Far-field R-Wave reduction with a novel lead design: Experimental and human results

Introduction: The purpose of this study was to examine a bipolar screw-in lead (NL), specially designed to reduce unwanted far-field R-wave (FFRW) signal detection in an acute human setting. The results were compared with animal experiments. Methods: The newly designed lead with a center-to-center distance between the anode and cathode electrodes of 3.23 mm, corresponding to an inter-electrode spacing of 1.1 mm was implanted in nine canines with a follow-up of 6 months. Sensing of P waves, FFRW signals, pacing threshold, and impedance was measured at regular intervals. As a result of the positive outcome with the animal study, an acute human experiment was performed. In patients scheduled for conventional dual chamber pacemaker implantation, the NL was compared to a Tendril(R) Model 1388T bipolar screw-in lead (St. Jude Medical, CRMD, Sylmar, GA). Results: Utilizing a tip-to-ring distance of 1.1 mm, the optimum P wave to FFRW ratio was found in animal experiments. In the acute human tests in 15 patients, the mean P-wave voltage of the 1388T lead of 3.30 +/- 1.54 mV was slightly larger than that of the NL, at 2.55 +/- 1.11 mV but did not differ significantly (P = 0.13). The FFRW voltage of the 1388T lead was 0.62 +/- 0.37 mV and was significantly greater from that of the NL, at 0.10 +/- 0.08 mV(P < 0.0001). Pacing thresholds and pacing impedances were comparable. Conclusion: Animal testing results were reproducible in the acute human test setting. The lead reduced the paced FFRW signal amplitudes significantly, allowing for high atria] sensitivity settings but without sensing the FFRW. A robust P-wave signal could be retained.