Long-term outcomes in contemporary bradycardia pacing: The FollowPace 2 study

Abstract

Since the introduction of the implantable cardiac pacemaker (PM) in 1958, bradycardia PM treatment has changed considerably. Both due to advancements in pacing technology, and because of a change in the profile of the mostly older PM patient, outcome data were in need of an update. This thesis provides a survey of several (long-term) outcomes of bradycardia pacing, updated to the modern era. Results are derived from the Dutch FollowPace study, which was started in 2003 and prospectively documented long-term outcomes in an unselected cohort of contemporary bradycardia PM recipients in 23 Dutch hospitals. The purpose of this study was to offer insight in the current practise and organisation of pacing in the Netherlands. We examined patient- and procedure-characteristics predictive for the different outcomes, in order to provide recommendations to improve the quality and the effectiveness of PM care. Some of the reported outcomes will be mentioned briefly. During a mean follow-up of 5.8 (SD 1.1) years, 12.4% and 9.2% of patients experienced a short- or a long-term complication of PM treatment, respectively. Although we found various independent predictors for complications, their ability to identify the patient at high risk is rather poor. Quality of life values were repeatedly measured during a 7.5 year follow-up period. Values of general health perception remained improved over pre-implantation values, showing that PM treatment impacts positively on the well-being of the device recipient. Survival rates were 93%, 81%, 69%, and 61% after 1, 3, 5, and 7 years, respectively. When cardiac disease was absent, the survival rate was equal to that of controls from the general population. This outcome suggests that the prognosis of contemporary PM recipients is mainly determined by comorbid diseases and baseline heart disease. Frequent right ventricular apical pacing is generally believed to be associated with a higher incidence of heart failure events. We evaluated the association between different levels of right ventricular pacing in relation to heart failure death, and observed a significant linear association implicating a constant increase of 9% risk of heart failure death per 10% increase in percentage right ventricular. The management and regular technical check-up of the PM recipient comprises the major component of PM care. We analysed a total of 15472 in-hospital PM check-ups. In general, the quality of PM check-up is high and important parameters of pacing were examined in the vast majority of visits. However, the frequency of check-up was often less frequent than recommended by current guidelines. The proportion of check-ups that resulted in changes in patient management declined rapidly during follow-up: from 52% in the first year after implantation to 17% in the sixth year. This observation suggests that the frequency of check-ups might be reduced after the first year after implantation. Finally, we identified several predictors for more frequent PM reprogramming, as this might compromise benefit of new remote follow-up strategies. Prediction of the patient at high risk of more frequent reprogramming was hardly possible. But because most patients (>80%) didn’t require frequent reprogramming, a potential benefit of using remote follow-up to reduce the number of unnecessary in-office visits is suggested.