Activated pyrolytic carbon tip pacing leads: an alternative to steroid-eluting pacing leads?
Pyrolytic carbon technology is known for its excellent mechanical properties and electrical conductivity; it is particularly biocompatible and does not require high production costs. The Sorin S100/4 lead is a ventricular passive fixation lead with a hemispherical electrode surface area of 4 mm2; the stimulating tip is made of a graphite core coated by a thin activated pyrolytic carbon layer. We evaluated the acute and medium-term performance of the unipolar version of this lead in 65 patients. At implantation, pacing threshold (at 0.5 ms) was 0.26 +/- 0.08 V; pacing impedance (at 5 V and 0.5 ms) was 537 +/- 94 omega and R wave amplitude was 15.0 +/- 5.5 mV. No lead related complications (dislodgment, perforation, exit block, etc.) occurred in any patient; one patient presented with a wire fracture after 26 months, due to subclavian crush syndrome. Follow-up procedures were performed at 1 week, and 2-, 10-, 18-, and 30-months postimplant. Since the leads were connected to pacemakers from different manufacturers, either voltage or duration thresholds were measured. In approximately two thirds of the patients, with an output of 2.5 V, a mean duration threshold of 0.16 +/- 0.13 ms at 1 week, 0.12 +/- 0.08 ms at 2 months, 0.11 +/- 0.06 ms at 10 months, 0.09 +/- 0.06 ms at 18 months, and 0.07 +/- 0.03 ms at 30 months, was measured. In the remaining one-third of the patients, a comparable voltage threshold trend was measured. The mean pacing impedance showed a transient drop at 1 week, and then increased to a plateau of about 600 omega reached after 10 months. No sensing defect occurred in any patient. Our data show good acute and intermediate-term results of the S100/4 lead; the early rise in threshold was remarkably blunted. Activated pyrolytic carbon tip leads might therefore be considered as a possible, inexpensive alternative to steroid-eluting leads.
Masini
M
M
Cardiology Department, Campo di Marte Hospital, Lucca, Italy.
Lazzari
M
M
Lorenzoni
R
R
Domicelli
A M
AM
Micheletti
A
A
Dianda
R
R
Masini
G
G
D000368:Aged; D000369:Aged, 80 and over; D001672:Biocompatible Materials / Q000737:chemistry; D002244:Carbon / Q000737:chemistry; D002304:Cardiac Pacing, Artificial; D055598:Chemical Phenomena; D002627:Chemistry, Physical; D003365:Costs and Cost Analysis; D004553:Electric Conductivity; D017097:Electric Impedance; D004567:Electrodes, Implanted; D004867:Equipment Design; D004868:Equipment Failure; D005069:Evaluation Studies as Topic; D005500:Follow-Up Studies; D006108:Graphite / Q000737:chemistry; D006358:Hot Temperature; D006801:Humans; D008875:Middle Aged; D010138:Pacemaker, Artificial; D013256:Steroids / Q000737:chemistry*; D013350:Subclavian Vein / Q000293:injuries; D013499:Surface Properties; D013997:Time Factors; D016276:Ventricular Function
D001672:Biocompatible Materials; D013256:Steroids; C009139:pyrolytic carbon; D002244:Carbon; D006108:Graphite