Worldwide evaluation of a defibrillation lead with a small geometric electrode surface for high-impedance pacing - 28/08/11
Worldwide Medtronic Model 6944 Investigators
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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This study was sponsored by Medtronic, Minneapolis, Minn. |
Vol 146 - N° 6
P. 1066-1070 - décembre 2003 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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