High-Flow Nasal Oxygenation During Sedation for Transcatheter Aortic Valve Replacement: The HIGH-OXY-TAVR Randomised–Controlled Trial
Year: 2025
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: Background: Data on high flow nasal oxygenation (HFNO) efficacy in hypoxia prevention in transcatheter aortic valve replacement (TAVR) are conflictive. We aimed to determine the benefit of HFNO in preventing the occurrence of desaturations during TAVR. Methods: An investigator-initiated, proof of concept, single-centre, randomised, and controlled trial on 132 adult patients who were scheduled to undergo transfemoral TAVR was conducted. Patients were randomised (1:1) to HFNO (H-group) with a flow rate of 50 L min−1 and FiO2 0.6 or standard of care oxygen therapy (S-group). The primary endpoint was the number of patients with a desaturation episode (SpO2 < 93%) for >10 s during TAVR. Secondary outcomes included arterial partial pressure of oxygen (pO2) 45 min from sedation start and changes in glomerular filtration rate from baseline to 12 h post-procedure. Results: Between 23 November and 24 July, a per-protocol analysis was performed in a total of 125 patients (H-group n = 64; S- group n = 61; 49 females). The number of patients with any desaturation episode was significantly lower in the H-group [13/64 (20%, 95% CI: 12–32%)] than in the S-group [31/61 (51%, 95% CI: 39–63%), RR: 0.39 (95%CI: 0.23–0.68)]. At 45 min, mean (SD) pO2 was higher in the H-group (24(9.8) kPa vs. 16.7(7.5) kPa; p < 0.005). A significant improvement in delta median (IQR) difference on glomerular filtration rate was observed in the H-group [1.6(−1–7.9) mL min−1 1.73 m−2] with respect to the S-group [0.2(−6.1–3.1) mL min−1 1.73 m−2; p-value: 0.013]. Conclusions: This trial demonstrated that HFNO provides a better oxygenation pattern than standard oxygen therapy during TAVR. Larger studies focusing on long-term clinical outcomes are warranted to evaluate the benefit of HFNO during sedation for TAVR procedures.
Source: Journal of Clinical Medicine
DOI: 10.3390/jcm14238347
Authors: Marc Giménez-Milà, Antoni Manzano-Valls, Omar Abdul-Jawad, María José Arguis, Salvatore Brugaletta, Thiago Carnaval, Maria José Carretero, Eduardo Flores-Umanzor, Xavier Freixa, Cristina Ibañez, Stefano Italiano, Manuel López-Baamonde, Samira Martínez-Otero, Purificación Matute, Mireia Pozo, Ricard Navarro-Ripoll, Juan Manuel Perdomo, Ander Regueiro, Irene Rovira, Francisco Javier Vega, Sebastián Videla, Manel Sabaté
Institutions: Hospital Clínic de Barcelona, Consorci Institut D'Investigacions Biomediques August Pi I Sunyer, Universitat de Barcelona, Institut d'Investigació Biomédica de Bellvitge, Universitat Autònoma de Barcelona, Hospital Universitari Germans Trias i Pujol, Centro de Investigación en Red en Enfermedades Cardiovasculares, Centro de Investigación Biomédica en Red
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,137
OpenAlex ID: W4416664999