High-sensitive troponinT, interleukin-8, and interleukin-6 link with post-surgery risk in infant heart surgery.

BACKGROUND: This study focuses on biomarkers in infants after open heart surgery, and examines the association of high-sensitive troponin T (hs-cTnT), interleukin-6 (IL-6), and interleukin-8 (IL-8) with postoperative acute kidney injury (AKI), ventilatory support time and need of vasoactive drugs. METHODS: Secondary exploratory study from a double-blinded clinical randomized trial (Mile-1) on 70 infants undergoing open heart surgery with cardiopulmonary bypass (CPB). In this sub-study, the entire study population was examined without considering the study drugs. The biomarkers' peak concentration (highest concentration at 2 or 6 h post-CPB) were used for statistical analyses. RESULTS: Peak IL-8, hs-cTnT, and IL-6 occurred at 2 h post-CPB for 96%, 79%, and 63% of the patients, respectively. The odds ratio of developing AKI2-3 for IL-6 > 293 pg/mL was 23.4 (95% CI 5.3;104.0), for IL-8 > 100 pg/mL it was 11.5 (3.0;44.2), and for hs-cTnT >5597 pg/mL it was 6.1 (1.5; 24.5). In more than two third of the patients with the highest peak concentrations of IL-8, IL-6, and hs-cTnT, there was a need for ventilatory support for >24 h and use of vasoactive drugs at 24 h post-CPB, while in less than one third of the patients with the lowest peak concentrations of IL-8 and hs-cTnT such requirements were observed. CONCLUSIONS: The peak biomarker concentrations and CPB-time strongly predicted AKI2-3, with IL-6 and IL-8 emerging as strongest predictors. Furthermore, our findings suggest that measuring hs-cTnT and IL-8 just 2 h post-CPB-weaning may assist in identifying infants suitable for early extubation and highlight those at risk of prolonged ventilation.

The influence of pregnancy, parity, and mode of delivery on urinary incontinence and prolapse surgery-a national register study.

BACKGROUND: The long-term effects of vaginal delivery, parity, and pregnancy on the pelvic floor remain uncertain and controversial issues. In comparison with studies using self-reported symptoms, surgical register data may offer a more valid means for evaluating the relative influence of these risk factors. OBJECTIVE: This study used data from 3 high-quality nationwide registers, namely the Swedish National Quality Register of Gynecological Surgery, the Swedish Medical Birth Register, and the Total Population Register, to evaluate the contribution of vaginal and cesarean delivery, parity, and factors not related to childbirth to the long-term risk for reconstructive urogenital surgery. STUDY DESIGN: This was a register-based linkage study among women aged ≥45 years who underwent urinary incontinence or prolapse surgery from 2010 to 2017. This surgical cohort was divided into nulliparous women, women with ≥1 cesarean deliveries only, those with ≥1 vaginal deliveries, and according to the number of births. A corresponding reference group was constructed based on women born in 1960 from the Total Population Register (n=2,309,765). The Swedish Medical Birth Register was used to determine the rate of women with cesarean and vaginal delivery and their respective parity. Absolute and relative risk were presented per 1000 women with 95% confidence intervals. Pairwise differences were analyzed with Fisher exact tests and the Mann-Whitney U test for dichotomous and continuous variables. The trend between ≥3 ordered categories of dichotomous variables was analyzed with Mantel-Haenszel statistics. RESULTS: A total of 39,617 women underwent prolapse surgery and 20,488 underwent incontinence surgery. Among women with prolapse surgery, 97.8% had ≥1 vaginal delivery, 0.4% had ≥1 cesarean delivery only, and 1.9% were nullipara. Corresponding figures for those with incontinence surgery were 93.1%, 2.6%, and 4.3%, respectively. Women with vaginal deliveries were overrepresented in the prolapse surgery (relative risk, 1.23; 95% confidence interval, 1.22-1.24; P<.001) and incontinence surgery groups (relative risk, 1.17; 95% confidence interval, 1.15-1.19; P<.001). Nulliparous and cesarean delivered women were underrepresented in the prolapse surgery (relative risk, 0.14; 95% confidence interval, 0.13-0.15 and relative risk 0.055; 95% confidence interval, 0.046-0.065; all P<.001) and incontinence surgery groups (relative risk, 0.31; 95% confidence interval, 0.29-0.33 and relative risk, 0.40; 95% confidence interval, 0.36-0.43). The absolute risk for prolapse surgery was lowest after cesarean delivery (0.09 per 1000 women; 95% confidence interval, 0.08-0.11) and differed by a factor of 23 (absolute risk, 2.11 per 1000 women; 95% confidence interval, 2.09-2.13) from that after vaginal birth. The absolute risk for prolapse and incontinence surgery increased consistently with parity after vaginal births. This trend was not observed after cesarean delivery, which is on par with that of nulliparous women. The first vaginal birth contributed the highest increase in the absolute risk for pelvic organ prolapse surgery (6-fold) and stress urinary incontinence surgery (3-fold). The second vaginal birth contributed the lowest increase in the absolute risk for pelvic organ prolapse surgery (∼1/3 of the first vaginal birth) and for stress urinary incontinence surgery (∼1/10 of the first vaginal birth). CONCLUSION: Surgery for urinary incontinence and prolapse was almost exclusively related to vaginal parity. The risk for prolapse surgery increased consistently with parity after vaginal births but not after cesarean delivery, whereas the risk associated with cesarean delivery was on par with that of nulliparous women. Thus, cesarean delivery seems to offer protection from the need for pelvic organ prolapse and stress urinary incontinence surgery later in life.

The influence of age and health status for outcomes after mid-urethral sling surgery-a nationwide register study.

INTRODUCTION AND HYPOTHESIS: The efficacy of mid-urethral sling (MUS) surgery in older women and women with a significant disease burden is limited. We aimed to determine the influence of chronological age and physical status (assessed by the American Society of Anesthesiologists Physical Status, ASA) classification on outcomes. METHODS: Cure rate, change in frequency of lower urinary tract symptoms, satisfaction, impact, and adverse events after MUS surgery were assessed in 5200 women aged 55-94 years with MUS surgery (2010-2017). Data were analysed by multivariate logistic regression and Mantel-Haenszel chi-square statistics. RESULTS: The cure rate was 64.2% (95% CI, 60.0-68.4) in the ≥ 75-year cohort compared to 88.5% (95% CI, 87.1-89.8) in the 55-64-year cohort (trend p < 0.0001). The estimated probability of cure, improvement, and satisfaction with the procedure decreased by aOR10yr = 0.51 for cure to aOR10yr = 0.59 for satisfaction (all p < 0.0001). Women with a significant health burden (ASA class 3-4) had lower cure rates and satisfaction than those without (65.5% vs. 83.7%, p < 0.0001 and 65.7% vs. 80.6%, p < 0.0001). Older age was more likely to be associated with de novo urgency (p = 0.0022) and nocturia ≥ 2 (p < 0.0001). Adverse events, readmission, and 30-day mortality rates were low. Women, irrespective of age, were equally satisfied if they experienced a decrease of at least one step in leakage frequency. CONCLUSIONS: Even if MUS surgery in older women and those with ASA class 3-4 was associated with a lower cure rate and less satisfactory outcome, a majority were satisfied provided they experienced a reduction of incontinence episodes.

Levosimendan Versus Milrinone and Release of Myocardial Biomarkers After Pediatric Cardiac Surgery: Post Hoc Analysis of Clinical Trial Data.

OBJECTIVES: We compared the effect of two inodilators, levosimendan and milrinone, on the plasma levels of myocardial injury biomarkers, that is, high-sensitivity troponin T and heart-type fatty acid binding protein, and on N-terminal prohormone of brain natriuretic peptide as a biomarker of ventricular function. We hypothesized that levosimendan could attenuate the degree of myocardial injury when compared with milrinone. DESIGN: A post hoc, nonprespecified exploratory secondary analysis of the Milrinone versus Levosimendan-1 trial (ClinicalTrials.gov Identifier: NCT02232399). SETTING: Two pediatric tertiary university hospitals. PATIENTS: Infants 1-12 months old, diagnosed with ventricular septal defect, complete atrioventricular septal defect, or Tetralogy of Fallot undergoing corrective surgery with cardiopulmonary bypass. INTERVENTIONS: Seventy patients received a loading dose of either levosimendan or milrinone at the start of cardiopulmonary bypass followed by an infusion of the respective drug, which continued for 26 hours. MEASUREMENTS AND MAIN RESULTS: Plasma levels of the three cardiac biomarkers were measured prior to the initiation of cardiopulmonary bypass and 2, 6, and 24 hours after weaning from cardiopulmonary bypass. In both groups, the levels of high-sensitivity troponin T and heart-type fatty acid binding protein were highest at 2 hours post cardiopulmonary bypass, whereas the highest level of N-terminal prohormone of brain natriuretic peptide occurred at 24 hours post cardiopulmonary bypass. There was no significant difference in the biomarkers' plasma levels between the study groups over time. Neither was there a significant difference in the postoperative peak plasma levels of the cardiac biomarkers. CONCLUSIONS: In this post hoc analysis of the MiLe-1 trial, there was no demonstrable difference in the postoperative cardiac biomarker profile of myocardial injury and ventricular function when comparing infants managed in the perioperative period with levosimendan versus milrinone.

A Multinational Cost-Consequence Analysis of a Bone Conduction Hearing Implant System-A Randomized Trial of a Conventional vs. a Less Invasive Treatment With New Abutment Technology.

Background: It is hypothesized that, for patients with hearing loss, surgically placing an implant/abutment combination whilst leaving the subcutaneous tissues intact will improve cosmetic and clinical results, increase quality of life (QoL) for the patient, and reduce medical costs. Here, incremental costs and consequences associated with soft tissue preservation surgery with a hydroxyapatite (HA)-coated abutment (test) were compared with the conventional approach, soft tissue reduction surgery with an all-titanium abutment (control). Methods: A cost-consequence analysis was performed based on data gathered over a period of 3 years in an open randomized (1:1) controlled trial (RCT) running in four European countries (The Netherlands, Spain, France, and Sweden). Subjects with conductive or mixed hearing loss or single-sided sensorineural deafness were included. Results: During the first year, in the Netherlands (NL), France (FR), and Spain (ES) a net cost saving was achieved in favor of the test intervention because of a lower cost associated with surgery time and adverse event treatments [NL €86 (CI -50.33; 219.20), FR €134 (CI -3.63; 261.30), ES €178 (CI 34.12; 97.48)]. In Sweden (SE), the HA-coated abutment was more expensive than the conventional abutment, which neutralized the cost savings and led to a negative cost (SE €-29 CI -160.27; 97.48) of the new treatment modality. After 3 years, the mean cost saving reduced to €17 (CI -191.80; 213.30) in the Netherlands, in Spain to €84.50 (CI -117.90; 289.50), and in France to €80 (CI -99.40; 248.50). The mean additional cost in Sweden increased to €-116 (CI -326.90; 68.10). The consequences in terms of the subjective audiological benefit and Health-related quality of life (HRQoL) were comparable between treatments. A trend was identified for favorable results in the test group for some consequences and statistical significance is achieved for the cosmetic outcome as assessed by the clinician. Conclusions: From this multinational cost-consequence analysis it can be discerned that health care systems can achieve a cost saving during the first year that regresses after 3 years, by implementing soft tissue preservation surgery with a HA-coated abutment in comparison to the conventional treatment. The cosmetic results are better. (sponsored by Cochlear Bone Anchored Solutions AB; Clinical and health economic evaluation with a new Baha® abutment design combined with a minimally invasive surgical technique, ClinicalTrials.gov NCT01796236).

The role of general anesthesia on traits of neurodevelopmental disorders in a Swedish cohort of twins.

BACKGROUND: The role of general anesthetics as a risk factor for possible neurodevelopmental disorders (NDDs) in humans is unresolved. The investigation of the role of anesthetics in the development of postgeneral anesthesia (anesthesia onward) NDDs has proven to be complicated, partly because of the inherent confounding in clinical cohort studies, and partly by the fact that anesthetics are only one part in the complex process of anesthesia-surgery. METHODS: Utilizing the Swedish databases Child and Adolescent Twins Study in Sweden (CATSS) and National Patient Register (NPR), we investigated twins discordant for anesthesia, born between 1997 and 2004 for traits of NDDs. We identified 68 twin pairs discordant for anesthesia and explored traits of Attention-Deficit/Hyperactivity Disorder (ADHD), Learning Disability (LD), and Autism Spectrum Disorder (ASD) in them while simultaneously taking congenital abnormalities and systemic disorders (CSDs) into account. We analyzed the possible effect of anesthesia on neurodevelopmental problems, and we analyzed the within-pair differences using conditional linear regression. RESULTS: Twins with a recorded episode of anesthesia had higher traits of NDDs than twins without; similarly twins with CSDs had higher mean scores on all traits than twins without CSDs. The within-pair analyses suggested that exposure to anesthesia was associated with higher scores of ADHD (regression coefficient 1.02 and 95% confidence intervals: 0.27-1.78) in monozygotic (MZ) twins discordant for anesthesia. This effect remained when adjusting for congenital abnormalities. DISCUSSION: Our finding that traits of ADHD were slightly associated with anesthesia in a genetically sensitive design is in need of replication and warrants further investigation. Future studies should aim to elucidate mechanisms behind this possible association (e.g. anesthetics doses, age at exposure, exposure duration).