Aims: This communication describes the design of the FOLLOWPACE study. The overall aim of FOLLOWPACE is to quantify the cost-effectiveness of routine follow-up visits in patients with a pacemaker (PM). Specific aims are (i) to quantify the incidence of complications and the quality of life 1 year after PM implantation; (ii) to quantify which baseline characteristics measured during implantation are predictors of the occurrence of complications and quality of life after 1 year; (iii) to determine the added predictive value of follow-up measurements to improve the efficiency of follow-up and to demonstrate which follow-up measurements are redundant.
Methods and results: FOLLOWPACE is a prospective, observational, prognostic cohort study. About 40 PM centres in the Netherlands will participate to include about 2,500 patients. Each patient aged >or=18 receiving a PM for the first time is eligible. At baseline, i.e. time of implantation, all potential predictors of complications and quality of life after 1 year are documented. After implantation, follow-up visits will be carried out conforming with routine care, usually three in the first year. At these visits, other potential prognostic predictors will be documented. Primary outcome is the incidence of PM- or cardiac complications at 1 year. Secondary outcome parameters are quality of life and costs after 1 year.
Conclusion: This study will lead to definition of a more efficient routine follow-up schedule for patients with a PM, aiming to reduce time and energy while preserving the safety of pacing therapy and the prognosis of the patient. The study will ultimately provide evidence-based guidelines for PM follow-up including knowledge of the responsibilities of cardiologists, technicians, and representatives of PM manufacturers.