Electrical Performance and Automatic Capture Characteristics of a 3.5‐mm2 Passive Fixation Lead during 1‐Year Follow‐Up

Abstract

Bipolar low polarization electrodes are recommended for a regular AutoCapture (St. Jude Medical, Inc., Sylmar, CA, USA) function in order to effectively detect the evoked response (ER) signal. The objective of this national multicenter registry was to evaluate the electrical performance and the AutoCapture characteristics of the bipolar ventricular pacing lead IsoFlex S, model 1636T or 1646T (St. Jude Medical), in combination with single- and dual-chamber pacemakers. Ventricular pacing and sensing thresholds, lead impedance, ER amplitude, and polarization signals were measured at discharge and routine follow-up visits after 1, 3, 6, 9, and 12 months. AutoCapture activation was recommended based on the results of the ER sensitivity test. Of the 252 patients initially included, 109 (43%) have completed the follow-up. The mean ventricular pacing threshold was 0.43 +/- 0.19 V at discharge and 0.68 +/- 0.32 V at 12 months postimplant. The values for the ventricular sensing threshold were between 9.51 +/- 4.12 and 9.99 +/- 4.09 mV at discharge and at the 12-month follow-up. The unipolar lead impedance decreased from 533 +/- 94 to 476 +/- 73 ohms during the follow-up. The mean ER amplitude was 16.47 +/- 6.70 mV at discharge and 17.42 +/- 7.43 mV after 12 months, and the corresponding mean polarization signals were 0.59 +/- 1.00 and 0.74 +/- 1.24 mV, respectively. AutoCapture activation was recommended in at least 95% of the patients investigated over the 12-month follow-up. The bipolar ventricular pacing lead IsoFlex S 1636/1646T shows a good electrical performance and is mostly compatible with the AutoCapture algorithm.