Dataset Information

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.

SUBMITTER: Cho YJ

PROVIDER: S-EPMC10395822 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature

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Publications

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

Cho Youn Joung YJ Hyeon Cheun C Nam Karam K Lee Seohee S Ju Jae-Woo JW Kang Jeehoon J Han Jung-Kyu JK Kim Hyo-Soo HS Jeon Yunseok Y

PloS one 20230802 8

<h4>Background</h4>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.<h4>Methods</h4>Adults undergoing transfemoral TAVI under general anesthesia were randomly assigned to receive ...[more]

PMID: 37531368

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Project description:IntroductionSevere complications after transcatheter aortic valve implantation (TAVI) are rare due to increasing procedural safety. However, TAVI procedure-related haemodynamic instability and increased risk of infection may affect renal functional reserve with subsequent renal acidosis and hyperkalaemia.ObjectiveIn this study, we investigated incidence, modifiable risk factors and prognosis of acute kidney injury (AKI) and AKI complicated by hyperkalaemia, pulmonary oedema or metabolic acidosis after TAVI.MethodsIn a retrospective single-centre study, 804 consecutive patients hospitalized during 2017 and 2018 for elective TAVI were included. AKI was defined according to the 'Kidney Disease Improving Global Outcome' (KDIGO) initiative. Variables on co-morbidities, intra-/post-interventional complications and course of renal function up to 6 months after index-hospitalization were assessed. In multivariate regression analyses, risk factors for the development of AKI, complicated AKI, renal non-recovery from AKI and in-hospital mortality were determined.ResultsIncidence of AKI was 13.8% (111/804); in-hospital mortality after TAVI was 2.3%. AKI was an independent risk factor for in-hospital mortality, odds ratio (OR) 10.3 (3.4-31.6), P < 0.001, further increasing to OR = 21.8 (6.6-71.5), P < 0.001 in patients with AKI complicated by hyperkalaemia, pulmonary oedema or metabolic acidosis, n = 57/111 (51.4%). Potentially modifiable, interventional factors independently associated with complicated AKI were infection [OR = 3.20 (1.61-6.33), P = 0.001] and red blood cell transfusion [OR = 5.04 (2.67-9.52), P < 0.001]. Valve type and size, contrast volume and other intra-interventional characteristics, such as the need for tachycardial pacing, did not influence the development of AKI. Eleven of 111 (9.9%) patients did not recover from AKI, mostly affecting patients with cardiac decompensation. In 18/111 (16.2%) patients, information concerning AKI was provided in discharge letter. Within 6 months after TAVI, higher proportion of patients with AKI showed progression of pre-existing chronic kidney disease compared with patients without AKI [14/29, 48.3% versus 54/187, 28.9%, OR = 2.3 (95% confidence interval 1.0-5.1), P = 0.036].ConclusionsAKI is common and may impede patient outcome after TAVI with acute complications such as hyperkalaemia or metabolic acidosis and adverse renal function until 6 months after intervention. Our study findings may contribute to refinement of allocation of appropriate level of care in and out of hospital after TAVI.

Project description:ObjectiveTranscatheter aortic valve implantation (TAVI) procedures are increasing rapidly, but the durability of tissue valve and periprocedural complications are not satisfactory. Immune reaction to the galactose-α-1,3 galactose β-1,4-N-acetylglucosamine (α-Gal) and conventional processing protocols of cardiac xenografts lead to calcification. Next-generation TAVI needs to be made with α-Gal-free xenografts by multiple anticalcification therapies to avoid immune rejection and enhance durability, and three-dimensional (3D) printing technology to improve the procedural safety.MethodsPorcine pericardia were decellularized and immunologically modified with α-galactosidase. The pericardia were treated by space filler, crosslinked with glutaraldehyde in organic solvent, and detoxified. The sheep-specific nitinol (nickel-titanium memory alloy) wire backbone was made from a 3D-printed model for ovine aortic root. After it passed the fitting test, we manufactured a self-expandable stented valve with the porcine pericardia mounted on the customized nitinol wire-based stent. After in vitro circulation using customized silicone aortic root, we performed TAVI in 9 sheep and obtained hemodynamic, radiological, immunohistopathological, and biochemical results.ResultsThe valve functioned well, with excellent stent fitting and good coronary flow under in vitro circulation. Sheep were sequentially scheduled to be humanely killed until 238 days after TAVI. Echocardiography and cardiac catheterization demonstrated good hemodynamic status and function of the aortic valve. The xenografts were well preserved without α-Gal immune reaction or calcification based on the immunological, radiographic, microscopic, and biochemical examinations.ConclusionsWe proved preclinical safety and efficacy for next-generation α-Gal-free TAVI with multiple anticalcification therapies and 3D-printing technology. A future clinical study is warranted based on these promising preclinical results.

Dataset Information

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

Background

Methods

Results

Conclusions

Publications

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

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