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Preoperative fasting has been practiced prior to cardiac interventions such as cardiac implantable electronic device (CIED) procedures for 4-6 h since their inceptions. However, there is no data available on safety and efficacy of a non-fasting strategy for these procedures. Strict fasting restrictions may be difficult for patients to abide by, and might even be detrimental to overall patient health and recovery. According to previous studies real fasting times are much longer than 4-6h in clinical practice. Prolonged fasting can lead to patient dissatisfaction as well as affect patient health through increased trauma response or changes in patient medication. Strict fasting regulations also hinder rescheduling patients in case of sudden schedule changes or new patient arrivals . Fasting is practiced before procedures due to a fear of vomiting and aspiration, and the associated aspiration pneumonia. This was first described by Curtis Lester Mendelson as the Mendelson-syndrome in 1946. Since then, fasting protocols have been implemented with varying lengths, and have only been remedied slightly even though modern medicine has improved greatly in regards to treating complications from aspiration. CIED implantations also don’t use regular deep sedation for their procedures, but fasting is still often practiced for 6 hours prior to procedures with very little evidence to support this practice. In our investigator-driven, prospective, parallel-group, and single-arm blinded Fast-CIED trial we randomized 201 patients undergoing elective CIED implantations in a tertiary high-volume center into two groups (NCT04389697). Patients were assigned to a non-fasting strategy (100 patients, solids/fluids allowed up to 1h) or a fasting strategy (101 patients, at least 6h no solids and 2h no fluids) before the procedure and analyzed on an intention-to-treat basis. The co-primary outcomes were patients’ wellbeing scores (based on numeric rating scale, NRS 0-10) and incidence of intra-procedural food-related adverse events, including vomiting, perioperative pulmonary aspiration and emergency intubation. Renal, hematologic and metabolic blood parameters and 30-day follow-up data were gathered. The summed pre-procedural patients’ wellbeing score was significantly lower (i.e. better) in the Non-fasting group (Non-fasting: 13.1±9.6 vs. Fasting: 16.5±11.4, 95%CI of Mean Difference (MD) -6.35 - -0.46, P=0.029), which was mainly driven by significantly lower scores for hunger and tiredness in the non-fasting group (Non-fasting versus Fasting; hunger: 0.9±1.9 versus 3.1±3.2, 95% CI of MD -2.86 – -1.42, p < 0.001; tiredness: 1.6±2.3 versus 2.6±2.7, 95% CI of MD -1.68 – -0.29, P=0.023). No intra-procedural food related adverse events were observed. Relevant blood parameters and 30-day follow-up didn’t show significant differences. The study also showed that, in daily practice, fasting times for patients were longer than intended (5.20 ± 4.88 hours and 12.63 ± 6.36 hours for the non-fasting and fasting groups, respectively (P<0.001)) mainly due to standardized meal serving times in hospitals regardless of procedure starting times and short-term schedule changes. The Fast-CIED Study was the first randomized clinical trial to assess the benefits of a non-fasting compared to a fasting strategy before elective cardiac implantable electronic device (CIED) procedures. It showed that a non-fasting strategy is beneficial to a fasting strategy regarding patients’ wellbeing and comparable in terms of safety for CIED-procedures, allowing optimized procedure scheduling with high patient satisfaction. Our 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.:1. Introduction 4 1.1. Purpose of this study 4 1.2. History of preoperative fasting 5 1.3. Modern Practices 7 2. Publication 11 3. Summary/Synopsis 21 4. References 25 5. Spezifizierung des eigenen Beitrags 27 6. Erklärung über die eigenständige Abfassung der Arbeit 29 7. Lebenslauf 30 8. Danksagung 31

BACKGROUND: There are only limited data about peri-interventional pain during cardiac electrophysiological procedures without analgosedation. In this study, peri-interventional pain and recollection of it after the intervention were evaluated. METHODS: A total of 101 patients (43 electrophysiological/ablation procedures and 58 device surgeries) reported pain on a numerical rating scale (NRS; 0-10) before (pre), during (peri), and after (post) the intervention. Maximum pain (maxNRS) and the average of pain (meanNRS) were used for statistical analysis. Peri-interventional pain was compared with postinterventional data of the recollection of peri-interventional pain (peri-post). Patients were allocated into 2 groups (with 51 and 50 patients, respectively) to evaluate the mode of patient-staff interaction on pain recollection. Depressive, anxiety, and somatic symptom scales (Patient Health Questionnaire-15, Generalized Anxiety Disorder-7, and Patient Health Questionnaire-15) were used to analyze their influence on pain recollection. RESULTS: In total, 49.6% of patients (n = 50) complained of moderate to severe pain (maxNRS) at least once during the procedure. The comparison between peri and peri-post data revealed the following (median (range)-maxNRS, peri: 3 (0-10) versus peri-post: 4 (0-9) (ns), and meanNRS, peri: 1.4 (0-7) versus peri-post: 2.0 (0-6) (ns). The mode of patient-staff interaction had no influence on pain. No effect was found for psychosocial factor concerning pain and the recollection of pain. The results of the linear regression showed no influence of low-dose midazolam on recollection of pain. CONCLUSION: Half of the patients reported moderate to severe pain at least once during cardiac electrophysiological procedures without analgosedation. However, on average, patients reported only low pain levels. Postinterventional derived data on discomfort reflect the peri-interventional situation.:Inhaltsverzeichnis 1 Einführung in die Thematik 1.1 Hintergrund zur Thematik 1.2 Inhaltlicher Gegenstand 1.3 Fragestellung 2 Publikation 3 Zusammenfassung der Arbeit 4 Literatur I Darstellung des eigenen Beitrages II Selbstständigkeitserklärung III Lebenslauf IV Publikationen V Danksagung

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