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Effects of Low Versus High Inspired Oxygen Fraction on Myocardial Injury After Transcatheter Aortic Valve Implantation: a Randomized Clinical Trial

Youn Joung Cho, Cheun Hyeon, Karam Nam, Seohee Lee, Jae-Woo Ju, Jeehoon Kang, Jung-Kyu Han, Hyo-Soo Kim, Yunseok Jeon

Abstract

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.

Introduction

Although a fraction of inspired oxygen (FIO2) higher than that of ambient air is generally used during general anesthesia, there is continuing debate about the optimal FIO2. High oxygen tension is beneficial for reducing surgical site infection and in 2016 World Health Organization recommended that adults receive FIO2 0.8 during mechanical ventilation under general anesthesia [1]. However, a more recent systematic review found no difference in the surgical site infection rate according to the intraoperative FIO2 amount, and suggested a negative effect of high FIO2 on long-term outcomes [2]. Other investigators did not find any difference in the degree of myocardial injury between perioperative FIO2 0.3 and 0.8, and suggested that FIO2 0.8 is safe for major non-cardiac surgery [3].

Materials and method

This randomized controlled trial was approved by the Institutional Review Board of Seoul National University Hospital (#1707-109-871, on September 11, 2017) and registered at clinicaltrials.gov (NCT03291210, on September 25, 2017) before patient enrollment. The study was conducted according to the Good Clinical Practice guidelines and Declaration of Helsinki. Written informed consent was obtained from all participants, who could withdraw at any time.

Results

Patients were screened for eligibility between October 18, 2017 and April 6, 2022. Of 189 patients, 117 were excluded based on the exclusion criteria (Fig 1). After 72 patients were randomized to the FIO2 0.3 or 0.8 groups (n = 36 each) and received their assigned FIO2 without deviation from random allocation, 10 patients were excluded due to pre-procedural PaO2 <65 mmHg (n = 4), elevated pre-procedural cTnI (n = 5), or procedure cancellation (n = 1). We noted violations of the exclusion criteria (pre-procedural PaO2 <65 mmHg or elevated cardiac biomarkers) in nine patients and excluded them from the analysis. Thus, a total of 62 patients (31 per group) were included in the final analysis. We performed additional sub-analysis including five patients (n = 2 in the FIO2 0.3 group and n = 3 in the FIO2 0.8 group) who had elevated cardiac biomarkers after randomization.

Discussion

Compared to the FIO2 0.3 group, the FIO2 0.8 group showed a greater postprocedural elevation of cardiac biomarkers, albeit without statistical significance. Postprocedural AKR was more frequent in the FIO2 0.3 group. There was no difference in other periprocedural outcomes between the groups.

Conclusions

In conclusion, the FIO2 level did not have a significant effect on periprocedural myocardial injury following TAVI with general anesthesia. However, considering the marginal results, a benefit of low FIO2 during TAVI could not be ruled out.

Acknowledgments

The authors gratefully acknowledge Sun-Young Jung, a statistician, who is collaborating with our institution, for her assistance in the statistical analysis and invaluable advice and comments. We also thank to the Medical Research Collaborating Center of Seoul National University Hospital for their dedicated support and advice concerning the statistical analyses.

Citation: Cho YJ, Hyeon C, Nam K, Lee S, Ju J-W, Kang J, et al. (2023) Effects of low versus high inspired oxygen fraction on myocardial injury after transcatheter aortic valve implantation: A randomized clinical trial. PLoS ONE 18(8): e0281232. https://doi.org/10.1371/journal.pone.0281232

Editor: Mohamed R. El-Tahan, Imam Abdulrahman Bin Faisal University College of Medicine, SAUDI ARABIA

Received: January 17, 2023; Accepted: July 18, 2023; Published: August 2, 2023

Copyright: © 2023 Cho et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

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

Funding: The authors received no specific funding for this work.

Competing interests: The authors have declared that no competing interests exist.

 

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0281232#ack

 

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