Non-fasting yields better well-being, safety in patients getting implantable device
Fasting up to 1 hour before a cardiac implantable electronic device procedure was more beneficial than fasting up to six hours before, in terms of well-being and safety, according to study results published in Europace.
“The summed preprocedural well-being score was significantly lower for the non-fasting group, which reflects more well-being in this group, which was mainly driven by significantly lower scores for hunger and tiredness in the non-fasting group,” Kerstin Bode, MD, MSc, of the department of electrophysiology at the Heart Center Leipzig at University of Leipzig in Germany, and colleagues wrote.
Researchers studied 201 patients who were undergoing a cardiac implantable electronic device (CIED) procedure from January to November 2020 in a randomized, single-blind clinical trial to observe whether fasting or non-fasting before is better for a patient’s well-being and safety.
There were 100 patients in the non-fasting group and 101 in the fasting group. The non-fasting regimen allowed solids/fluids up to 1 hour before, and the fasting regimen allowed solids up to 6 hours before and fluids up to 2 hours before.
Numeric rating scale and levels of pain
Well-being scores on a numeric rating scale of 0 to 10 and food intake-related adverse events were the coprimary outcomes. Respiratory infections that occurred 30 days after the operation and renal, hematologic and metabolic blood parameters were also investigated.
Before undergoing their procedure, patients were asked to rate several items from 0 (nonexistent) to 10 (most severe). These items included tiredness, weakness, dizziness, anxiety, hunger, thirst, mouth dryness, headache, stomachache, other pains and nausea.
The morning after the procedure, patients were asked to give more scores from 0 to 10 on postprocedural surgical-site pain at rest and during exertion, sleep quality and overall satisfaction with the group allocation.
The numbers patients responded with were used to figure out the level of pain they experienced: low was 0 to 3, moderate was 4 to 5 and severe was 6 to 10.
Patient perception of well-being
The totaled preprocedural score was significantly lower in the non-fasting group when compared with the summed score from the fasting group, and this demonstrated greater patient well-being (non-fasting: 13.1; fasting: 16.5; 95% CI of mean difference [MD], 6.35 to 0.46; P = .029). The lower score in the non-fasting group was largely due to significantly lower scores for hunger (non-fasting: 0.9; fasting: 3.1; 95% CI of MD, 2.86 to 1.42, P = .001) and tiredness (non-fasting: 1.6; fasting: 2.6; 95% CI of MD 1.68 to 0.29, P = .023).
Well-being scores that pertained to satisfaction with the procedure, sleep quality and surgical-site pain were not significantly different between groups.
There were no intraprocedural food-related adverse events reported in either group. Additionally, there were no significant differences observed in respiratory infections and renal, hematologic and metabolic blood parameters.
One of the main study limitations was that the researchers could not force the patients to eat up until their requested fasting times to compare the exact fasting times of 1 hour and 6 hours. For the non-fasting group, the average fasting time was 5.2 hours, and for the fasting group, it was 12.63 hours (P = .001).
“This study showed that a non-fasting strategy is beneficial to a fasting strategy regarding patient’s well-being and comparable in terms of safety for the CIED procedures, allowing optimized procedure scheduling with high patient satisfaction,” Bode and colleagues wrote. “Fast-CIED trial made an important step to show that a non-fasting strategy is a viable alternative to a fasting strategy in patients undergoing elective CIED surgery. However, further large-scale trials are still required to ensure maximal patients’ comfort and safety and to facilitate and maximize patient flow.”
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