Outcomes after pacemaker implantation : Results of the followpace study

Abstract

Ever since the first PM implantation in The Netherlands on january the 30th 1962 by cardiologist Dr Blom, Leiden University, there has been an almost continuous yearly increase of the numbers op PMs implanted in The Netherlands. In 2006 in the Netherlands, 9765 PM’s were implanted of which 6765 were first implants. The remaining included pacemaker replacements. In 2006, a total of 12853 leads were implanted of which 11819 were used as first implantations. A pacemaker implantation is now considered a routine procedure. Pacing therapy, however, does not end after implantation. Patients with an implanted pacing device enter a lifelong path of follow-up. The FOLLOWPACE study was designed as a nation-wide prospective cohort study among patients who received a PM for the first time executed among 24 pacemaker centers in The Netherlands. The incidence of in-hospital events after first PM implantation was 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, passive atrial lead fixation, and the implantation of a dual chamber system were found to be independent predictors of these in-hospital events. We disclosed that, in general, crucial PM parameters are regularly checked and much attention is paid to the safety of cardiac pacing throughout the follow-up. Pacing stimulation and sensing thresholds as well as lead impedances and percentages of pacing remain stable over time but these values depend on the lead location, lead fixation, and pulse duration. Reprogramming of PM parameters declined during the first year after PM implantation. The majority of PM controls was carried out by a PM technician, indicating the influence of the allied professional on the quality and safety of chronic cardiac pacing. The Health related Quality of Life (HRQoL) measured just before first PM implantation was significantly lower than that of a general population. Gender, age and the presence of cardiovascular co-morbidities are clearly related to the quality of life before PM implantation. We found that the HRQoL of patients treated with a pacemaker for conventional indications improved considerably in the first year after implantation. Almost 70 % of patients considered their HRQoL much better or even completely recovered. We found that patients with extreme low or high BMI and patients with concomitant heart failure and other cardiovascular diseases were more likely to experience an events after PM implantation. Having had an in-hospital event further increased the risk for developing a PM therapy related event as well as a major non-fatal cardiac event (but not all cause mortality). Using the Vena subclavia as access point for cardiac entrance also increased the risk of a PM therapy related event.