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Ellipse™

Implantable Cardioverter Defibrillator (ICD)

Clinical Evidence

Clinical Evidence

Customized Therapy Delivery for Improved Outcomes

DeFT Response™ technology allows physicians to customize rescue therapy to each patient’s unique cardiac physiology and changing condition.

  • One of the greatest risks associated with implantable cardioverter defibrillator (ICD) therapy is failing to attain acceptable defibrillation thresholds (DFTs).
  • The growing trend of ICD implants without DFT testing presents another challenge with the lack of confirmation of an adequate safety margin.
  • It is difficult to predict which patients will have a compromised safety margin.1-3
  • Failure from traditional methods adds risk, time, and cost to the hospital by requiring additional hardware.2,4
  • By combining the ability to measure a patient’s cell depolarization time with consistent HV Lead Impedance, physicians can tailor therapy to an individual patient’s physiology.

Clinical Data to Support DeFT Response Technology

  • DeFT Response technology in Abbott patients resulted in a significantly higher proportion of patients with satisfactory DFTs.5
  • “Tuned” defibrillation waveforms outperform 50/50 tilt defibrillation waveforms.6

 

 

DeFT Response Technology Optimizes Shock Performance With or Without a DFT Test5*

 

DeFT Response technology preserved a 10 J safety margin for 100% of the Abbott patients.

17% of the fixed-tilt group of patients with competitive devices had compromised the 10 J safety margin.

 

Group A: Adjustable

Abbott

Group B: Fixed-tilt

Boston Scientific, Medtronic, Biotronik

 NICMICMNICMICM
14 J—20 (59%)—24 (34%)
21 J7 (20%)3 (9%)17 (24%)8 (11%)
25 J1 (3%)3 (9%)7 (10%)3 (4%)
31 J006 (8%)4 (6%)
35 J002 (3%)0

 

Method: Analysis of DFT levels for 105 patients implanted with a single coil lead between Aug 2007 and Aug 2010.

  • Group A: patients with waveform tuning (Abbott)
  • Group B: patients with fixed-tilt waveform (60% Boston Scientific, 34% Medtronic, 6% Biotronik)

DFT Testing: VF induced by synchronized T-wave shock or direct current pulse. If initial shock failed, second shock delivered at highest energy within 10 J safety margin of device. If unsuccessful, a subcutaneous coil implanted and DFT test repeated. Note: the RV-coil was specifically programmed as an anode in all devices.


*Applies to single coil systems.

Manuals & Technical Resources

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References

  1. Leong-Sit, P., Gula, L. J., Diamantouros, P., Krahn, A. D., Skanes, A. C., Yee, R., & Klein, G. J. Effect of defibrillation testing on management during implantable cardioverterdefibrillator implantation. American Heart Journal. 2006;152(6), 1104-1108.
  2. Russo, A. M., Sauer, W., Gerstenfeld, E. P., Hsia, H. H., Lin, D., Cooper, J. M., ... Marchlinkski, F. E. Defibrillation threshold testing: is it really necessary at the time of implantable cardioverter-defibrillator insertion? Heart Rhythm, 2005;2, 456-461.
  3. Shukla HH, Flaker GC, Jayam V, Roberts D. High defibrillation thresholds in transvenous biphasic implantable defibrillators: clinical predictors and prognostic implications. PACE. 2003;26(1 Pt 1):44-48.
  4. Cooper, J., Latacha, M., Soto, G., Garmany, R. G., Gleva, M. J., Chen, J., ... Smith, T. W. The azygos defibrillator lead for elevated defibrillation thresholds: implant technique, lead stability, and patient series. PACE. 2008;31, 1405-1410.
  5. Gabriels, J., Budzikowski, A., & Kassotis, J. Defibrillation Waveform Duration Adjustment Increases the Proportion of Acceptable Defibrillation Thresholds in Patients Implanted with Single-Coil Defibrillation Leads. Cardiology. 2013;124(2), 71-75.
  6. Natarajan, S., Henthorn, R., Burroughs, J., Esberg, D., Zweibel, S., Ross, T., ... Oza, A. “Tuned” Defibrillation Waveforms Outperform 50/50% Tilt Defibrillation Waveforms: A Randomized Multi-Center Study. Pacing Clin Electrophysiol. 2004;1, S139-42.

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