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Background: Studies on health-related quality of life (HRQoL) of patients awaiting pacemaker (PM) implantation are scarce, or executed in specific patient subgroups (regarding age or specific cardiac rhythm disorders). The purpose of this study was to systematically assess the HRQoL in a large unselected cohort of patients with a conventional indication for PM therapy., Methods: Pre-PM implantation HRQoL (measured with the SF-36 questionnaire, completed at hospital admission) of 818 consecutive Dutch patients included in the FOLLOWPACE study was compared with the HRQoL in a sample of the general Dutch population, and with several cohorts of patients with other conditions. Linear regression analysis was performed to analyze determinants of this HRQoL., Results: Almost all SF-36 subscale scores were substantially and significantly lower in the PM patients compared to the general population, with P-values < 0.001 in all SF-36 subscales except for "pain" and "general health perception." In the PM patients, presence of comorbidities, gender, and age were significantly associated with the overall physical component summary score (mean 38.8 +/- 27 standard deviation) whereas the overall mental component summary score (46.8 +/- 27.0) was associated with gender and age., Conclusion: The HRQoL of patients before first PM implantation is significantly lower than that of a general population and also various other patient populations. Physicians should be aware of this unfavorable condition and keep the time interval between the diagnosis of a cardiac rhythm disorder requiring PM implantation and the implantation procedure as short as possible.

Aims: Despite an annual rise in the numbers of patients receiving their first pacemaker (PM), the risks of the implantation procedure remains unclear. The purpose of this prospective study is to estimate the incidence of in-hospital events after first PM implantation and to determine the predictors of these events., Methods and Results: Patients with conventional pacing diagnosis were included in the Dutch multicentre FOLLOWPACE PM registry that prospectively documented patients' prognosis and quality of life, and PM events after first implantation. From these registry characteristics, implantation data and in-hospital findings were analysed as potential predictors for events in a sample of 1198 patients. In 111 patients studied, at least one serious in-hospital event occurred (incidence 10.1%, 95%CI: 8.9-12.3). Six variables, i.e. a lower body mass index, presence of heart failure in medical history, main indication for implantation, vena subclavia use for venous access, active atrial lead fixation, and the implantation of a dual chamber system, were found to be independent predictors of events after first PM implantation. The overall multivariable model yielded an ROC area of 0.65 (95%CI: 0.60-0.70)., Conclusion: This large prospective multicentre study identified six variables as independent predictors for serious in-hospital events after first implantation. This may assist the implanting cardiologist and surgeon to identify patients at higher risk, during and immediately after PM implantation.

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.