Pacing system malfunction: Evaluation and management
- David L Hayes, MD
David L Hayes, MD
- Professor of Medicine
- Mayo Medical School
Periodic evaluations of an implanted pacemaker are required to maintain optimal programming and to identify any system problem that should be corrected. Common pacing system problems of single and dual chamber pacemakers and the methods of evaluation and therapy will be reviewed here. The malfunctions discussed will be limited to those that are manifest on an ECG rhythm strip.
Complications not related to pacing system malfunction — Other complications not related to pacing are presented separately. These include infections, venous thrombosis and emboli, pacemaker syndrome, tricuspid regurgitation, and specific problems associated with dual-chamber pacemakers. (See "Infections involving cardiac implantable electronic devices" and "Cardiac implantable electronic devices: Long-term complications", section on 'Tricuspid regurgitation' and "Dual chamber pacing system malfunction: Evaluation and management".)
The incidence of pacing system malfunction is difficult to determine due to inconsistent definitions and the lack of any comprehensive reporting mechanism or registry [1,2]. Overall, device hardware is highly reliable . In terms of comparative reliability, there is a higher incidence of complications of leads compared with pulse generators. In terms of lead malfunction, more complex ICD leads have a higher incidence of failure than simpler pacemaker leads. As a result of a series of lead malfunctions, a policy was published by Heart Rhythm Society with lead performance guidelines .
PACING SYSTEM COMPONENTS
The pacing system is comprised of the pulse generator (picture 1), also called the pacemaker, and the lead or leads which connect the pulse generator to the heart.
The phrase "pacing system malfunction" includes problems that might arise from any of the components of the system. Inappropriately programmed pacemaker parameters, although they do not represent abnormal pacing system function, may be suboptimal for the patient. The normal characteristics and unique timing systems and algorithms of a given pacemaker are also an issue, as they may be interpreted as a malfunction by a clinician who is not familiar with the specific pulse generator. Recording system artifacts must always be considered in the differential diagnosis of a pacing system malfunction.
- Maisel WH, Moynahan M, Zuckerman BD, et al. Pacemaker and ICD generator malfunctions: analysis of Food and Drug Administration annual reports. JAMA 2006; 295:1901.
- Maisel WH. Pacemaker and ICD generator reliability: meta-analysis of device registries. JAMA 2006; 295:1929.
- Hauser RG, Hayes DL, Kallinen LM, et al. Clinical experience with pacemaker pulse generators and transvenous leads: an 8-year prospective multicenter study. Heart Rhythm 2007; 4:154.
- Maisel WH, Hauser RG, Hammill SC, et al. Recommendations from the Heart Rhythm Society Task Force on Lead Performance Policies and Guidelines: developed in collaboration with the American College of Cardiology (ACC) and the American Heart Association (AHA). Heart Rhythm 2009; 6:869.
- Maisel WH, Sweeney MO, Stevenson WG, et al. Recalls and safety alerts involving pacemakers and implantable cardioverter-defibrillator generators. JAMA 2001; 286:793.
- Thomas D, Becker R, Katus HA, et al. Radiation therapy-induced electrical reset of an implantable cardioverter defibrillator device located outside the irradiation field. J Electrocardiol 2004; 37:73.
- Kapa S, Fong L, Blackwell CR, et al. Effects of scatter radiation on ICD and CRT function. Pacing Clin Electrophysiol 2008; 31:727.
- Nemec J. Runaway implantable defibrillator--a rare complication of radiation therapy. Pacing Clin Electrophysiol 2007; 30:716.
- Solan AN, Solan MJ, Bednarz G, Goodkin MB. Treatment of patients with cardiac pacemakers and implantable cardioverter-defibrillators during radiotherapy. Int J Radiat Oncol Biol Phys 2004; 59:897.
- Gomez DR, Poenisch F, Pinnix CC, et al. Malfunctions of implantable cardiac devices in patients receiving proton beam therapy: incidence and predictors. Int J Radiat Oncol Biol Phys 2013; 87:570.
- Marbach JR, Sontag MR, Van Dyk J, Wolbarst AB. Management of radiation oncology patients with implanted cardiac pacemakers: report of AAPM Task Group No. 34. American Association of Physicists in Medicine. Med Phys 1994; 21:85.
- Hurkmans CW, Knegjens JL, Oei BS, et al. Management of radiation oncology patients with a pacemaker or ICD: a new comprehensive practical guideline in The Netherlands. Dutch Society of Radiotherapy and Oncology (NVRO). Radiat Oncol 2012; 7:198.
- Makkar A, Prisciandaro J, Agarwal S, et al. Effect of radiation therapy on permanent pacemaker and implantable cardioverter-defibrillator function. Heart Rhythm 2012; 9:1964.
- Zaremba T, Jakobsen AR, Søgaard M, et al. Radiotherapy in patients with pacemakers and implantable cardioverter defibrillators: a literature review. Europace 2016; 18:479.
- Manegold JC, Israel CW, Ehrlich JR, et al. External cardioversion of atrial fibrillation in patients with implanted pacemaker or cardioverter-defibrillator systems: a randomized comparison of monophasic and biphasic shock energy application. Eur Heart J 2007; 28:1731.
- http://www.fda.gov/medwatch/safety/2008/safety08.htm#ElectronicMedical (Accessed on June 12, 2012).
- Platonov MA, Gillis AM, Kavanagh KM. Pacemakers, implantable cardioverter/defibrillators, and extracorporeal shockwave lithotripsy: evidence-based guidelines for the modern era. J Endourol 2008; 22:243.
- Chung MK, Streem SB, Ching E, et al. Effects of extracorporeal shock wave lithotripsy on tiered therapy implantable cardioverter defibrillators. Pacing Clin Electrophysiol 1999; 22:738.
- Complications not related to pacing system malfunction
- PACING SYSTEM COMPONENTS
- PACING STIMULI PRESENT WITH LOSS OF CAPTURE
- Causes of loss of capture
- - Lead dislodgement or malposition
- - Inflammation and fibrosis at the electrode/myocardial interface
- - Increase in capture threshold
- - Sub-threshold pacemaker output programming
- - Lead failure
- - Battery depletion
- - Recording system artifact
- PACING STIMULUS PRESENT WITH FAILURE TO SENSE
- Causes of undersensing
- - Inadequate signal
- - Pacemaker programmed to a value insufficient to sense intrinsic activity
- - Change in native signal
- - Ectopic beats
- - Lead maturation
- - Lead failure
- - Pulse generator failure
- - Environmental electrical fields
- - Magnet application
- - Noise detection
- Management of undersensing
- ELECTROMAGNETIC INTERFERENCE
- Therapeutic radiation
- Therapeutic electrical current
- - External cardioversion/defibrillation
- - Electrocautery
- Magnetic resonance imaging
- Computed tomography
- Extracorporeal shock wave lithotripsy
- PACING STIMULI ABSENT
- - Management
- Open circuit
- Short circuit due to loss of insulation integrity
- - Lead impedance measurements
- - Management
- Recording system artifact
- RECORDING SYSTEM ARTIFACTS
- LEAD EXTRACTION