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(Circulation. 1995;92:2935-2939.)
© 1995 American Heart Association, Inc.

Articles

Steroid Elution Improves the Stimulation Threshold in an Active-Fixation Atrial Permanent Pacing Lead

A Randomized, Controlled Study

George H. Crossley, MD; Jeffrey A. Brinker, MD; Dwight Reynolds, MD; William Spencer, MD; W. Ben Johnson, MD; Howard Hurd, MD; Lisa Tonder; Matt Zmijewski; for the Model 4068 Investigators¹

From the Cardiology Section, Department of Medicine, Bowman Gray School of Medicine, Wake Forest University, Winston-Salem, NC (G.H.C.); Johns Hopkins University, Baltimore, Md (J.A.B.); The University of Oklahoma, Oklahoma City (D.R.); Baylor College of Medicine, Houston, Tex (W.S.); Mercy Hospital, Des Moines, Iowa (W.B.J.); Washington University, St Louis, Mo (H.H.); and Medtronic Inc, Minneapolis, Minn (L.T., M.Z.).

Background Prior work suggests that the addition of a steroid-eluting reservoir to a passive-fixation permanent pacemaker lead improves the stimulation threshold; however, no large randomized study has addressed this issue. Over the last several years, there has been an increase in enthusiasm for the use of active-fixation permanent pacemaker leads for various reasons in spite of the generally accepted notion that active-fixation leads have higher stimulation thresholds.

Methods and Results This multicenter, randomized, controlled study examined the difference in performance between a standard active-fixation atrial lead (Medtronic model 4058) and a steroid-eluting lead (Medtronic model 4068). Stimulation thresholds were obtained in a four-point strength-duration fashion. Evaluations of sensing and impedance were performed as well. These evaluations were performed at implantation, at weeks 1 through 4, and at weeks 6, 12, 24, and 52. Stimulation thresholds were significantly better in the steroid lead than in the nonsteroid lead at each measurement point from 1 week to 12 months. The mean 1.6-V stimulation threshold at 12 months was 0.19±0.2 ms in the steroid lead and 0.41±0.30 ms in the control lead. No acute peaking was observed with the steroid lead, whereas significant peaking was observed with the control lead. There was no difference in long-term sensing or impedance.

Conclusions Inclusion of a steroid-eluting reservoir in an active-fixation permanent pacing lead improved stimulation thresholds in both the subacute and chronic periods and therefore should extend pulse-generator longevity.

Key Words: pacemakers • electrical stimulation • trials

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