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 | |||
|---|---|---|---|---|
| NICM | ICM | NICM | ICM | |
| 14 J | — | 20 (59%) | — | 24 (34%) |
| 21 J | 7 (20%) | 3 (9%) | 17 (24%) | 8 (11%) |
| 25 J | 1 (3%) | 3 (9%) | 7 (10%) | 3 (4%) |
| 31 J | 0 | 0 | 6 (8%) | 4 (6%) |
| 35 J | 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 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.
References
- 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.
- 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.
- 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.
- 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.
- 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.
- 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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