Patient selection and study endpointsĪ validated Visual Analogue Scale was used to assess the severity of pain related to the CIED implant. The incidence of primary and secondary outcomes from the two trials was also obtained. 6, 7 Demographic and clinical variables were collected for all included patients. Details of inclusion and exclusion criteria for these trials have been published previously. This study included all patients from the BRUISE CONTROL-1 and 2 RCTs undergoing CIED implantation. We also sought to develop a post-operative pain prediction score. repeat CIED surgery, etc., 8 would predict the severity of post-operative pain in patients undergoing CIED surgery. We hypothesized that multiple demographic and clinical variables, such as age, sex, presence of clinically significant haematoma (CSH), de novo vs. 6, 7 These large RCTs provided an opportunity to prospectively collect information regarding post-operative pain and determine patient and procedural variables predicting pain. The BRUISE CONTROL-1 (Bridge or continue coumadin for device surgery randomized controlled trial) and BRUISE CONTROL-2 trials were large, multicentre randomized controlled trials (RCTs) conducted to evaluate the optimal peri-operative anticoagulation strategy in patients undergoing CIED implantation or replacement. 3 Understanding the factors contributing to post-operative pain after CIED implantation may help in instituting measures to mitigate this unpleasant complication. Post-operative pain after CIED implantation is associated with patient dis-satisfaction, prolongation of hospital stay, repeat emergency department visits, and emotional distress. 1 With an ageing population and increasing life expectancy, we can expect that many patients with CIEDs will have to undergo multiple device replacement procedures. The complexity of the clinical conditions of patients undergoing CIED implantation has contributed to a number of procedure-related complications that have to be dealt with by treating physicians.

Identification of risk factors associated with post-operative pain, specifically related to the cardiac implantable electronic device (CIED) population, from the BRUISE 1 and 2 randomized controlled trial.ĭevelopment of a novel post-operative pain prediction score (HeADSS score) to identify subjects at risk of severe post-operative pain following CIED implantation.Ĭardiac implantable electronic devices (CIED) are being implanted in increasing numbers worldwide for the management of rhythm disorders and congestive heart failure. An 11-point post-operative pain prediction score was developed using the data. Multivariable regression analysis found that the presence of post-operative clinically significant haematoma, de novo CIED implantation, female sex, younger age, and lower body mass index demonstrated strong and independent associations with increased post-operative pain. Multivariable regression analyses were performed to identify predictors of significant post-operative pain and to develop a pain-prediction score. Patients were asked to grade the most severe post-operative pain, average post-operative pain, and pain on the day of the first post-operative clinic. A validated Visual Analogue Scale (VAS) was used to assess the severity of pain related to CIED implant procedures. All patients from the BRUISE CONTROL-1 and 2 trials were included in this analysis.

Bruise control 2