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Biomedical subjects

R McVenes

Publications and source records attributed to R McVenes.

4 recordsLinked to original sources

"In-line" bipolar, steroid-eluting, high impedance, epimyocardial pacing lead.

Recent advances in electrode surface designs have eliminated traditional threshold differences between endo- and epicardial pacing leads. Since the epicardial approach offers the potential of direct left ventricular pacing and the transvenous approach may not be feasible or warranted in all instances, more advanced leads are being designed to optimize epicardial pacing capabilities. This study was conducted to evaluate a bipolar epimyocardial lead. Six immature canines (age 3 months) were instrumented. The lead (Medtronic model 10389) is a single-pass, "in-line" bipolar electrode with low current drain and high impedance, with an intramyocardial steroid-eluting cathode and nonsteroid epicardial anode. Twelve ventricular leads were implanted (two per animal) and the animals followed for 6 months with weekly analysis of pacing and sensing capabilities. Results at explant were compared with implant values and showed no significant differences between sensed R waves or in R wave slew rates in unipolar or bipolar modes. Explant lead impedances remained high in both modes: bipolar, 1658 +/- 331; and unipolar, 1327 +/- 308 omega (P < 0.05). Chronic voltage (V) threshold at 0.5 ms showed no significant change from implant values during the study: unipolar, 0.3 +/- 0.06 versus 1.0 +/- 0.8; and bipolar, 0.4 +/- 0.06 versus 1.6 +/- 1.2. Histologic review showed negligible fibrous reaction at the electrode-tissue interface. This study introduces a high impedance, low threshold, "in-line" bipolar pacing lead design capable of stable chronic pacing with implant facilitated by a single suture technique.

Animals

Polyurethane elastomer biostability.

Polyurethanes have unique mechanical and biologic properties that make them ideal for many implantable devices. They are subject to some in vivo degradation mechanisms, however. Polyester polyurethanes are subject to hydrolytic degradation and are no longer used in long-term implanted devices. Polyether polyurethanes, while hydrolytically stable, are subject to oxidative degradation in several forms, including environmental stress cracking and metal ion oxidation. Mineralization is also known to occur. A new polycarbonate polyurethane has superior biostability in early in vivo qualification tests compared to the polyether polyurethanes, including no evidence of hydrolysis, ESC or MIO.

Animals

Improved epimyocardial pacing: initial experience with a new bipolar, steroid-eluting, high impedance lead design.

Epicardial pacing typically is associated with decreased pacing and sensing capabilities compared with the endocardial approach. Since endocardial pacing is neither appropriate nor possible in all instances, this study was conducted to evaluate a new concept in a chronic epimyocardial lead design in six 3-month-old growing dogs. The new bifurcated lead (Medtronic model 10401) is a low current drain, high impedance, steroid-eluting, bipolar design. The implant is facilitated by a suture attached with an atraumatic needle. Twelve ventricular leads were implanted (2 per animal) and followed for 6 months with weekly analysis of pacing and sensing capabilities. Results at explant were compared with implant values. There were no significant differences between implant and explant in sensed R waves, or in the slew rate of the R wave in unipolar or bipolar modes. Lead impedances at explant remained high in both modes: bipolar, 1550 +/- 223; unipolar, 1234 +/- 262 omega (P < 0.05). Chronic voltage (v) threshold at 0.5 msec showed no significant change from implant values during the study: unipolar, 0.4 +/- 0.2 vs 0.7 +/- 0.3; bipolar, 0.5 +/- 0.4 vs 1 +/- 0.5. Histologic evaluations of the electrode tissue interface demonstrated negligible fibrotic capsule formation. This study introduces a new, easily implanted, high impedance, low threshold, bipolar epimyocardial pacing lead design with excellent chronic pacing and sensing characteristics.

Animals