Local anesthesia during S-ICD implantation gives similar post procedural pain perception as sedation

Abstract

Abstract Introduction The PRAETORIAN-DFT trial hypothesises that subcutaneous implantable cardioverter defibrillator (S-ICD) implant without defibrillation test (DFT) but with PRAETORIAN score is non-inferior to S-ICD implant with DFT with regard to first shock efficacy in spontaneous events. Various anesthesia protocols are used for S-ICD implant, ranging from local to general anesthesia. Sedation of the patient during S-ICD implantation is required because of DFT. Without the need for DFT, local anesthesia may suffice, thereby reducing the logistical burden associated with sedation and general anesthesia. However, data comparing the effects of various anesthesia methods are lacking. Purpose This prespecified analysis of the PRAETORIAN-DFT trial aims to investigate the effect of three different anesthesia methods on (post-)operative pain during S-ICD implant. Methods In the PRAETORIAN-DFT trial (NCT03495297), 965 patients were randomised to DFT (N=483) or no DFT with PRAETORIAN Score calculation (N=482). Choice of anesthesia protocol was per local routine and physician discretion and was listed as local anesthesia (LA), monitored anesthesia care (MAC) or general anesthesia (GA). Patients under LA who underwent DFT, had MAC or GA during the test. Pain scores were assessed using the Numerical Rating Scale (NRS), prior to implant (baseline) and at 1-3 hours, 5-7 hours and 1 day post implant. Mean change in NRS compared to baseline was calculated at every time point. Exact pain scores as well as mean change in NRS were compared between anesthesia methods using a Kruskal Wallis Test. Results Pre-implant pain questionnaires were completed by 97% of patients. In the complete study cohort, 149/965 (15%) of implants were performed under LA, 327/965 (34%) under MAC and 489/965 (51%) under GA. This distribution did not differ between the randomised arms (p=0.301). There was no difference in NRS or mean change compared to baseline between the groups at any time post implant. The mean change in NRS compared to baseline was highest at 5-7 hours post implant in all groups (Figure). Analysis with patients under LA and MAC or GA during DFT as independent group showed similar results. Conclusion There was no difference in pain perception after S-ICD implantation between implant under local anesthesia, MAC and general anesthesia. These results confirm that S-ICD implantation under local anesthesia is feasible and sedation may be no longer necessary if defibrillation testing becomes redundant.Mean changes in NRS compared to baseline