Elsevier

Heart Rhythm

Volume 9, Issue 5, May 2012, Pages 728-735
Heart Rhythm

Clinical
Devices
Incidence and predictors of short- and long-term complications in pacemaker therapy: The FOLLOWPACE study

https://doi.org/10.1016/j.hrthm.2011.12.014Get rights and content

Background

Today quantitative information about the type of complications and their incidence during long-term pacemaker (PM) follow-up is scarce.

Objective

To assess the incidence and determinants of short- and long-term complications after first pacemaker implantation for bradycardia.

Methods

A prospective multicenter cohort study (the FOLLOWPACE study) was conducted among 1517 patients receiving a PM between January 2003 and November 2007. The independent association of patient and implantation-procedure characteristics with the incidence of PM complications was analyzed using multivariable Cox regression analysis.

Results

A total of 1517 patients in 23 Dutch PM centers were followed for a mean of 5.8 years (SD 1.1), resulting in 8797 patient-years. Within 2 months, 188 (12.4%) patients developed PM complications. Male gender, age at implantation, body mass index, a history of cerebrovascular accident, congestive heart failure, use of anticoagulant drugs, and passive atrial lead fixation were independent predictors for complications within 2 months, yielding a C-index of 0.62 (95% confidence interval 0.57–0.66). Annual hospital implanting volume did not additionally contribute to the prediction of short-term complications. Thereafter, 140 (9.2%) patients experienced complications, mostly lead-related complications (n = 84). Independent predictors for long-term complications were age, body mass index, hypertension, and a dual-chamber device, yielding a C-index of 0.62 (95% confidence interval 0.57–0.67). The occurrence of a short-term PM complication was not predictive of future PM complications.

Conclusions

Complication incidence in modern pacing therapy is still substantial. Most complications occur early after PM implantation. Although various patient- and procedure-related characteristics are independent predictors for early and late complications, their ability to identify the patient at high risk is rather poor. This relatively high incidence of PM complications and their poor prediction underscores the usefulness of current guidelines for regular follow-up of patients with PM.

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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    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.

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