Surgeon experience with dynamic intraligamentary stabilization does not influence risk of failure

Purpose: Studies on dynamic intraligamentary stabilization (DIS) of acute anterior cruciate ligament (ACL) ruptures reported failure rates similar to those of conventional ACL reconstruction. This study aimed to determine whether surgeon experience with DIS is associated with revision rates or patient-reported outcomes. The hypothesis was that more experienced surgeons achieved better outcomes following DIS due to substantial learning curve. Methods: The authors prospectively enrolled 110 consecutive patients that underwent DIS and evaluated them at a minimum of 2 years. The effects of independent variables (surgeon experience, gender, age, adjuvant procedures, tear location, preinjury Tegner score, time from injury to surgery, and follow-up) on four principal outcomes (revision ACL surgery, any re-operation, IKDC and Lysholm score) were analyzed using univariable and multivariable regressions. Results: From the 110 patients enrolled, 14 patients (13%) were lost to follow-up. Of the remaining 96 patients, 11 underwent revision ACL surgery, leaving 85 patients for clinical assessment at a mean of 2.2 +/- 0.4 years (range 2.0-3.8). Arthroscopic reoperations were performed in 26 (27%) patients, including 11 (11%) revision ACL surgeries. Multivariable regressions revealed: (1) no associations between the reoperation rate and the independent variables, (2) better IKDC scores for 'designer surgeons' (b = 10.7; CI 4.9-16.5; p < 0.001), higher preinjury Tegner scores (b = 2.5, CI 0.8-4.2; p = 0.005), and younger patients (b = 0.3, CI 0.0-0.6; p = 0.039), and (3) better Lysholm scores for 'designer surgeons' (b = 7.8, CI 2.8-12.8; p = 0.005) and preinjury Tegner score (b = 1.9, CI 0.5-3.4; p = 0.010). Conclusion: Surgeon experience with DIS was not associated with rates of revision ACL surgery or general re-operations. Future, larger-scaled studies are needed to confirm these findings. Patients operated by 'designer surgeons' had slightly better IKDC and Lysholm scores, which could be due to better patient selection and/or positively biased attitudes of both surgeons and patients

The HeMoVal study protocol: a prospective international multicenter cohort study to validate cerebrospinal fluid hemoglobin as a monitoring biomarker for aneurysmal subarachnoid hemorrhage related secondary brain injury.

INTRODUCTION Preclinical studies provided a strong rationale for a pathophysiological link between cell-free hemoglobin in the cerebrospinal fluid (CSF-Hb) and secondary brain injury after subarachnoid hemorrhage (SAH-SBI). In a single-center prospective observational clinical study, external ventricular drain (EVD) based CSF-Hb proved to be a promising biomarker to monitor for SAH-SBI. The primary objective of the HeMoVal study is to prospectively validate the association between EVD based CSF-Hb and SAH-SBI during the first 14 days post-SAH. Secondary objectives include the assessment of the discrimination ability of EVD based CSF-Hb for SAH-SBI and the definition of a clinically relevant range of EVD based CSF-Hb toxicity. In addition, lumbar drain (LD) based CSF-Hb will be assessed for its association with and discrimination ability for SAH-SBI. METHODS HeMoVal is a prospective international multicenter observational cohort study. Adult patients admitted with aneurysmal subarachnoid hemorrhage (aSAH) are eligible. While all patients with aSAH are included, we target a sample size of 250 patients with EVD within the first 14 day after aSAH. Epidemiologic and disease-specific baseline measures are assessed at the time of study inclusion. In patients with EVD or LD, each day during the first 14 days post-SAH, 2 ml of CSF will be sampled in the morning, followed by assessment of the patients for SAH-SBI, co-interventions, and complications in the afternoon. After 3 months, a clinical follow-up will be performed. For statistical analysis, the cohort will be stratified into an EVD, LD and full cohort. The primary analysis will quantify the strength of association between EVD based CSF-Hb and SAH-SBI in the EVD cohort based on a generalized additive model. Secondary analyses include the strength of association between LD based CSF-Hb and SAH-SBI in the LD cohort based on a generalized additive model, as well as the discrimination ability of CSF-Hb for SAH-SBI based on receiver operating characteristic (ROC) analyses. DISCUSSION We hypothesize that this study will validate the value of CSF-Hb as a biomarker to monitor for SAH-SBI. In addition, the results of this study will provide the potential base to define an intervention threshold for future studies targeting CSF-Hb toxicity after aSAH. STUDY REGISTRATION ClinicalTrials.gov Identifier NCT04998370 . Date of registration: August 10, 2021

The HeMoVal study protocol: a prospective international multicenter cohort study to validate cerebrospinal fluid hemoglobin as a monitoring biomarker for aneurysmal subarachnoid hemorrhage related secondary brain injury

Introduction: Preclinical studies provided a strong rationale for a pathophysiological link between cell-free hemoglobin in the cerebrospinal fluid (CSF-Hb) and secondary brain injury after subarachnoid hemorrhage (SAH-SBI). In a single-center prospective observational clinical study, external ventricular drain (EVD) based CSF-Hb proved to be a promising biomarker to monitor for SAH-SBI. The primary objective of the HeMoVal study is to prospectively validate the association between EVD based CSF-Hb and SAH-SBI during the first 14 days post-SAH. Secondary objectives include the assessment of the discrimination ability of EVD based CSF-Hb for SAH-SBI and the definition of a clinically relevant range of EVD based CSF-Hb toxicity. In addition, lumbar drain (LD) based CSF-Hb will be assessed for its association with and discrimination ability for SAH-SBI. Methods: HeMoVal is a prospective international multicenter observational cohort study. Adult patients admitted with aneurysmal subarachnoid hemorrhage (aSAH) are eligible. While all patients with aSAH are included, we target a sample size of 250 patients with EVD within the first 14 day after aSAH. Epidemiologic and disease-specific baseline measures are assessed at the time of study inclusion. In patients with EVD or LD, each day during the first 14 days post-SAH, 2 ml of CSF will be sampled in the morning, followed by assessment of the patients for SAH-SBI, co-interventions, and complications in the afternoon. After 3 months, a clinical follow-up will be performed. For statistical analysis, the cohort will be stratified into an EVD, LD and full cohort. The primary analysis will quantify the strength of association between EVD based CSF-Hb and SAH-SBI in the EVD cohort based on a generalized additive model. Secondary analyses include the strength of association between LD based CSF-Hb and SAH-SBI in the LD cohort based on a generalized additive model, as well as the discrimination ability of CSF-Hb for SAH-SBI based on receiver operating characteristic (ROC) analyses. Discussion: We hypothesize that this study will validate the value of CSF-Hb as a biomarker to monitor for SAH-SBI. In addition, the results of this study will provide the potential base to define an intervention threshold for future studies targeting CSF-Hb toxicity after aSAH

Finishing the euchromatic sequence of the human genome

The sequence of the human genome encodes the genetic instructions for human physiology, as well as rich information about human evolution. In 2001, the International Human Genome Sequencing Consortium reported a draft sequence of the euchromatic portion of the human genome. Since then, the international collaboration has worked to convert this draft into a genome sequence with high accuracy and nearly complete coverage. Here, we report the result of this finishing process. The current genome sequence (Build 35) contains 2.85 billion nucleotides interrupted by only 341 gaps. It covers ∼99% of the euchromatic genome and is accurate to an error rate of ∼1 event per 100,000 bases. Many of the remaining euchromatic gaps are associated with segmental duplications and will require focused work with new methods. The near-complete sequence, the first for a vertebrate, greatly improves the precision of biological analyses of the human genome including studies of gene number, birth and death. Notably, the human enome seems to encode only 20,000-25,000 protein-coding genes. The genome sequence reported here should serve as a firm foundation for biomedical research in the decades ahead

HIT im Nachwuchsfussball - Blockperiodisierung von hochintensivem Intervalltraining

Introduction: Timesaving specific endurance training is currently necessary in soccer training settings. A possible physiologic mechanism underlying adaptations to high-intensity aerobic interval training (HIT) is the increase of the total haemoglobin mass (tHbm). This study analyses the adaptations in maximal oxygen consumption (VO2max) and tHbm resulting from a HIT block. Improvements in VO2max were expected as a result of an increase in tHbm. Methods: Fourteen young soccer players were randomized allocated into an intervention (HIT, n=8) and a control (KON, n=6) group. The target intensity was 90-95% of the maximal heart rate (HRmax) and high blood lactate levels. HIT underwent 13 HIT sessions within ten days. Sessions consisted of 4 sets of 8x15/15 sec intermittent running and 4x4 min playing in a small field. KON underwent a conventional training program. Jump height (H) and power (Pmax), VO2max, running economy (RE) and blood parameters (tHbm and blood volume (BV)) were measured pre- and 2 weeks post-intervention. Results: The HIT group reached lactate levels of 6.6 ± 1.6 mmol/L and 93.4 ± 2.2% of HRmax during intermittent running and lactate levels of 6.1 ± 2.0 mmol/L and 90.9 ± 2.1% of HRmax during playing in a small field. There were no significant differences in VO2max, RE, BV and tHbm between pre- and post-intervention. Maximal blood lactate, HRmax and Pmax decreased post-intervention   (-6.4%, -3.0% and -2.4%, respectively; p < 0.05). Discussion: The lack of differences between pre- and post-intervention prevents the establishment of a relationship between tHbm and VO2max improvements. We suggest that the selected training mode did not provide stimuli high enough to improve VO2max, partly due to the increased recovery during intermittent exercise. Furthermore, the results could also have been influenced by the recovery period after the HIT block

Reinterventions after dynamic intraligamentary stabilization in primary anterior cruciate ligament repair.

BACKGROUND The goal of this study was to perform an in-depth analysis of the frequency and cause of secondary interventions subsequent to primary anterior cruciate ligament (ACL) repair with dynamic intraligamentary stabilization (DIS). METHODS Between July 2009 and June 2014, 455 patients underwent DIS treatment. The minimum follow-up was 21months (mean 28months, range 21-64months). RESULTS A total of 215 (48.2%) reinterventions were performed in 190 (42.6%) patients. One-hundred and seventy-six (39.4%) were non-revision reinterventions, and 39 (8.7%) were revision ACL reconstructions. Re-arthroscopies included 26 (5.8%) scar tissue debridements with hardware removal due to range of motion deficits, 14 (3.1%) partial meniscectomies, four (0.9%) meniscal sutures, and four (0.9%) arthroscopies due to crepitation or knee pain. Minor non-revision reinterventions performed under analgosedation consisted of 97 (21.7%) hardware removals, 20 (4.5%) hardware removals with manipulations under anesthesia, and four manipulations under anesthesia alone (0.9%). CONCLUSIONS In our study, the revision rate was within the range of published results after ACL reconstructions. In over 90% of patients, the native ACL was preserved with no need for a secondary reconstruction. Most of the non-revision reinterventions were minor and included hardware removals and manipulations under anesthesia. The re-arthroscopy rate was lower than that after ACL reconstruction with fewer secondary meniscal sutures and partial meniscectomies. Early treatment of meniscal tears may be one crucial benefit of ACL repair with DIS

Hyperoncotic human albumin solutions for intravenous fluid therapy: Effectiveness of pathogen safety and purification methods, and clinical safety

Albumin solutions derived from human plasma have demonstrated clinical benefits as intravenous fluid therapy in clinical settings such as liver disease, sepsis, intensive care, and surgery. For all plasma-derived medicinal products, there is a potential risk from pathogens, including relevant blood-borne viruses, emerging viruses, and prion proteins. To minimize the risk of transmissible infections, the production of human albumin solutions includes rigorous donor selection and plasma testing, and effective pathogen removal and inactivation methods such as fractionation and pasteurization. Compliance with international pharmacopeial standards for purity and prekallikrein activator and aluminum content is crucial, as is post-marketing pharmacovigilance for the continuous monitoring of adverse events. This review focuses on the effectiveness of manufacturing methods in the production of plasma-derived albumin, to ensure the safety of hyperoncotic solutions for volume expansion. We evaluated evidence identified through online database (PubMed) searches and from unpublished sources, on the manufacturing and pathogen safety of plasma-derived albumin solutions. The results confirmed the already established and evolving pathogen reduction capacity of the reviewed manufacturing methods. Up-to-date post-marketing pharmacovigilance data and log10 reduction factors for known and emerging pathogens during albumin production are included. Towards the goal of ever-increasing clinical safety, potential areas of improvement, such as compliance rates for the completion of donor health questionnaires, are also discussed. Taken together, the current manufacturing and pathogen reduction steps result in albumin products of greater purity than previous-generation products, with a high margin of pathogen safety against known and emerging pathogens, such as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)

Potential exposure of butterflies in protected habitats by Bt maize cultivation: a case study in Switzerland

Transgenic Bt maize can produce insecticidal Cry proteins toxic to butterflies and moths (Lepidoptera). In protected habitats near maize fields, Bt maize pollen containing the toxin can be drifted by wind onto host plants of Lepidoptera, and inadvertently harm lepidopteran larvae feeding on these host plants. For a heterogeneous, agricultural landscape in Switzerland, we investigated the butterfly community of protected habitats and their potential exposure to possible cultivation of Bt maize, recorded the densities of maize pollen deposited on a butterfly host plant, simulated the effect of different pollen dispersal ranges and Bt maize adoption rates on the exposure of protected habitats, and explored the consequences of different buffer zones around protected habitats. On average, the 49 recorded butterfly species showed a temporal overlap of larvae of 50.10% ± 30.09% with the maize pollen shedding period. Mean maize pollen density on nettles (Urtica dioica) was 6.49 ± 13.58 pollen/cm2 (range: 0–100). Most of the pollen was deposited close to maize fields less than 30 m distance, but pollen also drifted onto host plants as far as 500 m away. In simulations, protected habitats were highly exposed to Bt maize pollen deposition even at low adoption rates of Bt maize, given that maize pollen is distributed to larger distances. The conflict between species conservation and Bt maize cultivation could be minimised by establishing buffer zones around protected habitats, where non-Bt maize is grown. The results and the known sensitivities of lepidopteran larvae to Bt suggest at least 50 m–100 m broad buffer zones, and case-specific risk assessments for distances above 100 m

Dynamic intraligamentary stabilization of anterior cruciate ligament repair: hardware removal has no effect on knee laxity at 2-year follow-up.

INTRODUCTION Dynamic intraligamentary stabilization (DIS) stabilizes the knee joint during anterior cruciate ligament (ACL) healing. After 6 months, tibial hardware removal is offered to the patients if local discomfort at the implant site is present. AIM This study compared knee laxity and functional scores 2 years after DIS between patients with and without hardware removal. It is hypothesized that it does not affect ACL healing. MATERIALS AND METHODS The study retrospectively analyzed prospectively collected data from 173 patients with either hardware removal (n = 47) or no additional intervention (n = 126). Inverse probability of treatment weighting using the propensity score was applied to balance the groups for baseline characteristics. The primary outcome was the side-to-side difference in knee laxity measured with the rolimeter at manual maximum force (Δ-Lachman). Secondary outcomes were the pivot-shift test and subjective scores. RESULTS Mean age was 34 years in both groups, and female gender was 47% (hardware removal group) and 50% (control group), respectively. No significant differences were found for Δ-Lachman (p = 0.09), pivot-shift test (p = 0.41), and subjective scores (p > 0.10) two years after DIS. CONCLUSION Knee laxity 2 years after DIS in patients with tibial hardware removal and patients without hardware removal was not significantly different. The groups were also similar regarding all the assessed functional scores. This study confirms the hypothesis that the healing ACL resumes its stabilizing role, and the hardware can be removed beginning 6 months after surgery without adverse consequences for joint stability. LEVEL OF EVIDENCE Case-control study, Level III