[Effects of 50 to 60 Hz and of 20 to 50 kHz magnetic fields on the operation of implanted cardiac pacemakers]. / Effets des champs magnétiques de 50 et 60 Hz et de 20 à 50 kHz sur le fonctionnement des cardiostimulateurs implantés.

UNLABELLED: The effect of 50 Hz and 60 Hz (frequencies of current distribution) and 20 kHz to 50 kHz (frequencies of induction cooktop) magnetic interference on implanted pacemakers have been assessed with the present generation of device technology. Sixty patients implanted in 1998 and 1999 with dual chamber pacemakers from 9 different manufacturers were monitored with telemetry while passing through, and standing between a system of two coils. They generated a 50 Hz or a 60 Hz magnetic field at 50 microT. Then, patients used a cooktop at different power. The recordings were made with the standard setting of "medically correct" sensing parameters chosen for the patients. Then pacemakers were reprogrammed to the unipolar mode, with the highest atrial (A) and ventricular (V) sensitivity that did not induce muscular inhibition while moving. Between each exposure (50 Hz, 60 Hz or 20 kHz to 50 kHz), the pacemaker programmation was controlled. At the end of the tests, pacemakers will be reprogrammed with the standard setting. The medical observer being blind to the existence or not of the magnetic field. No pacemaker was influenced by the vicinity of the magnetic field at medically correct settings. At unipolar high sensitivity, no inhibition nor reprogramming was observed. Transient reversion to interference mode was observed in 6 cases, 3 transient acceleration due to atrial detection of the interference, and one T wave detection by the ventricular lead. All were observed with the 60 Hz, and only 3 with the 50 Hz magnetic field. One device (Biotronik) shifted out of its special program (hysteresis research) during the tests with the induction cooktop, but it maintained its standard program, and the event could not be repeated despite further testing. CONCLUSION: Actual pacemakers do not present any electromagnetic interference with 50 Hz and 60 Hz or induction cooktop frequency working. They are insensitive with medically correct settings. Unusual high sensitivity leads only to noise reversion mode, or transient ventricular tracking.

[Cardiac Pacemakers, implantable defibrillators and IRM]. / Stimulateurs cardiaques, défibrillateurs implantables et IRM.

The IRM is formally contraindicated to the pacemaker and cardiac defibrillator wearers because of the risk of inhibition or inappropriate stimulations during the examination. However if the examination is essential, suitable programming of the apparatus and a constant monitoring of the heartbeat rate by a qualified doctor in cardiac stimulation must make it possible to avoid any accident.

Low chronic pacing thresholds of steroid-eluting active-fixation ventricular pacemaker leads: a useful alternative to passive-fixation leads.

Active-fixation pacemaker leads enable pacing at various sites, have a low dislodgment rate, and are easier to extract than passive-fixation leads, though are usually not routinely implanted in the ventricle because of their higher pacing threshold. The long-term pacing threshold associated with an active-fixation steroid-eluting lead was prospectively measured in 18 women and 20 men. At a mean follow-up of 14 months (range 3-25 months), pacing threshold increased from 0.71 +/- 0.29 V to 0.96 +/- 0.28 V (P = 0.01) between implant and the first month of follow-up, then remained stable over time, consistently allowing the long-term programming of the ventricular output at 2.5 V, while lead impedance remained stable (from 647 +/- 161 omega at implant to 666 +/- 122 omega at last follow-up). If the long-term performance of this type of lead is confirmed, the routine implantation of ventricular steroid-eluting active-fixation leads should be considered since lead extraction has become a major concern.

[Effect of external electrical interference on pacemakers]. / L'effet des interférences électriques externes sur les stimulateurs cardiaques.

Cardiac pacemaker are sensitive to many kind of electromagnetic interference (EMI). However the low rate of reported effects is due to many protective features. Risks are minimal in everyday life conditions as airport detectors, electronic anti-thief systems, domestic electrical appliances and even mobile phones with the most recent models. Interference detection can be prevented by "medically correct" setting, with the use of bipolar sensing, and ventricular sensitivity above 2 mV. The effect of EMI from the industrial world are difficult to assess and need an individual study. The most important risks occur in the medical world, with the electrocutary, thransthoracic DC shocks, and magnetic resonance imaging.

Spontaneous versus extraction related injuries associated with Accufix J-wire atrial pacemaker lead: tracking changes in patient management.

UNLABELLED: To make recommendations for management of potentially fatal failure of the Accufix series of atrial J-wire permanent pacemaker leads, we closely monitored the number of injuries and fatalities resulting either from spontaneous fracture of the J-wire or from attempts to extract the lead. In a population of 30,357 patients, 2,298 patients are enrolled in a prospective follow-up Multicenter Study, the remainder are patients with known clinical status from voluntary reporting, and 2,992 patients died following implant. In the remaining 27,365 patients, 6 deaths have been attributed to J-wire related injury (J-inj) while 13 were complications (E-inj) associated with 4,076 lead extraction procedures (3,974 intravascular (intra)/102 primary thoracotomy (PT). The date of occurrences were from 1994 to November 1997. CONCLUSIONS: (1) Since lead extractions were not conducted in a controlled study, it is not known whether the deaths associated with lead extraction is in excess of what would have occurred if these leads had not been removed in this specific subset. (2) Awareness of the procedure related complication rate appears to have moderated the rate of lead extraction and may ultimately lead to management that reasonably balances the risks of patient injury.

Kaplan-Meier analysis of freedom from extraction or death in patients with an Accufix J retention wire atrial permanent pacemaker lead: a potential management tool.

UNLABELLED: Morbidity (36 cases) and mortality (6 cases) have been reported in patients with Accufix J retention wire atrial leads. This has resulted in ongoing patient fluoroscopic monitoring as well as lead extractions. The estimated implanted worldwide population is 40,860. Estimating the size of the remaining population at risk is an important tool for assessing patient management guidelines. RESULTS: The Kaplan-Meier method can be used to calculate the cumulative probability of remaining free of extraction and death for patients based on implant duration. The individual Kaplan-Meier curves for lead extraction and patient survival can also be computed. Based on the Multicenter Study (MCS) population of 2,298 patients, the probability that a patient is alive with the lead still implanted at 5 years implant duration is 52.5%. The event-free survival rate at 5 years implant duration is 81.3%. The corresponding probability of remaining free from injury due to the J-wire is 99.9% at 5 years implant duration. Assuming similar rates of death and extraction, these results can be extrapolated to the world wide population. CONCLUSIONS: The management of Accufix patients must consider patient longevity, the probability of J-wire morbidity/mortality, and the probability of extraction complication morbidity/mortality. The probability of remaining at risk as a function of time from implant can be calculated from the events known in the MCS patient population. These event-free survival estimates can be used to identify subsets of the population at greater or lesser risk based on various clinical parameters.

Cumulative hazard analysis of J-wire fracture in the Accufix series of atrial permanent pacemaker leads.

UNLABELLED: To permit a more complete analysis of J-wire fracture in the Accufix series of atrial permanent pacemaker leads, the time to occurrence of all known fractures and injuries has been redefined relative to the duration of risk exposure, that is, according to the interval of time between implant and occurrence of the event. This redefinition permits application of a cumulative hazards model to the data, which previously has not been explored. Predictors of J-wire fracture can be tested using this method. This also permits parametric curve-fitting for determination of linearity or constancy of risk of events over time. RESULTS: Among 2,063 Multicenter Study (MCS) leads analyzed, 381 fractures of the J-wire were identified. Stratified analysis based on cumulative hazard curves identified a more open shape of the J-wire as predictive of fracture, which supports the results previously reported based on logistic regression analysis. Fitting a Weibull curve to the cumulative hazard of J-wire fracture gives a shape parameter equal to 0.85. This value indicates that the instantaneous hazard of J-wire fracture decreased over time from implant. CONCLUSIONS: (1) The cumulative hazard function can be used to examine predictors of J-wire fracture and preliminary findings support the previously identified predictor of J shape; (2) Based on these analyses, the rate of J-wire fracture appears to decrease slightly as time from implant increases.