Open Access

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

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Date: 21 June 2022
Journal: EP Europace Journal , Volume 24 , Issue 10 , Pages 1617 - 1626
Authors: K. Bode , M. Gerhards , M. Doering , J. Lucas , J. Tijssen , N. Dagres , S. Hilbert , S. Richter , S. Nedios , J. Lurz , C. Moscoso-Luduena , A. Arya , A. Shamloo , G. Hindricks

ESC Journals

AbstractAims

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).

About the contributors

Kerstin Bode

Leipzig (Heart Center Leipzig at University of Leipzig)

Role: Author

Matthias Gerhards

Role: Author

Michael Doering

Role: Author