Trial reportPloS one2023
Effects of low versus high inspired oxygen fraction on myocardial injury after transcatheter aortic valve implantation: A randomized clinical trial.
Trial report in PloS one, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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0 citing papers in PubMed, 1 citations in OpenAlex.
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Authors and funding
9 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundOxygen therapy is used in various clinical situation, but its clinical outcomes are inconsistent. The relationship between the fraction of inspired oxygen (FIO2) during transcatheter aortic valve implantation (TAVI) and clinical outcomes has not been well studied. We investigated the association of FIO2 (low vs. high) and myocardial injury in patients undergoing TAVI.
methodsAdults undergoing transfemoral TAVI under general anesthesia were randomly assigned to receive FIO2 0.3 or 0.8 during procedure. The primary outcome was the area under the curve (AUC) for high-sensitivity cardiac troponin I (hs-cTnI) during the first 72 h following TAVI. Secondary outcomes included the AUC for postprocedural creatine kinase-myocardial band (CK-MB), acute kidney injury and recovery, conduction abnormalities, pacemaker implantation, stroke, myocardial infarction, and in-hospital mortality.
resultsBetween October 2017 and April 2022, 72 patients were randomized and 62 were included in the final analysis (n = 31 per group). The median (IQR) AUC for hs-cTnI in the first 72 h was 42.66 (24.82-65.44) and 71.96 (35.38-116.34) h·ng/mL in the FIO2 0.3 and 0.8 groups, respectively (p = 0.066). The AUC for CK-MB in the first 72 h was 257.6 (155.6-322.0) and 342.2 (195.4-485.2) h·ng/mL in the FIO2 0.3 and 0.8 groups, respectively (p = 0.132). Acute kidney recovery, defined as an increase in the estimated glomerular filtration rate ≥ 25% of baseline in 48 h, was more common in the FIO2 0.3 group (65% vs. 39%, p = 0.042). Other clinical outcomes were comparable between the groups.
conclusionsThe FIO2 level did not have a significant effect on periprocedural myocardial injury following TAVI. However, considering the marginal results, a benefit of low FIO2 during TAVI could not be ruled out.
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