Effects of low versus high inspired oxygen fraction on myocardial injury after transcatheter aortic valve implantation: A randomized clinical trial

Abstract

Background Oxygen 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.

Methods Adults 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.

Results Between 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.

Conclusions The 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.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

NCT03291210

Funding Statement

The authors received no specific funding for this work.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

This randomized controlled trial was approved by the Institutional Review Board of Seoul National University Hospital (#1707-109-871, on September 11, 2017).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

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I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

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Data Availability

All relevant data are within the manuscript and its Supporting Information files.

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