HIGH FAILURE RATE OF THE 5 FRENCH SORIN HEPTA 4B PACEMAKER LEAD
H.G.R. Dorman, J.M. Van Opstal, J. Stevenhagen, M.F. Scholten
Medisch Spectrum Twente Thoraxcentrum Twente, Department of Cardiology Enschede, The Netherlands
Introduction: The 5 Fr Sorin Hepta 4B lead is a bipolar transvenous pacemaker lead. We observed an unexpected high failure rate of this pacemaker lead. The aim of this study was to determine the performance of the Hepta 4B lead.
Methods: : In the Medisch Spectrum Twente, a total of 98 Sorin Hepta 4B right ventricular pacemaker leads were implanted. Analysis of the pacemaker database and patients’ charts was performed to assess the rate of lead-related complications of all implanted Hepta 4B leads, requiring lead replacement.
Results: Median time of follow up was 5.5 (4.2 - 6.4) years. Of the 98 implanted Hepta 4B leads, 21% (21/98) were replaced. A total of 18% (18/98) of the leads showed electrical malfunction, leading to symptoms in 5% (5/98) of the patients. Electrical malfunction included impedance change, threshold rise and sensing problems. The Kaplan-Meier curve of lead failure free survival during follow-up is shown in figure 1.
Conclusions: We report an extreme and unexpected failure rate of the Sorin Hepta lead. The most common complication was electrical dysfunction.
The reason for this phenomenon has to be analyzed, but the co-radial multifilar design, allowing a smaller diameter of the lead, may explain this finding
Figure 1. Kaplan-Meier curve of lead failure free survival during follow-up.
Figure 2. Schematic lead design of a contemporary co-axial pacemaker lead (A) and the small-diameter co-radial multifilar Sorin Hepta 4B lead (B). In the 5 Fr Hepta 4B lead the tip and ring electrodes are individually insulated. (With courtesy of Sorin Group)
