AI Article Synopsis
- The study evaluated a new defibrillation lead design with a small electrode surface to determine its safety and effectiveness compared to a conventional lead.
- 542 patients received either the new model or a standard model, with no significant differences in lead success rates or defibrillation effectiveness between the two groups.
- Findings showed that while the new lead increased pacing impedance and had slightly smaller R-wave amplitudes, it did not lead to more adverse events or affect patient survival negatively.
Article Abstract
Background: Pacing leads with a small electrode surface for high-impedance stimulation have been shown to prolong pacemaker longevity, but no sufficient data is available on the safety and feasibility of a defibrillation lead with this novel design.
Methods: We evaluated the clinical performance of a tined, steroid-eluting defibrillation lead with a small electrode surface area (model 6944) in a prospective multicenter study. A total of 542 patients with conventional indications for an implantable cardioverter defibrillator were randomized 1:1 to receive either the model 6944 or a tined, steroid-eluting defibrillation lead with a conventional sized electrode surface area (model 6942). Device performance and electrical parameters were evaluated at implant and 1, 3, 6, and 12 months thereafter (mean follow-up 11.3 +/- 5.6 months).
Results: Baseline characteristics, lead implant success rates, and defibrillation thresholds did not differ significantly between the 2 groups. While pacing thresholds did not differ significantly during follow-up, pacing impedance was approximately twice as high in the model 6944 as in the model 6942 lead (P <.0001). Mean R-wave amplitudes were smaller in patients with a 6944 (9.1 +/- 3.1 mV vs 9.8 +/- 3.6 mV for model 6942, P <.05), but remained stable within both groups throughout the observation period. The total number of ventricular lead-related adverse events and patient survival did not differ significantly between the 2 groups.
Conclusions: The use of a defibrillation lead with a small electrode surface for high-efficiency pacing is safe and feasible and increases pacing impedance without significantly compromising clinical performance.
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| http://dx.doi.org/10.1016/S0002-8703(03)00411-3 | DOI Listing |
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