomical knowledge and pulse palpation as a guide. Arterial cannulation using ultrasound (US) requires specific training, especially for new US users. We hypothesized that even for new US users, US guidance would facilitate the successful puncture by lower attempts before successful intraluminal cannulation of a simulation model of the radial artery. A prospective randomized controlled crossover study was conducted with new US users on a gelatin phantom wrist. Three sessions of training were proposed: US-guided technique with low blood pressure (BP), palpation-guided technique with high BP, and one secondary comparison with low BP. For the 2 first sessions, all volunteers performed each technique but not in the same order. The main criterion was the number of attempts before successful catheterization of the model artery. A secondary criterion was the number of needle movements (the number of attempts plus the number of needle directional changes). Twenty new US users participated in the study. Numbers of attempts before successful catheterization were significantly lower when using the US technique: 1.1 (± 0.4) for US versus 1.6 (± 0.8) for palpation high BP (P = .02) versus 2.5 (± 1.4) for the secondary comparison, palpation low BP (P < .001). All of the participants achieved success after the 12th needle movement for US technique, after the 19th needle movement for palpation high BP, and after the 25th needle movement for the secondary comparison, palpation low BP. The total time before success was not significantly different between the 2 first sequences (US vs palpation high BP). US technique was more successful than traditional palpation technique for novice US users performing arterial cannulations for the first time. A study in the clinical practice is needed to confirm these results.

Duct-to-duct biliary reconstruction with or without an intraductal removable stent in liver transplantation: The BILIDRAIN-T multicentric randomised trial

Background & AimsBiliary complications (BC) following liver transplantation (LT) are responsible for significant morbidity. No technical procedure during reconstruction has been associated with a risk reduction of BC. The placement of an intraductal removable stent (IRS) during reconstruction followed by its endoscopic removal showed feasibility and safety in a preliminary study. This multicentric randomised controlled trial aimed at evaluating the impact of an IRS on BC following LT.MethodsThis multicentric randomised controlled trial was conducted in 7 centres from April 2015 to February 2019. Randomisation was done during LT when a duct-to-duct anastomosis was confirmed with at least 1 of the stump diameters ≤7 mm. In the IRS group, a custom-made segment of a T-tube was placed into the bile duct to act as a stake during healing and was removed endoscopically 4 to 6 months post LT. The primary endpoint was the incidence of BC (fistulae and strictures) within 6 months post LT. The secondary criteria were complications related to the IRS placement or extraction, including endoscopic retrograde cholangio-pancreatography (ERCP)-related complications.ResultsIn total, 235 patients were randomised: 117 in the IRS group and 118 in the control group. BC occurred in 31 patients (26.5%) in the IRS group vs. 24 (20.3%) in the control group (p = 0.27), including 16 (13.8%) and 15 (12.8%) strictures, respectively. IRS migration occurred in 24 patients (20.5%), cholangitis in 1 (0.9%), acute pancreatitis in 2 (1.8%), and difficulty during endoscopic extraction in 19 (19.4%). No predictive factor for BC was identified.ConclusionsIRS does not prevent BC after LT and may require specific endoscopic expertise for removal.Trial registration number (ClinicalTrials.gov)NCT02356939 (https://clinicaltrials.gov/ct2/show/NCT02356939?term=NCT02356939&draw=2&rank=1).Lay summaryLiver transplantation is a life-saving treatment for many patients with end-stage liver disease. However, it can be associated with complications involving the bile duct reconstruction. Herein, the placement of a specific stent called an intraductal removable stent was trialled as a way of reducing bile duct complications in patients undergoing liver transplantation. Unfortunately, it did not help preventing such complications.