ClinicalDevicesIncidence and predictors of short- and long-term complications in pacemaker therapy: The FOLLOWPACE study
Introduction
Since 1958, cardiac pacing has become the standard therapy for symptomatic and severe bradycardia due to bradyarrhythmia and conduction disorders. Worldwide implantation rates of pacemakers (PMs) have strongly increased in the past years, particularly in the elderly people.1
Despite the impressive technological development of implantable electronic cardiac devices and a wealth of clinical experience with their application, current pacing therapy appears not to escape from complications and technical failure. Multiple studies show that the majority of complications emerge shortly after implantation.2, 3, 4, 5, 6 However, quantitative information about the type of complications and their incidence during long-term follow-up is scarce, outdated, or limited to specific device brands or patient populations.
The FOLLOWPACE study7 started in 2003 in the Netherlands and was designed to determine the incidence and predictors for short- and long-term complications after first PM implantation. The detailed successive follow-up of this prospective registry permits to identify patients at risk for adverse events. Knowledge about complications ameliorates the management of the PM recipient, specifically regarding the standard in-hospital and modern trans-telephonic follow-up. This information also supports patient counseling before and after PM implantation. Moreover, because the FOLLOWPACE study was a multicenter cohort without any prespecified intervention or pacing therapy, the data serve as a benchmark for device clinics for comparing their complication frequency.
Section snippets
Patients
The FOLLOWPACE study is a prospective multicenter cohort study conducted in 23 PM centers in the Netherlands. The design of the FOLLOWPACE study has been published previously.7, 8, 9, 10, 11 In brief, consecutive patients aged 18 years or older who received a first PM for a conventional reason for chronic pacing12 were eligible. Patients were not eligible if they were taking any investigational drug or had a nonapproved or investigational PM implanted. In addition, patients with diseases at
Results
A total of 1517 patients were included in the FOLLOWPACE study and followed for a mean of 5.8 (SD 1.1) years, resulting in a total of 8797 patient-years. Six patients were lost to follow-up: 4 because of data loss after multiple hospital transfers and 2 because of emigration abroad. Mean age at the time of first implantation was 73.7 (±10.8) years, and there were 856 (56%) men (Table 2). Main indication for PM implantation was atrioventricular conduction disturbances in 613 (40.4%), sick sinus
Discussion
This large prospective Dutch cohort study on the incidence and predictors of PM complications in conventional pacing for bradyarrhythmias observed PM complications within 2 months in 12.4% of the 1517 patients. Whereas most studies report on complications that became apparent due to their need for a repeat surgical procedure, our large cohort study permitted the collection of all adverse PM events, in relation with other patient data. During long-term follow-up for a mean of 5.8 (SD 1.1) years,
Limitations
These data result from a prospective, web-based, nationwide cohort study without any prespecified intervention in the management of the PM patient. Complications were structurally assessed during each in-hospital follow-up visit for technical checks and patient examination, therefore, the number of complications was meticulously registered. However, the amount of burden to the patient was not quantified. Another limitation is our duration of follow-up, which had a maximum of almost 8 years.
Conclusions
Despite technological advances in PM therapy, complication rates are still substantial. Although most complications occur in the initial postimplantation phase, complications during long-term follow-up are not rare but include almost 10% of the patients. Although various patient- and procedure-related characteristics are independently related to the occurrence of these PM complications, their ability to accurately identify patients at high risk is rather poor. Current guidelines on PM follow-up
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Cited by (0)
This work was supported by educational grants of all cardiac electronic device providers in the Netherlands, Biotronic Netherlands BV, Boston Scientific BV, Medtronic Netherlands BV, Sorin/ELA BV, St Jude Medical BV, The Dutch Pacemaker Registry (SPRN), Groningen, and the Heart and Lung foundation, Utrecht, The Netherlands.