We evaluated the handling performance at implant, and the long-term atrial and ventricular electrical performance of a new generation using a very small surface area (1.2 mm2) steroid-eluting electrode (Medtronic CapSure Z). We compared the performance of CapSure Z to that of traditional passive fixation leads, with and without steroid elution. The study was conducted during 2 years of follow-up. We studied 188 patients (105 males and 83 females; mean age 71 +/- 7 years). All of the patients were implanted with a dual chamber pacemaker and the same type of lead in both chambers. Forty-one patients received CapSure Z leads, 25 patients received Target Tip leads (8-mm2 surface area; no steroid elution), 63 patients received CapSure leads (8-mm2 surface area; steroid elution), and 59 patients received CapSure SP leads (5.8-mm2 surface area; steroid elution). The four groups were homogeneous in regards to sex, age, cardiac disease, and reason for implant. At follow-up, the CapSure Z lead showed sensing values comparable to the other leads, with lower pacing thresholds and higher pacing impedance in both chambers. We evaluated the mean current drained from the pacemaker by the different types of leads when using safe, low energy output settings. We found that by using CapSure Z leads, the mean current was significantly lower than that of the other types of leads (0.42 microA for CapSure Z ventricular lead vs 0.85 for CapSure SP, 1.42 for CapSure, and 1.54 for Target Tip). Thus, the use of the CapSure Z lead, combined with low energy output programming, will increase pacemaker longevity compared to the use of traditional leads and standard output programming.

One hundred and seventy-three patients, mean age 74 years permanently paced with 123 atrial (53 unipolar, 70 bipolar) and 143 ventricular (73 unipolar, 70 bipolar) pacing leads were included in this study. The pacing leads were recent generation low surface area steroid eluting leads from one manufacturer: leads with silicone and polyurethane insulation were studied, and they were combined with generations of one pacemaker family from the same manufacturer permitting identical measurements to be made over a follow-up of 2 years. Pacing threshold was measured using pulse duration at a fixed voltage of 1.5 V: peak to peak P and R wave amplitude and pacing impedance at 2.5 V and 0.5 ms were all measured using the manufacturer's standard programmer. Although many significant differences, in the parameters measures, existed between atrium and ventricle and unipolar and bipolar configurations, none was felt to be of clinical significance. These data permit the physician to choose the lead type with regard to sensing performance and long-term lead integrity.

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We assessed the time course of electrograms sensed both in the atrium and ventricle by two different steroid-eluting electrodes: Medtronic Capsure SP (with an area of 5.5 mm2) and Z (with an area of 1.2 mm2). We considered 68 unipolar electrodes: 31 atrial (19 Capsure SP 4523 and 12 Capsure Z 4533) and 37 ventricular (24 Capsure SP 4023 and 13 Capsure Z 4033) implanted in 47 consecutive patients (30 men and 17 women, with an age of 72 +/- 9.4 years). The pacemaker model was Medtronic Elite 7077-7086 (DDD-DDDR) in 25 patients and Medtronic Legend 8419-8424 (VVIR-AAIR) in 22 patients. The endocavitary signal (all patients had spontaneous rhythm) was telemetrically obtained by a Medtronic 9790 device and acquired on a personal computer at implantation and 7, 30, and 180 days thereafter. The signal was studied both in the time domain and in the frequency domain by spectral analysis. The following parameters were calculated: amplitude (A): peak-to-peak value of the complex; slew rate (SR) peak negative first derivative; F0: frequency at which the power spectrum reaches its maximum value; and bandwidth (Bw): expressed as the distance between the -3 dB points and statistically analyzed by a two-way analysis of variance with factors "time" (four measurements) and "electrode" (Capsure SP and Z) and repeated measurements on the former. Ventricular sensing: no time or electrode effect (P > 0.1 in all comparisons) was found for F0, Bw, or SR, while a time effect (P < 0.04) not dependent on the type of electrode was found for the amplitude of the signal. In particular, a significant increase was found between the measurement at 6 months and that at implantation (P < 0.004). Atrial sensing: A, F0, and bandwidth were not affected by time or electrode (P > 0.09), while SR behaved differently over time (P < 0.05) in the two electrodes (the Capsure Z showed an increase at sixth month [P < 0.04] compared to implantation). In conclusion, the Medtronic Capsure SP and Z electrodes proved to be valid and substantially equivalent as far as concerns the measurement of the intracardiac potential despite the difference between their surface areas. Further studies should be devised to assess whether transitory decreases of atrial Bw in the first month of follow-up observed in a few patients for both electrodes could be responsible for clinical episodes of sensing deficit.

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