Bipolar Leads for Use With Permanently Implantable Cardiac Pacing Systems: A Review of Limitations of Traditional and Coaxial Configurations and the Development and Testing of New Conductor, Insulation, and Electrode Designs

References

• Haffajee C., Casavant D., De sai P., Moon R., Voukydis P., Pacetti P. Combined third-generation implantable cardioverter defibrillator with permanent unipolar pacemakers. PACE. 1996; 19: 136–142
   Google Scholar
• Zeidler D. E. Stress fractures in pacing leads. Medtronic News. 1977; 7: 8–11
   Google Scholar
• Mond H. G. Unipolar versus bipolar pacing—poles apart. PACE. 1991; 14: 1411–1424
   Google Scholar
• Donachy J. H., Tyers GFO, Hughes H. C., Brownlee R. R., Long life flexible electrode lead 1979; Canadian patent application number 350,490, US patent application numbers 06/032,771 and 06/266,211.
   Google Scholar
• Stokes K., Cobian K. Polyetherpolyl rethanes for implantable pacemaker leads. Biomaterials 1982; 3: 225–231
   PubMed Web of Science ®Google Scholar
• Pande G. S. Thermoplastic polyurethanes as insulating materials for long-life cardiac pacing leads. PACE. 1983; 6: 858–867
   Google Scholar
• Phillips R., Frey M., Martin R. Long-term performance of polyurethane pacing leads: mechanisms of design-related failures. PACE. 1986; 9: 1166–1172
   Google Scholar
• Tyers GFO. FDA recalls: how do pacemaker manufacturers compare?. Ann Thorac Surg. 1989; 48: 390–396
   PubMedGoogle Scholar
• Godin J. F., Petitot J. C., Pioger G. STIMAREC report. PACE. 1996; 19: 387–390
   Google Scholar
• Moller M., Arnsbo P. Appraisal of pacing lead performance from the Danish pacemaker register. PACE. 1996; 19: 1327–1336
   Google Scholar
• Phillips R., Smith M., Thoma R. Bomedical applications of poly-urethanes: implications of failure mechanisms. J Biomater Applic. 1988; 3: 207–227
   PubMedGoogle Scholar
• Hayes D., Graham K., Irwin M., et al. A multicenter experience with a bipolar tined polyurethane ventricular lead. PACE. 1992; 15: 1033–1039
   Google Scholar
• Cameron J., Mond H., Ciddor G., Harper K., McKie J. Stiffness of the distal tip of bipolar pacing leads. PACE. 1990; 13: 1915–1920
   Google Scholar
• Rao G. Does stiffness of leads add to thresholds. PACE. 1995; 18: 1819, (Abst)
   Google Scholar
• Glikson M., Von Feldt L. K., Suman V. J., Hayes DL. Clinical surveillance of an active fixation, bipolar, polyurethane insulated pacing lead, part I: the atrial lead. PACE. 1994; 17: 1399–1404
   Google Scholar
• Glikson M., Von Feldt L. K., Suman V. J., Hayes DL. Clinical surveillance of an active fixation, bipolar, polyurethane insulated pacing lead, part II: the ventricular lead. PACE. 1994; 17: 1499–1502
   Google Scholar
• Mond HG., Hua W., Wang CC. Atrial pacing leads: the clinical contribution of steroid elution. PACE. 1995; 18: 1601–1608
   Google Scholar
• Irnich W. Engineering concepts of pacemaker electrodes. Advances in Pacemaker Technology, M. Schaldach, S. Furman. Springer, New York 1975; 241–242
   Google Scholar
• Brinker J. A. Endocardial pacing leads: the good, the bad, and the ugly. PACE. 1995; 18: 953–954
   Google Scholar
• Lloyd M. A., Hayes D. L., Holmes DR, Jr. Arial “J” pacing lead retention wire fracture: radiographic assessment, incidence of fracture, and clinical management. PACE. 1995; 18: 958–964
   Google Scholar
• Ardesia R. J., Saliba B. C., Schoenfeld MI. Evolution of fracture in the atrial “J” lead retention wire. PACE. 1995; 18: 2227–2228
   Google Scholar
• Gozzelino G., Aletto C., De marchi PG, et al. Tricuspid regurgitation after pacemaker implantation. Eur J CPE. 1995; 5: 24–30
   Google Scholar
• Postaci N., Eksi K., Bayata S., Yesil M. Effect of the number of ventricular leads on right ventricular hemodynemics in patients with permanent pacemaker. Angiology 1995; 46: 421424
   Google Scholar
• Fyke F. E. Simultaneous insulation deterioration associated with side-by-side subclavian placement of two polyurethane leads. PACE. 1988; 11: 1571–1574
   Google Scholar
• Tamaki W., Costa R., Crevelary E., Filho M. M., Stolf NAG, Jatene AD. Simultaneous silicone insulation ruptures of transvenous leads. PACE. 1995; 18: 1815, (Abst)
   Google Scholar
• Jacobs D. M., Fink A. S., Miller R. P., et al. Anatomical and morphological evaluation of pacemaker lead compression. PACE. 1993; 16: 434–444
   Google Scholar
• Furman S. Venous cutdown for pacemaker implantation. Ann Thorac Surg. 1986; 41: 438–439
   PubMedGoogle Scholar
• Gurzi G., Important recommendations for patient monitoring: Medtronic models 4004/4004M/4082, Ventricular bipolar pacing leads. Medtronic of Canada Ltd., 8 October 1993.
   Google Scholar
• Boretos J. The chemistry and biocompatibility of specific polyurethanes for medical use. Biocompatibility of Clinical Implant Materials, DR Williams. CRC Press, Boca Raton, FL 1982; VOL II: 127–144
   Google Scholar
• Helguera M. E., Maloney I. D., Pinski S. L., Woscoboinik J. R., Wilkoff B. L., Castle LW. Long-term performance of endocardial pacing leads. PACE. 1994; 17: 56–64
   Google Scholar
• Medtronic Inc. Important patient management information. Product Performance Report. Spring 1996; 1–22
   Google Scholar
• Wilson S., Important patient management information: Medtronic models 4504/4504M/4582 atrial bipolar pacing leads. Medtronic of Canada Ltd., 4 October 1996.
   Google Scholar
• Binner L., Zimmermann F., Nagenrauft S., Kochs M., Hombach V. Unipolar and bipolar impedance measurements to detect insulation failure of bipolar pacing leads. PACE. 1995; 18: 1824, (Abstract & Poster presentation, Xth World Symposium on Cardiac facing, Buenos Aires, Argentina. October 1995).
   Google Scholar
• Medical Devices Bureau of the Health Protection Branch. Report of the advisory committee on the risk-based classification system for medical devices. Ottawa, Canada. September 1994; 1–20
   Google Scholar
• Johnson W. B., Voegtlin L., Greene C., Bailin S. J., Hoyt R. H., Leiserowitz AS. The 4504/M Passive 80A polyurethane atrial lead—another good lead gone bad?. PACE. 1996; 19: 740, (Abst)
   Google Scholar
• Johnson W. B., Greene C., Voegtlin L., et al. Value of unipolarizing safety alert 4004/M80A polyurethane lead… Is it safe?. PACE. 1996; 19: 740, (Abst)
   Google Scholar
• Irwin M. E., Carbol B., Gulamhusein S., Senaratne St.M. Clair WR. Follow-up and intra-op experience with converting in-line bipolar leads showing failure—to a unipolar configuration. PACE. 1995; 18: 1788, (Abst)
   Google Scholar
• Johnson W. B., Voegtlin L., Greene C., Bailin S. J., Hoyt R. H., Leiserowitz AS. The 4504/M Passive 80A polyurethane atrial lead—another good lead gone bad? Poster presentation. 77th Annual Scientific Sessions NASPE., Seattle, WashingtonUSA 17 May, 1996
   Google Scholar
• Gillis A. M., Hillier K., Rothschild J. M., Wyse D. G. Ambulatory ECG monitoring for detection of pacing lead failure. PACE. 1995; 18: 1774, (Abst)
   Google Scholar
• Rosenheck S., Bondy C., Weiss A. T., Gotsman M. S. Comparison between patients with and without reliable ventricular escape rhythm in the presence of long standing complete atrioventricular block. PACE. 1993; 16: 272–276
   Google Scholar
• Johnson W. B., Greene C., Bailin S. J., Edel T. E., Hoyt R. H., Leiserowitz AS. Implications of safety alert ventricular lead… lead replacement?. PACE. 1995; 18: 1802, (Abst)
   Google Scholar
• Pinski S. L., Ching E. A., Sgarbossa E. B., Bash D., Tchou PJ. Pacemaker lead replacement without extraction is not a trivial operation. PACE. 1996; 19: 577, (Abst)
   Google Scholar
• Tyers GFO, Brownlee R. R., Hughes HC, Jr, Donachy J. H., Volz C. Development of an optimal rechargeable cardiac pacemaker. J Surg Res. 1976; 20: 405–411
   PubMedGoogle Scholar
• Longo E., Catrini V. Experience and implantation techniques with a new single-pass lead VDD pacing system. PACE. 1990; 13: 927–936
   Google Scholar
• Lawton J. S., Wood M. A., Gilligan D. M., Stambler B. S., Damiano RJ, Jr, Ellenbogen KA. Implantable transvenous cardioverter defibrillator leads: the dark side. PACE. 1996; 19: 1273–1278
   Google Scholar
• Dillon J. G. Electrochemical degradation of Pellethane 2363-80A and 2363-55D. Polymer Degradation and Stability 1992; 37: 183–188
   Google Scholar
• Szycher M. Biostability of polyurethane elastomers: a critical review. J Biomater Appl. 1988; 3: 297–401
   PubMedGoogle Scholar
• Stokes K., Coury A., Urbanski P. Auto-oxidative degradation of implanted polyether polyurethane devices. J Biomater Appl. 1987; 1: 411–448
   PubMedGoogle Scholar
• Schinko H. ETFE-insulated wires. Siemens Rev. 1975; 42: 407–409
   Google Scholar
• Adler S. C., Foster A. J., Sanders R. S., Wuu E. Thin bipolar leads: a solution to problems with coaxial bipolar designs. PACE. 1992; 15: 1986–1990
   Google Scholar
• Adler S., Spehr P., Allen J., Block W. Chronic animal testing of new cardiac pacing electrodes. PACE. 1990; 13: 1896–1900
   Google Scholar
• Ramsey S., Spehr P., McLean A. Mechanisms of threshold reduction by application of polyethylene glycol to the surface of pacemaker lead electrodes. PACE. 1992; 15: 576, (Abst)
   Google Scholar
• Silverstein B., Furcinitti P. S., Cameron W. A., Brower J. E., White O., Jr. Biological effects summary report-polyethylene glycol. Brookhaven National Laboratory, United States Department of Energy. January, 1984
   Google Scholar
• Brownlee R. R. Toward optimizing the detection of atrial depolarization with floating bipolar electrodes. PACE. 1989; 12: 431–442
   Google Scholar
• Hughes HC, Jr, Tyers GFO, Brownlee RR. Inefficiency of bipolar sensing for demand pacing-fact or fiction. ACEMB. 1977; 30: 135, (Abst)
   Google Scholar
• Tang C., Yeung-Lai-Wah J. A., Qi A., Mills P., Clark J., Tyers GFO. Initial experience with a new co-radial bipolar pacing lead. PACE. 1997, in press.
   Google Scholar
• Tyers GFO, Yeung J., Tang C., et al. Coradial bipolar lead implant and follow-up experience. PACE. 1996; 19: 702, (Abst)
   Google Scholar
• Goldman B. S., Nishimura S., Lau C. Survey of cardiac pacing in Canada(1993). Can J Cardiol. 1996; 12: 573–578
   PubMedGoogle Scholar
• Bernstein A. D., Goldman B. S., Nishimura S., Parsonnet V. Contrasts in cardiac-pacing practice in the United States and Canada: clinical and non-clinical influences. PACE. 1996; 19: 621, (Abst)
   Google Scholar
• Tyers GFO. Current status of sensor-modulated rate-adaptive cardiac pacing. J Am Coll Cardiol. 1990; 15: 412–418
   PubMedGoogle Scholar
• Wilson J. H., Siegmund J. B., Johnson R., Lattner S. E., Fahner SP. Pacing system analyzers: different systems-different results. PACE. 1994; 17
   Google Scholar
• Irwin M. E., Gulamhusein S. S., Senaratne M. P., St. Clair WR. Outcomes of an ambulatory cardiac pacing program: indications, risks, benefits and outcomes. PACE. 1994; 17: 2027–2031
   Google Scholar
• Hayes D. L., VonFeldt L. Clinical surveillance of steroid-eluting passive fixation silicone insulated atrial and ventricular leads. PACE. 1996; 19: 701, (Abst)
   Google Scholar
• Tyers GFO, Yeung J., Gulamhusein S., et al. Experience with new parallel wound bipolar pacing leads. PACE. 1995; 18: 1820, (Abst)
   Google Scholar
• Payne G. E., Dunham D. G., Rao A. C., Crowther A. P., Joseph S. P., Skehan JD. Clinical experience with a new lead combining active fixation with steroid elution. PACE. 1994; 17: 1665–1671
   Google Scholar
• Fogel R., Pirzada F., Casavant D., et al. Initial experience with 1. 5-mm2 high impedance, steroid-eluting pacing electrodes. PACE. 1996; 19: 188
   Google Scholar
• Gumbrielle T. P., Bourke J. P., Sinkovic M., Tynan M., Kittpawong P., Gold RG. Long-term thresholds of nonsteroidal permanent pacing leads: a 5-year study. PACE. 1996; 19: 829–835
   Google Scholar
• Mond H. G., Stokes K., Helland J., Grigg L., Kertes P., Pate B., Hunt D. The porous titanium steroid eluting electrode: a double blind study assessing the stimulation threshold effects of steroid. PACE. 1988; 11: 214–219
   Google Scholar
• Irnich W. Considerations in electrode design for permanent pacing. Cardiac Pacing: Proceedings of the IVth lnternational Symposium on Cardiac Pacing, HJ Thalen, 1973; 268–274
   Google Scholar
• Tyers GFO, Brownlee R. R., Hughes HC, Jr, Shaffer C. W., Williams E. H., Kao RL. Myocardial stimulation impedance: the effects of electrode, physiological and stimulus variables. Ann Thorac Surg. 1979; 27: 63–69
   PubMedGoogle Scholar
• Stokes K. B., Bird T., Gunderson B. The mythology of threshold variations as a function of electrode surface area. PACE. 1991; 14: 1748–1751
   Google Scholar
• Cheesman M., Tyers GFO, Clark J., Mills P. Effect of polarity and voltage regulation on power consumption in cardiac pacemakers. PACE. 1996; 19: 719, (Abst)
   Google Scholar
• Hartley J. W. Programming the pacing voltage: minimizing the energy and maximizing the longevity. CPI Pacing Dynamics 1996; 14–16, Second Quarter
   Google Scholar
• Anonymous., Vigor D. R. CPI Physicians Manual. Cardiac Pacemakers 1994
   Google Scholar
• Toivonen L., Heikkola E. Comparison of pacing threshold development in membrane coated and steroid eluting electrodes. PACE. 1996; 19: 610, (Abst)
   Google Scholar
• Weigand UKH, Potratz J., Luninghake F., Taubert G., Brandes A., Diederich K-W. Electrophysiological characteristics of bipolar membrane carbon leads with and without steroid elution compared with a conventional carbon and a steroid-eluting platinum lead. PACE. 1996; 19: 1155–1161
   Google Scholar
• De Bufallo A. GA, Schlaepfer J., Fromer M., Kappenberger L. Acute and long-term ventricular stimulation thresholds with a new, iridium oxide-coated electrode. PACE. 1993; 16: 1240–1244
   Google Scholar
• Parsonnet V., Bernstein A. D., Neglia D. Nonthroacotomy ICD implantation: lessons to be learned from permanent pacemaker implantation. PACE. 1995; 18: 1597–1600
   Google Scholar
• Parsonnet V. letter to the editor. PACE. 1996; 19: 1401
   Google Scholar
• Tyers GFO, Yeung J., Tang C., et al. Coradial bipolar lead implant and follow-up experience. Poster presentation. 17th Annual Scientific Sessions NASPE. Seattle, WashingtonUSA 17 May, 1996
   Google Scholar