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Do Permanent Pacemakers Need an Insulative Coating? Results of a Prospective Randomized Double‐Blind Study
Author(s) -
DAVIES TED,
DORIAN PAUL,
YAO JAMES,
HART JOHN,
NEWMAN DAVID
Publication year - 1997
Publication title -
pacing and clinical electrophysiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.686
H-Index - 101
eISSN - 1540-8159
pISSN - 0147-8389
DOI - 10.1111/j.1540-8159.1997.tb06076.x
Subject(s) - medicine , stimulation , isometric exercise , single chamber , coating , biomedical engineering , cardiology , population , composite material , materials science , environmental health
During conventional manufacturing of implanted pulse generators (IPGs), an insulative coating is often applied to prevent local muscle stimulation and myopotential sensing in unipolar pacing. This can limit the orientation of the IPG into its pocket, be a potential source of muscle stimulation via coating scratches, and result in an increase in IPG production costs. We hypothesized that advances in the design and construction of current IPCs and leads obviates the need for an insulative coating of the IPG. Using a double‐blind prospective randomized design, 39 patients were implanted with either coated or uncoated otherwise identical IPGs (19 dual, 20 single chamber). All testing was done in unipolar and bipolar mode in both channels. A strength‐duration curve for muscle stimulation was constructed for all patients with muscle stimulation. Myopotential sensing was established during isometric exercise. At 6‐month follow‐up when tested in unipolar mode, 3 of 15 (20%) patients with coated IPCs and 3 of 20 (15%) with uncoated IPCs had muscle stimulation at 5.0 V/ 1.5 ms or lower (P = NS). No patients in either population had muscle stimulation at their normally programmed output. Myopotential sensing occurred in all patients in unipolar mode at a mean of 2.29 ± 1.3 mV and 2.73 ± 1.14 mV for coated versus uncoated, respectively (P = NS). The statistical power of these negative observations was 80%. An insulative coating for pacemakers does not appear to alter sensing performance or cause a significant difference in the occurrence or characteristics of muscle stimulation.