Why the study?
Do different commercially available transvenous pacing leads have different failure rates during and after implantation?
Do different commercially available transvenous pacing leads have different failure rates during and after implantation?
There are significant differences in intra- and post-operative failure rates among different commercially available transvenous pacing leads, which should inform clinical decision-making.
Observed lead failure differences are hypothesis-generating; does not support changing selection practices without randomized confirmation.
Four commercially available transvenous pacing leads were evaluated in a series of 240 implants on a rotational order basis. Total (intra- and post-operative) failure rates for this series were: Cordis 1 mm, 1/60 (1.7%); Biotronik IE-65-I, 5/60 (8.3%); Medtronic 6961, 4/60 (6.7%); and CPI 4116, 6/60 (10.0%). Post-operative failure rates were: 1 mm, 1/60 (1.7%); IE-65-I, 4/59 (6.8%); 6961, 0/56 (0.0%), and 4116, 3/57 (5.3%). In a previous study conducted at this center with identical protocol, total failure rates were: Medtronic 6907, 7/76 (9.2%); Cordis CL, 7/76 (9.2%); Biotronik IE-65-I, 2/76 (2.6%); and the Vitatron MIP-2000, 9/45 (20.0%). Post-operative failure rates were: 6907, 4/73 (5.5%); CL, 6/75 (8.0%); IE-65-I, 2/76 (2.6%); and MIP-2000, 5/41 (12.2%). If the two IE-65-I series are combined, the total failure rate is 7/136 (5.1%), and the post-operative failure rate is 6/135 (4.4%). Significant differences exist between the highest and lowest failure rates in total and post-operative cases for each series. The final decision concerning use of a particular lead must, of course, be based on clinical criteria.
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Sloman et al. (1981) studied this question.
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