Clinicians caring for cardiac device patients with implanted pacemakers or cardioverter defibrillators (ICDs) are frequently asked questions by their patients concerning electromagnetic interference (EMI) sources and the devices. EMI may be radiated or conducted and may be present in many different forms including (but not limited to) radiofrequency waves, microwaves, ionizing radiation, acoustic radiation, static and pulsed magnetic fields, and electric currents. Manufacturers have done an exemplary job of interference protection with device features such as titanium casing, signal filtering, interference rejection circuits, feedthrough capacitors, noise reversion function, and programmable parameters. Nevertheless, EMI remains a real concern and a potential danger. Many factors influence EMI including those which the patient can regulate (eg, distance from and duration of exposure) and some the patient cannot control (eg, intensity of the EMI field, signal frequency). Potential device responses are many and range from simple temporary oversensing to permanent device damage Several of the more common EMI-generating devices and their likely effects on cardiac devices are considered in the medical, home, and daily living and work environments.
A multicenter study was undertaken to determine the failure rate of a specific bipolar tined polyurethane ventricular pacing lead, the Medtronic 4004/4004M pacing lead. Seven centers in the United States and Canada implanted 586 Medtronic 4004/4004M pacing leads. The study was designed to determine the probability and clinical manifestations of lead failure. Only failures compatible with an insulation problem were included. The Kaplan-Meier estimate of the percentage of 4004/4004M lead failures within 4 years after implantation was 14.1% (95% confidence interval: 8.5%-19.3%). Failures were manifested as sensing abnormalities, failure to capture, early battery depletion, and significant decrease in measured impedance compared with previous impedance measurements. The observed rate of failure is unacceptable, and strong consideration should be given to replacing the 4004/4004M pacing lead in pacemaker dependent patients and closely monitoring nondependent patients.
A multicenter study was undertaken to determine the failure rate of a specific polyurethane bipolar tined pacing lead, the Medtronic 4012 pacing lead. Six centers in the United States and Canada implanted 1,190 Medtronic 4012 pacing leads. The study was designed to determine the probability and clinical manifestations of lead failure. Only failures compatible with an insulation problem were included. The probability of a 4012 lead failure by Kaplan-Meier analysis was 20.9% at 6 years after implantation. Failures were manifested as sensing abnormalities, failure to capture, early battery depletion, and significant decrease in measured impedance compared with the previous impedance measurements. Of the 95 definite lead failures, 16 (16.8%) were associated with symptoms similar to those experienced before pacemaker placement. The observed failure rate is unacceptable, and strong consideration should be given to replacing the 4012 pacing lead in pacemaker-dependent patients and closely monitoring nondependent patients.
A study was undertaken to determine the most effective method of pacemaker follow-up in terms of the total number of complications detected and yield per follow-up in single and dual chamber pacing systems. The analysis involved 9,786 patient records from 635 patients. The records were reviewed with respect to method of follow-up, number of chambers paced, and complications detected. Complications included: oversensing, undersensing, noncapture, pocket and diaphragmatic stimulation, pacemaker mediated tachycardia, crosstalk, pulse generator malfunction, lead malfunction, infection/erosion, premature end of service, exit block, and other miscellaneous problems. Eight thousand two hundred eighty-eight of the 9,786 follow-ups were performed in the office while 1,498 were transtelephonic. Single chamber pacing systems were implanted in 329 patients and 306 were dual chamber systems. A total of 599 complications were detected. Analysis yielded a per patient complication rate of 5.1% (single chamber) and 8.4% (dual chamber) for in-office follow-up. This compared to a transtelephonic follow-up per patient complication rate of only 0.3% (single chamber) and 1.0% (dual chamber). In-office pacemaker follow-up is significantly more effective (P < 0.001) than transtelephonic follow-up in detecting both single and dual chamber pacemaker system complications.
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