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Worldwide evaluation of a defibrillation lead with a small geometric electrode surface for high-impedance pacing.

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.

journal_name

Am Heart J

journal_title

American heart journal

authors

Vollmann D,Ahern T,Gerritse B,Canby RC,Zenker D,Binner L,Kimber SK,Unterberg C,Worldwide Medtronic Model 6944 Investigators.

doi

10.1016/S0002-8703(03)00411-3

subject

Has Abstract

pub_date

2003-12-01 00:00:00

pages

1066-70

issue

6

eissn

0002-8703

issn

1097-6744

pii

S0002870303004113

journal_volume

146

pub_type

临床试验,杂志文章,多中心研究,随机对照试验

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