DOI DOI https://doi.org/10.1007/s00392-021-01843-w
Pre-procedural fasting has been often practiced for at least 4–6 h prior to interventional cardiac procedures such as cardiac implantable electronic device (CIED) implantation since their inceptions. However, there is no data available on safety and efficacy about a non-fasting strategy in such patients.
Objective
The aim of this study is to demonstrate that in patients undergoing elective CIED procedures in daily practice, a non-fasting strategy is not inferior to a fasting strategy with respect to patient’s wellbeing and safety. Clinical Trials NCT04389697
Methods
In this non-inferiority randomized clinical trial, patients scheduled for elective CIED surgery between January and August 2020 were randomized into fasting (F; at least 6 hours no solids and 2 hours no fluids) and non-fasting (NF; solids/fluids allowed up to 1 hour before the procedure). The surgical team (nurses and doctors) was blinded to group allocation. Patient’s pre-procedural wellbeing (abdominal pain, mouth dryness, headache, anxiety, hunger, nausea, vomiting, tiredness, weakness, dizziness) and post-procedural satisfaction were evaluated with numeric rating scale (NRS 0-10). Incidence of vomiting, the need for intra-procedural emergency intubation and perioperative pulmonary aspiration were safety endpoints. Follow-up data regarding respiratory infections was gathered 30 days post-surgery. Analyses were done on an intention to treat basis.
Results
One hundred sixty three patients (71.8±11.6 years, 65.6% male) were studied. Average fasting times were 12.54±6.41 hours for the fasting arm and 5.04 ± 4.99 hours for the non-fasting arm (p<0.001). Patient wellbeing scores differed significantly only for hunger (F: NRS 3.1±3.25; NF: NRS 0.94±1.88; p<0.001) and tiredness (F: NRS 2.51±2.68 versus NF: NRS 1.66±2.39; p=0.034) between both groups. Overall satisfaction with the surgical procedure was reported as NRS 8.53±2.08 and 8.44±2.19 for the fasting and non-fasting groups (Scale 0-10, morning post-procedure), respectively (p=0.807). No incidents related to vomiting, emergency intubation or aspiration were observed in both arms. 3 patients reported respiratory infections within 30 days post-procedure; two patients (F+NF-group, respectively) with symptoms of a cold and one patient (F-group) was treated for pneumonia. Patient characteristics are summarized in Table 1.
Conclusion
Our randomized study demonstrates that non-fasting strategy for patients undergoing elective CIED surgery is not inferior to fasting. It also shows that in daily practice fasting times for patients are longer than intended due to early morning surgeries and the unpredictable nature of operating room scheduling in a high volume center. Although wellbeing was significantly reduced in the fasting group due to hunger and tiredness pre-procedure, overall satisfaction with the procedure was very high in both groups. To ensure maximal patients’ comfort and safety and to facilitate and maximize patient flow through catheterization laboratories, further research is required to provide a more evidence-based foundation on which to base future pre-procedural fasting practices.
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