| 1. |
- Wisén, Ellinor, 1978, et al.
(författare)
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Argipressin for prevention of blood loss during liver resection: a study protocol for a randomised, placebo-controlled, double-blinded trial (ARG-01)
- 2023
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Ingår i: BMJ open. - 2044-6055. ; 13:8
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Tidskriftsartikel (refereegranskat)abstract
- Liver resection carries a high risk for extensive bleeding and need for blood transfusions, which is associated with significant negative impact on outcome. In malignant disease, the most common indication for surgery, it also includes increased risk for recurrence of cancer. Argipressin decreases liver and portal blood flow and may have the potential to reduce bleeding during liver surgery, although this has not been explored.ARG-01 is a prospective, randomised, placebo-controlled, double-blinded study on 248 patients undergoing liver resection at Sahlgrenska University Hospital, Sweden. Patients will be randomised to one of two parallel groups, infusion of argipressin or normal saline administered peroperatively. The primary endpoint is peroperative blood loss. Secondary outcomes include need for blood transfusion, perioperative variables, length of hospital stay, the inflammatory response, organ damage markers and complications at 30 days.The study is enrolling patients since March 2022. The trial is approved by the Swedish Ethical Review Authority (Dnr 2021-03557) and the Swedish Medical Product Agency (Dnr 5.1-2021-90115). Results will be announced at scientific meetings and in international peer-reviewed journals.ClinicalTrials.gov, NCT05293041 and EudraCT, 2021-001806-32.
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| 2. |
- Taha, Amar, 1978, et al.
(författare)
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Cardiopulmonary bypass management and risk of new-onset atrial fibrillation after cardiac surgery.
- 2023
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Ingår i: Interdisciplinary cardiovascular and thoracic surgery. - 2753-670X. ; 37:3
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Tidskriftsartikel (refereegranskat)abstract
- Cardiopulmonary bypass management may potentially play a role in the development of new-onset atrial fibrillation after cardiac surgery. The aim of this study was to explore this potential association.Patients who underwent coronary artery bypass grafting and/or valvular surgery during 2016-2020 were included in an observational single-centre study. Data collected from the SWEDEHEART Registry, and a local Cardiopulmonary bypass database were merged. Associations between individual cardiopulmonary bypass variables (Cardiopulmonary bypass and aortic clamp times, arterial and central venous pressure, mixed venous oxygen saturation, blood flow index, bladder temperature, and haematocrit) and new-onset atrial fibrillation were analysed using multivariable logistic regression models adjusted for patient characteristics, comorbidities, and surgical procedure.Out of 1,999 patients, 758 (37.9%) developed new-onset atrial fibrillation. Patients with new-onset postoperative atrial fibrillation were older, had a higher incidence of previous stroke, worse renal function and higher EuroSCORE II and CHA2DS2-VASc scores, and more often underwent valve surgery. Longer cardiopulmonary bypass time (adjusted odds ratio (aOR) 1.05 per 10min (95% confidence interval (CI) 1.01-1.08); p=0.008) and higher flow index (aOR 1.21 per 0.2L/m2 (95% CI 1.02-1.42); p=0.026) were associated with an increased risk for new-onset atrial fibrillation, while the other variables were not. A sensitivity analysis only including patients with isolated coronary artery bypass grafting supported the primary analyses.Cardiopulmonary bypass management following current guideline recommendations appears to have minor or no influence on the risk of developing new-onset atrial fibrillation after cardiac surgery.
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| 3. |
- Barbu, Mikael, et al.
(författare)
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Hemostatic effects of a dextran-based priming solution for cardiopulmonary bypass: A secondary analysis of a randomized clinical trial
- 2023
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Ingår i: Thrombosis Research. - : Elsevier BV. - 0049-3848. ; 223, s. 139-145
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: Intravascular fluids administered to patients may influence hemostasis. In patients undergoing cardiac surgery with cardiopulmonary bypass, the heart-lung machine is primed with 1300 ml of fluid. We assessed postoperative coagulation and platelet function in patients randomized to two different priming solu-tions, one colloid-based (dextran 40) and one crystalloid-based.Materials and methods: Eighty-four elective cardiac surgery patients were randomized to either a dextran-based prime or Ringer's acetate with added mannitol. Blood samples were collected before, and 2 and 24 h after cardiopulmonary bypass. Coagulation was assessed by standard coagulation tests and rotational thromboelas-tometry. Platelet function was assessed with impedance aggregometry. Bleeding volumes and transfusion re-quirements were recorded.Results: Comparing the groups 2 h after bypass, the dextran group showed lower hemoglobin concentration, hematocrit, platelet count, and fibrinogen concentration, and higher INR and aPTT, as well as longer clot for-mation time (+41 +/- 21 % vs. +8 +/- 18 %, p < 0.001) and a larger reduction in fibrinogen-dependent clot strength (-37 +/- 12 % vs.-7 +/- 20 %, p < 0.001). Adenosine diphosphate-dependent platelet activation was reduced in the dextran group but not in the crystalloid group 2 h after bypass (-14 +/- 29 % vs.-1 +/- 41 %, p = 0.041). No significant between-group differences in hemostatic variables remained after 24 h, and no significant differences in perioperative bleeding volumes, re-explorations for bleeding, or transfusion rates were observed.Conclusions: Compared to a crystalloid solution, a dextran-based prime had measurable negative impact on he-mostatic variables but no detectable increase in bleeding volume or transfusion requirements in cardiac surgery patients.
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| 4. |
- Björklund, Erik, et al.
(författare)
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Postdischarge major bleeding, myocardial infarction, and mortality risk after coronary artery bypass grafting
- 2023
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Ingår i: HEART. - 1355-6037 .- 1468-201X.
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Tidskriftsartikel (refereegranskat)abstract
- Objective To investigate the incidence and mortality risk associated with postdischarge major bleeding after coronary artery bypass grafting (CABG), and relate this to the incidence of, and mortality risk from, postdischarge myocardial infarction.Methods All patients undergoing first-time isolated CABG in Sweden in 2006-2017 and surviving 14 days after hospital discharge were included in a cohort study. Individual patient data from the SWEDEHEART Registry and five other mandatory nationwide registries were merged. Piecewise Cox proportional hazards models were used to investigate associations between major bleeding, defined as hospitalisation for bleeding, with subsequent mortality risk. Similar Cox proportional hazards models were used to investigate the association between postdischarge myocardial infarction and mortality risk.Results Among 36 633 patients, 2429 (6.6%) had a major bleeding event and 2231 (6.1%) had a myocardial infarction. Median follow-up was 6.0 (range 0-11) years. Major bleeding was associated with higher mortality risk <30 days (adjusted HR (aHR)=20.2 (95% CI 17.3 to 23.5)), 30-365 days (aHR=3.8 (95% CI 3.4 to 4.3)) and >365 days (aHR=1.8 (95% CI 1.7 to 2.0)) after the event. Myocardial infarction was associated with higher mortality risk <30 days (aHR=20.0 (95% CI 16.7 to 23.8)), 30-365 days (aHR=4.1 (95% CI 3.6 to 4.8)) and >365 days (aHR=1.8 (95% CI 1.7 to 2.0)) after the event.Conclusions The increase in mortality risk associated with a postdischarge major bleeding after CABG is substantial and is similar to the mortality risk associated with a postdischarge myocardial infarction.
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| 5. |
- Fekete, Boglarka, et al.
(författare)
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What predicts survival in glioblastoma? A population-based study of changes in clinical management and outcome.
- 2023
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Ingår i: Frontiers in surgery. - 2296-875X. ; 10
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Tidskriftsartikel (refereegranskat)abstract
- Glioblastoma is the most common and most aggressive primary brain tumor in adults. Despite multimodal treatment, the median survival time is 15-16 months and 5-year survival rate 5%-10%. The primary goal of this study was to identify prognostic factors for survival in an unselected population of patients operated for glioblastoma. The secondary goal was to explore changes in outcome and the clinical management of this patient group over time.We identified 222 consecutive adults operated for glioblastoma between November 2012 and June 2016 at the Department of Neurosurgery, Sahlgrenska University Hospital in Gothenburg, serving a health care region in the western part of Sweden with 1.900.000 inhabitants. Clinical variables were identified and tested as predictors for prognosis in extended Poisson regression models. The results were compared with a previously published cohort from 2004 to 2008, before current standard of care based on molecular tumor diagnosis was fully implemented.Median overall survival was 1.07 years, which was significantly longer than in the 2004-2008 cohort (1.07 vs. 0.73 y, age- and sex adjusted HR=1.89, p<0.0001). Variables associated with longer survival in the multivariable model were MGMT promoter hypermethylation, non-central tumor location, complete resection of enhancing tumor, WHO performance status 0-1, unilateral tumor location, fewer lobes involved, younger age and no comorbidities.The median survival for patients with glioblastoma treated according to current standard treatment has moderately but significantly increased, with MGMT promoter hypermethylation as the strongest predictor for survival.
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| 6. |
- Fu, Michael, 1963, et al.
(författare)
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Real-world comparative effectiveness of ARNI versus ACEi/ARB in HF with reduced or mildly reduced ejection fraction.
- 2023
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Ingår i: Clinical research in cardiology : official journal of the German Cardiac Society. - : Springer Science and Business Media LLC. - 1861-0684 .- 1861-0692. ; 112:1, s. 167-174
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Tidskriftsartikel (refereegranskat)abstract
- Sacubitril/valsartan is a first-in-class angiotensin receptor-neprilysin inhibitor (ARNI) with a class-1 guideline recommendation. We assessed the real-world effectiveness of ARNI versus angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (ACEi/ARB) on all-cause and cardiovascular (CV)-related mortality and hospitalizations in heart failure (HF) with reduced or mildly reduced ejection fraction (EF).Patient-level clinical, laboratory, drug dispensation, hospitalization, and mortality data were derived from the Swedish Heart Failure Registry (SwedeHF) and interlinked databases (1 April 2016-31 December 2020). Eligible ARNI:ACEi/ARB patients (n=7275:24,604) had a left ventricular EF<50%. Mortality and hospitalizations with ARNI (≤3months pre-/post-1 April 2016 index [SwedeHF]; n=1506) versus ACEi/ARB (≤3months post-index; n=17,108) were assessed using propensity score matching (1:1 ratio) with clinical variables, and sensitivity analysis (1:2/1:3 with, and 1:2 without clinical variables).ARNI induced a 23% reduction in all-cause mortality versus ACEi/ARB (1:1 hazard ratio [HR; 95% confidence interval(CI)]: 0.77 [0.63-0.95], p=0.013), and a non-significant 23% relative risk reduction in CV-related mortality (0.77 [0.54-1.09], p=0.13), but no difference in all-cause or CV-related hospitalization (1.02 [0.91-1.13]; p=0.76; 1.01 [0.91-1.15]; p=0.84, respectively). Sensitivity analyses confirmed all-cause mortality was reduced for ARNI versus ACEi/ARB (HR0.90 [95% CI 0.82-0.99], p=0.026), but not CV-related mortality (HR1.04 [95% CI 0.89-1.22], p=0.63).In this nationwide real-world study including a population of patients with HF with reduced or mildly reduced EF, ARNI as part of guideline-led Swedish clinical practice was associated with a statistically significant relative risk reduction in all-cause mortality compared with ACEi/ARB.
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| 7. |
- Fu, Zhongjie, et al.
(författare)
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FGF21 via mitochondrial lipid oxidation promotes physiological vascularization in a mouse model of Phase I ROP
- 2023
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Ingår i: Angiogenesis. - : Springer Science and Business Media LLC. - 0969-6970 .- 1573-7209. ; 26:3, s. 409-21
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Tidskriftsartikel (refereegranskat)abstract
- Hyperglycemia in early postnatal life of preterm infants with incompletely vascularized retinas is associated with increased risk of potentially blinding neovascular retinopathy of prematurity (ROP). Neovascular ROP (Phase II ROP) is a compensatory but ultimately pathological response to the suppression of physiological postnatal retinal vascular development (Phase I ROP). Hyperglycemia in neonatal mice which suppresses physiological retinal vascular growth is associated with decreased expression of systemic and retinal fibroblast growth factor 21 (FGF21). FGF21 administration promoted and FGF21 deficiency suppressed the physiological retinal vessel growth. FGF21 increased serum adiponectin (APN) levels and loss of APN abolished FGF21 promotion of physiological retinal vascular development. Blocking mitochondrial fatty acid oxidation also abolished FGF21 protection against delayed physiological retinal vessel growth. Clinically, preterm infants developing severe neovascular ROP (versus non-severe ROP) had a lower total lipid intake with more parenteral and less enteral during the first 4weeks of life. Our data suggest that increasing FGF21 levels in the presence of adequate enteral lipids may help prevent Phase I retinopathy (and therefore prevent neovascular disease).
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| 8. |
- Harman, J. C., et al.
(författare)
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Postnatal hyperglycemia alters amino acid in retinas (model of Phase I ROP)
- 2023
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Ingår i: Iscience. ; 26:10
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Tidskriftsartikel (refereegranskat)abstract
- Nutritional deprivation occurring in most preterm infants postnatally can induce hyperglycemia, a significant and independent risk factor for suppressing physiological retinal vascularization (Phase I retinopathy of prematurity (ROP)), leading to compensatory but pathological neovascularization. Amino acid supplementation reduces retinal neovascularization in mice. Little is known about amino acid contribution to Phase I ROP. In mice modeling hyperglycemia-associated Phase I ROP, we found significant changes in retinal amino acids (including most decreased L-leucine, L-isoleucine, and L-valine). Parenteral L-isoleucine suppressed physiological retinal vascularization. In premature infants, severe ROP was associated with a higher mean intake of parenteral versus enteral amino acids in the first two weeks of life after adjustment for treatment group, gestational age at birth, birth weight, and sex. The number of days with parenteral amino acids support independently predicted severe ROP. Further understanding and modulating amino acids may help improve nutritional intervention and prevent Phase I ROP.
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| 9. |
- Lundgren, Pia, 1967, et al.
(författare)
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Visual outcome at 2.5 years of age in ω-3 and ω-6 long-chain polyunsaturated fatty acid supplemented preterm infants: a follow-up of a randomized controlled trial
- 2023
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Ingår i: Lancet Regional Health-Europe. - 2666-7762. ; 32
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Tidskriftsartikel (refereegranskat)abstract
- Background We investigated ophthalmological outcomes at 2.5 years of corrected age in children born extremely preterm (EPT) to evaluate the effects of postnatal enteral supplementation with omega-3 and omega-6 long-chain polyunsaturated fatty acids.Methods In the Mega Donna Mega clinical trial, EPT infants born at less than 28 weeks of gestation were randomized to receive an enteral supplementation of docosahexaenoic acid (DHA) and arachidonic acid (AA) from birth to 40 weeks postmenstrual age. In this exploratory follow-up at 2.5 years of corrected age, we assessed visual acuity (VA), refraction, manifest strabismus, and nystagmus. Satisfactory VA was defined as >= 20/63. Multiple imputation (MI) was used to address the issue of missing data.Findings Of 178 children in the trial, 115 (with median gestational age (GA) of 25 + 4/7 weeks and median birth weights of 790 g) were ophthalmologically assessed at a median corrected age of 2.7 years (range 2.0-3.9 years). VA assessment was missing in 42.1% (75/178), in 41.7% (35/84) of the AA/DHA supplemented infants, and in 42.6% (40/94) of the control infants. After MI and adjustments for GA, study center, plurality, and corrected age at VA exam, no significant effect of AA/DHA supplementation was detected in VA outcome (>= 20/63) (odds ratio 2.16, confidence interval 95% 0.99-4.69, p = 0.053).Interpretation In this randomized controlled trial follow-up, postnatal supplementation with enteral AA/DHA to EPT children did not significantly alter VA at 2.5 years of corrected age. Due to the high loss to follow-up rate and the limited statistical power, additional studies are needed.
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| 10. |
- Pivodic, Aldina, 1978
(författare)
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DIGIROP prediction models for severe retinopathy of prematurity
- 2023
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- BACKGROUND: Retinopathy of prematurity (ROP), a preventable, potentially blinding eye disease, is primarily diagnosed in extremely preterm infants. Gestational age (GA) and birth weight (BW) are the most prominent risk factors. Routine ROP examinations are performed to identify the low proportion of infants who progress to needing treatment. In Sweden, ~30% of all screened infants are diagnosed with ROP, and 6% require treatment. Safe ROP prediction models can improve infant well-being and make screening efficient by identifying low- and high-risk infants. AIM: The overall aim of the thesis was to develop and validate prediction models for severe ROP requiring treatment and propose a clinical decision support tool for safe and effective release of low-risk infants from ROP screening examinations. In addition, the natural course of the disease was described, and the prognostic value of the parenteral nutrition duration (PND) on ROP was demonstrated. MATERIALS AND METHODS: The model development data originated from the Swedish national ROP register (SWEDROP). External validations included data from SWEDROP, Germany, and the US. Paper I included 6947 infants in the model development and 2122 in the external validation cohort. Corresponding figures for Paper II were 6991 and 1241, and for Paper IV, 8814 and 2325, respectively. Paper III included 1082 infants in its external validation. Extended Poisson models were used to develop DIGIROP-Birth requiring GA, BW, and sex in version 1.0, and PND ≥14 days in version 2.0 as input variables. Logistic regression models were used to develop DIGIROP-Screen, including the status and the age at the first ROP diagnosis besides DIGIROP-Birth risk estimates. GA-specific cut-offs were identified for the clinical decision support tool. RESULTS: The instantaneous risk for ROP peaked around 12 weeks postnatal age, irrespective of GA at birth. Longer PND was strongly correlated to ROP severity, and faster progression. The risk for ROP differed for boys and girls over GA and PND. DIGIROP models released ~50% of infants from all ROP screening examinations and additionally ~25% during the screening process, while maintaining 100% sensitivity. CONCLUSION: DIGIROP models may safely and efficiently release infants from unnecessary ROP examinations. The models appear superior to other currently available ROP models and are freely available as an online application (www.digirop.com).
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