Cardiac implantable electronic devices: Peri-procedural complications
- Leonard I Ganz, MD, FHRS, FACC
Leonard I Ganz, MD, FHRS, FACC
- Section Editor — Cardiac Arrhythmias
- Director of Cardiac Electrophysiology
- Heritage Valley Health System
As more people are living longer with more significant cardiac disease, the number of permanent pacemakers (PPMs) and implantable cardioverter-defibrillators (ICDs) in clinical practice 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]. Procedural and peri-procedural complications associated with CIED implantation will be reviewed here. The long-term complications associated with a CIED, as well as basic principles associated with both PPMs and ICDs, are discussed separately. (See "Cardiac implantable electronic devices: Long-term complications" and "Permanent cardiac pacing: Overview of devices and indications" and "General principles of the implantable cardioverter-defibrillator" and "Secondary prevention of sudden cardiac death in heart failure and cardiomyopathy", section on 'Our approach' and "Primary prevention of sudden cardiac death in heart failure and cardiomyopathy".)
Overall, reported implant complication rates range from 3 to 6 percent, although the exact incidence of peri-procedural CIED complications is difficult to determine due to inconsistent definitions and the lack of mandatory reporting [4-7]. However, following the establishment of the National Cardiovascular Data Registry (NCDR) ICD Registry by the American College of Cardiology, information is now available for all ICDs implanted in the United States . Unfortunately, there is no contemporary nationwide registry of pacemaker implants, although some pacemaker complications can be estimated from ICD data, such as pneumothorax rates in single and dual lead systems [9-11].
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 NCDR ICD registry and received a first ICD between 2006 and 2010 . Within the initial 90 days following implantation, approximately 5.4 percent of patients experience an ICD-related complication requiring hospitalization and/or reoperation.
The overall rate of complications appears to have declined over the period from 2006 to 2010, although rates remain somewhat higher in elderly populations and female patients .
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- PROCEDURAL COMPLICATIONS
- Initial implantation
- - Transvenous lead systems
- Cardiac perforation
- - Epicardial lead systems
- - Shoulder-related problems
- Operator characteristics
- Explantation and reimplantation
- PERI-PROCEDURAL MONITORING
- INFORMATION FOR PATIENTS
- SUMMARY AND RECOMMENDATIONS