Advertisement

Feasibility of Subcutaneous ECG Leads for Synchronized Timing of a Counterpulsation Device

  • S. Warren
  • G. A. Giridharan
  • R. D. Dowling
  • P. A. Spence
  • L. Tompkins
  • Eric Gratz
  • L. C. Sherwood
  • M. A. Sobieski
  • C. R. Bartoli
  • M. S. Slaughter
  • Robert S. Keynton
  • S. C. Koenig
Article

Abstract

A counterpulsation device (Symphony) that works synchronously with the native heart to provide partial circulatory support was developed to treat patients with advanced heart failure. Symphony is implanted in a ‘pacemaker pocket’ without entry into the chest, and requires timing with ECG for device filling and ejection. Surface leads are limited to short-term use due to signal distortion and lead management issues. Transvenous leads are a clinical standard for pacemakers and internal defibrillators, but increase the complexity of the implant procedure. In this study, the feasibility of using subcutaneous leads for synchronized timing of Symphony was investigated. ECG waveforms were simultaneously measured and recorded using epicardial (control) and subcutaneous (test) leads in a bovine model for 7-days (n = 6) and 14-days (n = 2) during daily activity and treadmill exercise. Landmark features and R-wave triggering detection rates for each lead configuration were calculated and compared. Lead placement, migration, durability, and infection were quantified using fluoroscopy and histopathological examination. There were 2,849 data epochs (30-s each) recorded at rest (133,627 analyzed beats) and 35 data epochs (20 min each) recorded during treadmill exercise (37,154 analyzed beats). The subcutaneous leads provided an accurate and reliable triggering signal during routine daily activity and treadmill exercise (99.1 ± 0.4% positive predictive value, 96.8 ± 1.5% sensitivity). The subcutaneous leads were also easily placed with minimal lead migration (0.5 ± 0.1 cm), damage (no fractures or failures), or infection. These findings demonstrate the feasibility of using subcutaneous leads for synchronized timing of mechanical circulatory support while offering the advantage of less invasive surgery and associated risk factors.

Keywords

Subcutaneous Electrocardiogram ECG leads Heart failure Mechanical circulatory support 

Notes

Acknowledgments

This study was funded by NIH SBIR phase I grant 1R43HL102981-01. Funding was provided to SCR (Louisville, KY) and the University of Louisville by NIH-SBIR phase II (R43HL102981) and Kentucky Science & Technology (KSTC-184-512-08-054) grants.

Disclosures

Landon Tompkins, Robert Dowling, MD and Paul Spence, MD are employees of SCR Inc (Louisville, KY) with commercial interests in the development of the Symphony system. Eric Gratz is an employee of Abiomed Inc (Danvers, MA) with commercial interests in the development of the Symphony system.

References

  1. 1.
    Bardy, G. H., et al. An entirely subcutaneous implantable cardioverter-defibrillator. N. Engl. J. Med. 363(1):36–44, 2010.CrossRefGoogle Scholar
  2. 2.
    Bartoli, C. R., et al. A novel subcutaneous counterpulsation device: acute hemodynamic efficacy during pharmacologically induced hypertension, hypotension, and heart failure. Artif. Organs. 34(7):537–545, 2010.CrossRefGoogle Scholar
  3. 3.
    Bellardine, B., et al. Is surface ECG a useful surrogate for subcutaneous ECG? Pacing Clin. Electrophysiol. 33(2):135–145, 2010.CrossRefGoogle Scholar
  4. 4.
    Drew, G., and S. Koenig. Biomedical patient monitoring, data acquisition, and playback with LabVIEW. In: Virtual Bio-Instrumentation: Biomedical, Clinical, and Healthcare Applications in LabVIEW, edited by J. B. Olansen, and E. Rosow. Upper Saddle River, NJ: Prentice Hall, 2002, pp. 180–186.Google Scholar
  5. 5.
    Fotuhi, P., et al. R wave detection by subcutaneous ECG. possible use for analyzing R R variability. Ann. Noninvas. Electrocardiol. 6(1):18–23, 2001.CrossRefGoogle Scholar
  6. 6.
    Frankel, R. A., et al. A filter to suppress ECG baseline wander and preserve ST-segment accuracy in a real-time environment. J. Electrocardiol. 24(4):315–323, 1991.CrossRefGoogle Scholar
  7. 7.
    Giridharan, G. A., et al. Predicted hemodynamic benefits of counterpulsation therapy using a superficial surgical approach. ASAIO J. 52(1):39–46, 2006.CrossRefGoogle Scholar
  8. 8.
    Gomes, J. A., et al. Optimal bandpass filters for time-domain analysis of the signal-averaged electrocardiogram. Am. J. Cardiol. 60(16):1290–1298, 1987.CrossRefGoogle Scholar
  9. 9.
    Grace, A., et al. Evaluation of four distinct subcutaneous implantable defibrillator (S-ICD®) lead systems in humans. Heart Rhythm 3:S128–S129, 2006.CrossRefGoogle Scholar
  10. 10.
    Hanlon-Pena, P. M., and S. J. Quaal. Intra-aortic balloon pump timing: review of evidence supporting current practice. Am. J. Crit. Care 20(4):323–333, 2011.CrossRefGoogle Scholar
  11. 11.
    Hassler, C. ECG lead placement in quadrupeds. Telemetry Times (Technical Note, 8/3/94). Data Sciences Int, 1994.Google Scholar
  12. 12.
    Ho, C., and S. Kurtzman. Three perspectives of cardiac electrical activity. Biomed. Sci. Instrum. 37:325, 2001.zbMATHGoogle Scholar
  13. 13.
    Iglesias, J. F., et al. The implantable loop recorder: a critical review. Kardiovaskuläre Medizin 12(3):85–93, 2009.Google Scholar
  14. 14.
    Kautzner, J., et al. Technical aspects of implantation of LV lead for cardiac resynchronization therapy in chronic heart failure. Pacing Clin. Electrophysiol. 27(6p1):783–790, 2004.CrossRefGoogle Scholar
  15. 15.
    Koenig, S. C., et al. Integrated data acquisition system for medical device testing and physiology research in compliance with good laboratory practices. Biomed. Instrum. Technol. 38(3):229–240, 2004.Google Scholar
  16. 16.
    Koenig, S. C., et al. Development and early testing of a simple subcutaneous counterpulsation device. ASAIO J. 52(4):362, 2006.Google Scholar
  17. 17.
    Koenig, S. C., et al. Acute hemodynamic efficacy of a 32-ml subcutaneous counterpulsation device in a calf model of diminished cardiac function. ASAIO J. 54(6):578, 2008.Google Scholar
  18. 18.
    Lawton, J. S., et al. Sensing lead-related complications in patients with transvenous implantable cardioverter-defibrillators. Am. J. Cardiol. 78(6):647–651, 1996.CrossRefGoogle Scholar
  19. 19.
    Lobodzinski, S. S., M. M. Laks, S. S. Lobodzinski, and M. M. Laks. Comfortable textile-based electrocardiogram systems for very long-term monitoring. Cardiol. J. 15(5):477, 2008.Google Scholar
  20. 20.
    Meyns, B., et al. Proof of concept: hemodynamic response to long-term partial ventricular support with the synergy pocket micro-pump. J. Am. Coll. Cardiol. 54(1):79–86, 2009.CrossRefGoogle Scholar
  21. 21.
    Nanas, J. N., and S. D. Moulopoulos. Counterpulsation: historical background, technical improvements, hemodynamic and metabolic effects. Cardiology 84(3):156–167, 1994.CrossRefGoogle Scholar
  22. 22.
    Pantalos, G. M., S. C. Koenig, K. J. Gillars, G. S. Haugh, R. D. Dowling, and L. A. Gray. Intraaortic balloon pump timing discrepancies in adult patients. Artif. Organs. 35(9):857–866, 2011.CrossRefGoogle Scholar
  23. 23.
    Papaioannou, T. G., and C. Stefanadis. Basic principles of the intraaortic balloon pump and mechanisms affecting its performance. ASAIO J. 51(3):296–300, 2005.CrossRefGoogle Scholar
  24. 24.
    Pino, E., et al. Real-time ECG Algorithms for Ambulatory Patient Monitoring. 2005. American Medical Informatics Association.Google Scholar
  25. 25.
    Schreuder, J. J., et al. Beat-to-beat effects of intraaortic balloon pump timing on left ventricular performance in patients with low ejection fraction. Ann. Thorac. Surg. 79(3):872–880, 2005.CrossRefGoogle Scholar
  26. 26.
    Schwartzman, D., et al. Postoperative lead-related complications in patients with nonthoracotomy defibrillation lead systems. J. Am. Coll. Cardiol. 26(3):776–786, 1995.CrossRefGoogle Scholar
  27. 27.
    Thakor, N. V., J. G. Webster, and W. J. Tompkins. Estimation of QRS complex power spectra for design of a QRS filter. IEEE Trans. Biomed. Eng. (11):702–706, 1984.Google Scholar

Copyright information

© Biomedical Engineering Society 2011

Authors and Affiliations

  • S. Warren
    • 1
  • G. A. Giridharan
    • 1
  • R. D. Dowling
    • 3
  • P. A. Spence
    • 3
  • L. Tompkins
    • 3
  • Eric Gratz
    • 4
  • L. C. Sherwood
    • 5
  • M. A. Sobieski
    • 2
  • C. R. Bartoli
    • 6
  • M. S. Slaughter
    • 2
  • Robert S. Keynton
    • 1
  • S. C. Koenig
    • 1
    • 2
  1. 1.Department of BioengineeringCardiovascular Innovation Institute, University of LouisvilleLouisvilleUSA
  2. 2.Department of Surgery, Division of Cardiothoracic SurgeryUniversity of LouisvilleLouisvilleUSA
  3. 3.SCR IncLouisvilleUSA
  4. 4.Abiomed IncDanversUSA
  5. 5.Research Resources Facilities (RRF)University of LouisvilleLouisvilleUSA
  6. 6.University of Louisville School of MedicineLouisvilleUSA

Personalised recommendations