A randomized trial of non-fasting vs. fasting for cardiac implantable electronic device procedures (Fast-CIED Study)

• Published in: Europace (London, England) England), 2022-10, Vol.24 (10), p.1617-1626
• Main Authors: Bode, Kerstin, Gerhards, Matthias, Doering, Michael, Lucas, Johannes, Tijssen, Jan, Dagres, Nikolaos, Hilbert, Sebastian, Richter, Sergio, Nedios, Sotirios, Lurz, Julia, Moscoso-Luduena, Cathleen, Arya, Arash, Shamloo, Alireza Sepehri, Hindricks, Gerhard
• Format: Article
• Language: English
• ISSN: 1099-5129; 1532-2092
• DOI: 10.1093/europace/euac081

AIMSData on safety and efficacy of a non-fasting strategy in minimal invasive cardiac procedures are lacking. We assessed a non-fasting strategy compared with a fasting strategy regarding patient's well-being and safety in elective cardiac implantable electronic device (CIED) procedures. METHODS AND RESULTSIn this randomized, single-blinded clinical trial, 201 patients (non-fasting = 100, fasting = 101) with a mean age of 72.0 ± 11.6 years (66.7% male) were assigned to a non-fasting strategy (solids/fluids allowed up to 1 h) or a fasting strategy (at least 6 h no solids and 2 h no fluids) before the procedure and analysed on an intention-to-treat basis. The co-primary outcomes were patients' well-being scores (based on numeric rating scale, 0-10) and incidence of intra-procedural food-related adverse events, including vomiting, perioperative pulmonary aspiration, and emergency intubation. Renal, haematological, and metabolic blood parameters and 30-day follow-up data were gathered. The summed pre-procedural patients' well-being score was significantly lower in the non-fasting group [non-fasting: 13.1 ± 9.6 vs. fasting: 16.5 ± 11.4, 95% confidence interval (CI) of mean difference (MD) -6.35 to -0.46, P = 0.029], which was mainly driven by significantly lower scores for hunger and tiredness in the non-fasting group (non-fasting vs. fasting; hunger: 0.9 ± 1.9 vs. 3.1 ± 3.2, 95% CI of MD -2.86 to -1.42, P