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Cardiac implantable electronic devices: Long-term complications

Leonard I Ganz, MD, FHRS, FACC
Section Editor
Jonathan Piccini, MD, MHS, FACC, FAHA, FHRS
Deputy Editor
Brian C Downey, MD, FACC


As more people are living longer with more medical comorbidities including significant cardiac disease, the number of permanent pacemakers (PPMs) and implantable cardioverter-defibrillators (ICDs) inserted continues to increase. Beginning early in the 21st century, there has also been an expansion in the indications for cardiac implantable electronic devices (CIED, a term which includes PPMs and ICDs), resulting in device therapy becoming more complex and more prolonged over the patient's lifetime. As such, therapy with a CIED frequently involves multiple leads and multiple pulse generators per patient over each patient's lifetime with the device, exposing the patient to greater operative risk as well as ongoing risk related to the CIED.

There are a variety of potential complications associated with CIED use, both at and around the time of implantation as well as long-term over the life of the patient and his/her device [1-3]. Efforts to avoid some of these complications have led to the development of new technologies (ie, leadless pacemakers, subcutaneous ICDs). The long-term complications associated with a CIED will be reviewed here. Procedural and peri-procedural complications associated with CIED implantation, as well as basic principles associated with PPMs, ICDs, and alternative technologies, are discussed separately. (See "Cardiac implantable electronic devices: Peri-procedural complications" and "Permanent cardiac pacing: Overview of devices and indications" and "General principles of the implantable cardioverter-defibrillator" and "Permanent cardiac pacing: Overview of devices and indications", section on 'Leadless systems' and "Subcutaneous implantable cardioverter defibrillators".)


Major complications requiring reoperation or hospitalization were analyzed in a cohort of 114,484 patients aged 65 years or greater (mean age 74.8 years, 72 percent male) who were enrolled in the National Cardiovascular Data Registry (NCDR) ICD registry and received a first ICD between 2006 and 2010 [4]. Over a median follow-up of 2.7 years, ICD-related complications requiring hospitalization or reoperation occurred at a rate of 6.1 per 100 patient-years.

Pulse generator malfunctions are a rare but significant long-term complication, particularly for patients who are pacemaker-dependent. In a 2006 meta-analysis which included patients from three registries, including 475,618 PPMs and 20,633 ICDs implanted between 1974 and 2004, rates of device malfunction (pulse generator only, no data on lead malfunctions was reported) were 1.3 per 1000 person-years for PPMs and 26.5 per 1000 person-years for ICDs, although the complication rates fell significantly over time [5].  

Lead malfunctions, another rare but significant potential long-term complication, are more common in ICD leads, with significant variability in the rates of malfunction in certain leads. Reported lead failure rates have varied from 1 to 9 percent at two years, 2 to 15 percent at five years and 5 to 40 percent at 8 to 10 years [6-8]. Comparison of rates are confounded by varying definitions of lead failure, differences among lead models, varying patient and clinician characteristics, and limitations of methods for detection of lead malfunction [7].


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Literature review current through: Dec 2016. | This topic last updated: Wed Nov 23 00:00:00 GMT+00:00 2016.
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