In national and international bodies, there is active discussion of appropriate safety regulations of levels of magnetic field strength in MRI. Present limits are usually expressed in terms of the switching rate dB/dt, but the validity of this is open to debate. Application of the fundamental law of electrostimulation is well-established, both on theoretical and experimental grounds. Application of this law, in combination with Maxwell's law, yields a very simple equation that we call the fundamental law of magnetostimulation. This law has the hyperbolic form of a strength-duration curve and allows an estimation of the lowest possible value of the magnetic flux density capable of stimulating nerves and muscles. Calculations prove that the threshold for heart excitation is much higher than those for nerve and muscle stimulations. Experimental results from us and other authors confirm the correctness of the derived laws for magnetostimulation. In light of these findings, proposed safety limits should be reconsidered.

Asynchronous pacing due to magnetostatic and gradient fields may be problematic in patients with spontaneous rhythm. To avoid them, PM triggered MRI scan restricted to refractory period is proposed. Neither inhibition of PM nor heating of the electrode poses real risks. So far, we have examined eight patients 12 times in MRI triggered mode without problems.

The topic of interference of pacemakers by mobile phones has evoked a surprisingly strong interest, not only in pacemaker patients, but also in the public opinion. The latter is the more surprising, as in the past, the problem of interference has scarcely found the attention that it deserves in the interest of the patient. It was the intention of our investigation to test as many pacemaker models as possible to determine whether incompatibility with mobile phones of different modes may exist, using an in vitro measuring setup. We had access to 231 different models of 20 manufacturers. During the measurements, a pulse generator together with a suitable lead was situated in a 0.9 g/L saline solution, and the antenna of a mobile phone was positioned as close as possible. If the pulse generator was disturbed, the antenna was elevated until interference ceased. The gap in which interference occurred was defined as "maximum interference distance." All three nets existing in Germany, the C-net (450 MHz, analogue), the D-net (900 MHz, digital pulsed), and the E-net (1,800 MHz, digital pulsed) were tested in succession. Out of 231 pulse generator models, 103 pieces corresponding to 44.6% were influenced either by C- or D-net, if both results were totaled. However, this view is misleading as no patient will use C- and D-net phones simultaneously. Separated into C- or D-net interference, the result is 30.7% for C or 34.2% for D, respectively, of all models tested. The susceptible models represent 18.6% or 27% of today's living patients, respectively. All models were resistant to the E-net. With respect to D-net phones, all pacemakers of six manufacturers proved to be unaffected. Eleven other manufacturers possessed affected and unaffected models as well. A C-net phone only prolonged up to five pacemaker periods within 10 seconds during dialing without substantial impairment to the patient. Bipolar pacemakers are as susceptible as unipolar ones. The following advice for patients and physicians can be derived from our investigations: though 27% of all patients may have problems with D-net phones (not C- or E-net), the application should generally not be questioned. On the contrary, patients with susceptible devices should be advised that a distance of 20 cm is sufficient to guarantee integrity of the pacemaker with respect to hand held phones. Portables, on the other hand, should have a distance of about 0.5 m. Pacemaker patients really suffering from mobile phones are very rare unless the phone is just positioned in the pocket over the pulse generator. The contralateral pocket or the belt position guarantees, in 99% of all patients, undisturbed operation of the pacemaker. A risk analysis reveals that the portion of patients really suffering from mobile phones is about 1 out of 100,000. Nevertheless, it would be desirable in the future if implanting physicians would use only pacemakers with immunity against mobile phones as guaranteed by the manufacturers.

This large-scale real-life patient cohort of primary stationary pacemaker implantation showed that gender has an impact onto pacemaker implantation, with less favourable outcomes for women.

Describing mathematically, the intensity duration curves of electrostimulation by hyperbolas, Lapicque introduced two terms which characterized the functional relationship: "Rheobase" was the lowest intensity with indefinite pulse duration which just stimulated muscles or nerves. "Chronaxie" was that pulse duration at which the threshold intensity was twice that of the rheobase. Up to now, both terms have never played an important role in cardiac pacing. However, it can be shown that the chronaxie, especially, is an important parameter--influenced by several factors such as electrode size, material, and stimulation mode--which may help match the generator to its electrode. Practical consequences may be derived from the concept of chronaxie: 1) A pulse duration longer than the chronaxie is not desirable because current consumption is increased without decreasing the threshold significantly. 2) Pacing with constant current needs twice that pulse duration of constant voltage stimulation. 3) Smaller electrodes are more favorable because the pulse duration they need may be reduced without losing safety. 4) Estimation of the safety margin with decreasing output of the generator or with programmable pulse duration is possible if the chronaxie of a specific electrode is known.

How do active implantable medical devices react in the presence of strong magnetic fields in the frequency range between extremely low frequency (ELF) to radiofrequency (RF) as they are emitted by electronic security systems (ESS)? There are three different sorts of ESSs: electronic article surveillance (EAS) devices, metal detector (MDS) devices, and radiofrequency identification (RFID) systems. Common to all is the production of magnetic fields. There is an abundance of literature concerning interference by ESS gates with respect to if there is an influence possible and if such an influence can bear a risk for the AIMD wearers. However, there has been no attempt to study the physical mechanism nor to develop a model of how and under which conditions magnetic fields can influence pacemakers and defibrillators and how they could be disarmed by technological means. It is too often assumed that interference of AIMD with ESS is inevitable. Exogenous signals of similar intensity and rhythm to heart signals can be misinterpreted and, thus, confuse the implant. Important for the interference coupling mechanism is the differentiation between a "unipolar" and a "bipolar" system. With respect to magnetic fields, the left side implanted pacemaker is the most unfavorable case as the lead forms approximately a semicircular area of maximum 225 cm2 into which a voltage can be induced. This assumption yields an interference coupling model that can be expressed by simple mathematics. The worst-case conditions for induced interference voltages are a coupling area of 225 cm2 that is representative for a large human, a homogeneous magnetic field perpendicular to the area formed by the lead, and a unipolar ventricular pacemaker system that is implanted on the left side of the thorax and has the highest interference sensitivity. In bipolar systems the fields must be 17 times larger when compared to a unipolar system to have the same effect. The magnetic field for interfering with ICDs must be 1.7 stronger than that of the most sensitive unipolar pacemaker. The lowest interference thresholds measured over the last 10 years in the low frequency range (16 2/3 Hz-24 kHz) together with thresholds > 24 kHz that were supplied by the CETECOM study are listed. Both sets of data together with the coupling model, allow for judging which fields of ESSs could influence AIMDs. From measurements at gate antennas, it is possible to derive a "maximum allowed field" curve over the whole frequency range, below which no interference will occur. Comparison of data from literature with these maximum allowed fields confirm the correctness of the calculations. Thus, it is possible to predict interference situations in gates if the magnetic field is known. If all future pacemakers were to have the immunity against interference of the better 50% of today's pacemakers, the magnetic field ceiling values could be at least four times higher. The same is true if the ventricular sensitivity is routinely set at 7 mV. Pacemaker manufacturers should consider filter im...

The statement that the optimal pulse for defibrillation has not yet been discovered implies that an ideal pulse exists, but that it is different in shape, duration, and energy as compared to pulses of today. The optimum pulse is that which can defibrillate with lowest energy. Reduction of energy can be reached twofold: by looking for a pulse duration with lowest energy threshold, and by finding the optimal truncation with lowest refibrillating effect. Assuming that there is also a rheobase in defibrillation below which no defibrillating but probably a refibrillating effect exists, the exponential pulse should be truncated if it intersects with the rheobase. Combining the fundamental law of electrostimulation with this boundary condition allows for the mathematical solution of the above problem of optimal energy. Defibrillation can be optimized with respect to pulse duration or tilt and to energy efficiency. The most important parameter in determining other optimized parameters such as output capacitor is the chronaxie. The calculations reveal that the "concept of constant energy" does not accurately describe defibrillation, that today's implantable cardioverter defibrillator devices possess refibrillating tilts, that pulse durations should be programmed to values between 4 and 10 msec, and that smaller output capacitors around 30 microF would minimize the energy requirements. Whether optimized monophasic pulses are inferior or equal to biphasic pulses needs further experimental studies.

Around the turn of the last century, there was an intensive discussion among physiologists as to whether there is a law describing the phenomena of electrostimulation and which formula may best approximate it mathematically. J.L. Hoorweg found in 1892 that the voltage at which a capacitor must be charged to elicit an excitation, was a function of the capacitance in an inverse correlation. G. Weiss reported in 1901 that according to his investigations a linear relationship existed between the duration of a pulse and the corresponding quantity of electricity applied and called it "formule fondamentale." We are now able to give the "fundamental formula" a physical interpretation that yields, as result, the electric field produced by the electrode acting on the excitable membrane. The electric field in the extracellular space is transformed by the cell geometry ratio: cell length to membrane thickness yielding a high transmembrane field capable of reducing the inherent electric field to its threshold level. The consequences drawn from this hypothesis are remarkable and (should) have an influence on all applications of electrostimulation including the discussions on defibrillation. The application of the stimulation theory to defibrillation yields as results: (1) The basic engineering principle of defibrillation is to produce an electric field within the ventricles of 400 V/m or more. An orthogonal pulse application may reduce the energy requirements, as more fibers are longitudinally reached by the electric field; (2) The shape of the defibrillation pulse and its polarity plays no role. Consequently it follows that biphasic pulses must be less efficient than monophasic pulses, if they are close to the chronaxie; and (3) The most serious disadvantage in today's defibrillation practice is its dose characterization in "energy"; but this physical quantity cannot be justified in the light of the fundamental law of electrostimulation.