Quantitative, low cycle, crack initiation fatigue testing of fine wires and CENELEC standard pacing coil.

Uniaxial fatigue testing was performed on different diameters of fine wires made from MP35N. The fatigue limits of the wires differed from each other based on the diameter of the wire. Multiaxial (shear) fatigue testing was also performed on a benchmark coil used to evaluate the fatigue life of all modern pacemaker leads (the CENELEC standard coil). A computer algorithm was used to quantify the maximum shear stress and strain on the coil. The bend radius, coil diameter, wire diameter, and pitch of the coil all affect the shear stress and strain and therefore the fatigue properties of conductor coils. Based on the analysis presented, it was determined that the portion of the CENELEC standard dealing with fatigue, when used in its present format, is not a valid fatigue test for pacemaker leads.

Bipolar pacemaker leads: new materials, new technology.

This commentary is in response to a review published earlier in this journal. It is intended to provide additional information and supplement the original paper. A short review of the failure mechanisms of polyurethane pacing lead materials is provided. Two specific degradation mechanisms, environmental stress cracking and metal ion oxidation, are discussed. Environmental stress cracking has been extensively studied and is a well understood failure mechanism. Methods for reducing the problem have been developed and tested in vivo. As a result, stress cracking failures can be virtually eliminated. Metal ion oxidation failures now dominate pacing lead recalls. Two new materials, polycarbonate urethanes and ethylenetetrafluoroethylene, have been introduced as insulators for pacing leads. These materials do not fail by stress cracking and preliminary test results are very positive.

Comparison of defibrillation efficacy using biphasic waveforms delivered from various capacitances/pulse widths.

The efficacy of the biphasic waveform shock for the defibrillation of the ventricular myocardium has been reported by researchers and physicians. Although many authors have suggested that biphasic waveforms delivered from lower capacitances and shorter pulse widths could result in the reduction of the energy required for successful defibrillation, no report has described the smallest capacitance and pulse width yielding the lowest DFT. In this study, we compared efficacies of the biphasic waveform shocks and DFT safety margins among five different capacitances (175 mu f, 125 mu f. 100 mu f. 75 mu f, and 50 mu f) combined with 1-3 pulse widths. These experiments performed in six dogs used an endocardial lead/subcutaneous patch defibrillation electrode system. The average DFTs at E50 for 175 mu f (6.5/3.5 ms), 125 mu f (6.5/3.5 ms), 100 mu f (6.0/3.0 ms), 75 mu f (4.0/2.0) ms, and 50 mu f (3.0/2.0 ms) were 8.5, 10.0, 11.0, 14.0, and 16.5), respectively. These results indicate that a biphasic waveform delivered from a larger capacitance with a proper pulse width could achieve a higher defibrillation efficacy. All DFTs at E50 for all waveforms were compared to their deliverable energies and maximum stored energies. This comparison indicated a narrow DFT safety margin with capacitances below 100 mu f. Therefore, it is concluded that higher energy and higher leading edge voltage are required for a biphasic waveform delivered from a smaller capacitance with a shorter pulse width. Since the current capacitor technology provides a maximum voltage of 750 V using two capacitors in series, with the electrode impedance system used in this study, smaller capacitors appear to have a decreased probability of defibrillation success at a given energy.

Digital beat-to-beat cardiotachometer.

A beat-to-beat cardiotachometer counting from 27 to 199 beats per minute has been constructed using digital integrated circuits. Power consumption is reduced, and accuracy enhanced, by incorporating a programmed read-only memory. This circuit technique can be employed for other devices, such as digital thermometers, in order to circumvent a nonlinear relationship between voltage and the physiological variable.