© 2002 by European Society of Cardiology
PACING
High incidence of Pellethane 90A lead malfunction
State University of New York Health Sciences Center at Stony Brook, Department of Medicine — Division of Cardiology U.S.A.
Manuscript submitted 15 May 2001. Accepted after revision 14 October 2001.
Correspondence: Roman T. Pachulski, MD, FACC, Director of Arrhythmia Services and Electrophysiology Laboratory, Health Sciences Center T-17-020, SUNY Stony Brook, Stony Brook, New York 11794-8171, U.S.A. E-mail: roman01866{at}aol.com
Key Words: Pellethane 90A, pacemaker leads, insulation malfunction
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Aims |
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The long-term performance of Pellethane 80A (P80A) endocardial pacing leads has previously been called into question. We report our experience with an endocardial pacemaker lead with silicone outer and Pellethane 2363-90A (P90) inner insulator.
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Methods |
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Between November 1993 and March 1998, 129 P90A and 189 non-P90A ventricular leads were implanted. Lead malfunction was defined as
25% deviation in lead impedance or a two-fold reduction in sensing threshold during follow-up. Sensing and capture thresholds and lead impedance were assessed intraoperatively, immediately postoperatively, at 24 h and 6–12 weeks following implant and semiannually thereafter. Adequacy of lead positioning and lead-header interface were documented radiographically in each case. |
Results |
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During 204 patient years of follow-up, 10/129 (8%) Oscor RX P90A leads malfunctioned. Average time to malfunction was 14±11 months. During 166 patient years of follow-up, none of the 189 non-P90A ventricular leads met criteria for malfunction (P< 0·05). There was no difference in patient age, sex, and arrhythmia indication between groups. Sensing problems were overcome with pacemaker reprogramming.
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Conclusion |
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TopAimsMethodsResultsConclusionReferences |
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We conclude that Oscor RX passive fixation ventricular leads with external silicone and inner P90A insulation exhibit an 8% insulation malfunction rate within 14±11 months of implant. This is significantly higher than non-P90A leads implanted with identical technique and follow-up regimen. More frequent follow up may be warranted in patients with P90A containing leads.
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References |
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