Conscious sedation and analgesia use in cardiac device implantation

Cardiac device implantations are increasingly carried out using local anaesthesia (LA) with intravenous conscious sedation. The advantages include reduction of patients' anxiety and discomfort, and avoidance of risks of general anaesthesia (GA). However, concerns about the safety of sedation used without an anaesthetist have been expressed. The National Patient Safety Agency (NPSA) has identified serious problems in the use of intravenous midazolam for conscious sedation and reliance on flumazenil for reversal of over-sedation [1]. The aim of the study is to determine the safety of intravenous conscious sedation in patients undergoing cardiac device implantation and to determine patients' experience and comfort using conscious sedation. All patients undergoing device implantations (pacemaker and Cardiac Resynchronisation Therapy (CRT) implantation, elective unit replacements (EUR) andpacing leads revision) under conscious sedation were eligible. Patients with devices that were implanted under GAwere excluded. Intravenous midazolam and fentanyl could be administered alone or in combination based on operators' discretion. LA with 1% lignocaine without adrenaline was used in all patients. All data were prospectively collected. A patient questionnaire (Appendix A) was given to patients late after the procedure to allow as much time for effects of sedation towear off. A pain score of 10 reflects the worst pain possible, whereas score 1 reflects no pain. Written informed consent for the procedures was obtained. Patient participation for the questionnaire was voluntary. Verbal informed consent was obtained as per the ethics committee of the hospital. The authors of this manuscript have certified that they comply with the Principles of Ethical Publishing in the International Journal of Cardiology. The primary outcome was to determine the safety of conscious sedation administered without the presence of anaesthetist. The secondary outcome was to assess patients' satisfaction intraand postprocedure. Statistical comparisons for continuous data were performed using ANOVAs single factor, unpaired t-tests and chi-squared tests for categorical data. Logistic regression analysis was performed for multivariable predictors. All testswere two-sided and p values of a level≤0.05 were considered statistically significant.