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CARDIOVASCULAR
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Clinical Evidence

Clinical Evidence

Customized Therapy Delivery for Improved Outcomes

Abbott 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 margin1-3
  • Failure from traditional methods adds risk, time and cost to the hospital by requiring additional hardware2,4
  • 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
  NICM ICM NICM ICM
14J — 20 (59%) — 24 (34%)
21J 7 (20%) 3 (9%) 17 (24%) 8 (11%)
25J 1 (3%) 3 (9%) 7 (10%) 3 (4%)
31J 0 0 6 (8%) 4 (6%)
35J 0 0 2 (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 Sci., 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.

References

  1. Leong-Sit, P., Gula, L. J., Diamantouros, P., Krahn, A. D., Skanes, A. C., Yee, R., & Klein, G. J. (2006). Effect of defibrillation testing on management during implantable cardioverterdefibrillator implantation. American Heart Journal, 152(6), 1104-1108.
  2. Russo, A. M., Sauer, W., Gerstenfeld, E. P., Hsia, H. H., Lin, D., Cooper, J. M., ... Marchlinkski, F. E. (2005). Defibrillation threshold testing: is it really necessary at the time of implantable cardioverter-defibrillator insertion? Heart Rhythm, 2, 456-461.
  3. Shukla, H. H., Flaker, G. C., Jayam, V., & Roberts, D. (2003). High defibrillation thresholds in transvenous biphasic implantable defibrillators: clinical predictors and prognostic implications. PACE, 26(1 Pt 1), 44-48.
  4. Cooper, J., Latacha, M., Soto, G., Garmany, R. G., Gleva, M. J., Chen, J., ... Smith, T. W. (2008). The azygos defibrillator lead for elevated defibrillation thresholds: implant technique, lead stability, and patient series. PACE, 31, 1405-1410.
  5. Gabriels, J., Budzikowski, A., & Kassotis, J. (2013). Defibrillation Waveform Duration Adjustment Increases the Proportion of Acceptable Defibrillation Thresholds in Patients Implanted with Single-Coil Defibrillation Leads. Cardiology, 124(2), 71-75.
  6. Natarajan, S., Henthorn, R., Burroughs, J., Esberg, D., Zweibel, S., Ross, T., ... Oza, A. (2007). “Tuned” Defibrillation Waveforms Outperform 50/50% Tilt Defibrillation Waveforms: A Randomized Multi-Center Study. Pacing Clin Electrophysiol, 1, S139-42.
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