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

Kerstin Bode, Matthias Gerhards, Michael Doering, Johannes Lucas, Jan Tijssen, Nikolaos Dagres, Sebastian Hilbert, Sergio Richter, Sotirios Nedios, Julia Lurz, Cathleen Moscoso-Luduena, Arash Arya, Alireza Sepehri Shamloo, Gerhard Hindricks

Research output: Contribution to JournalArticleAcademicpeer-review

Abstract

AIMS: Data 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 RESULTS: In 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 < 0.001; tiredness: 1.6 ± 2.3 vs. 2.6 ± 2.7, 95% CI of MD -1.68 to -0.29, P = 0.023). No intra-procedural food-related adverse events were observed. Relevant blood parameters and 30-day follow-up did not show significant differences. CONCLUSION: These results showed that a non-fasting strategy is beneficial to a fasting one regarding patient's well-being and comparable in terms of safety for CIED procedures (NCT04389697).

Original languageEnglish
Pages (from-to)1617-1626
Number of pages10
JournalEP Europace
Volume24
Issue number10
DOIs
Publication statusPublished - 13 Oct 2022

Keywords

  • Aspiration
  • Implantable cardiac defibrillator
  • Pacemaker
  • Patient-reported outcome measures
  • Pre-procedural fasting

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