Key result
Medtronic, Guidant, and Ventritex defibrillators showed significant differences in median undersensing (0%, 2.1%, and 5.3%, respectively; P<0.001) during ventricular fibrillation.
Why the study?
Does the sensing and detection performance during ventricular fibrillation differ among implantable defibrillators from different manufacturers?
Does the sensing and detection performance during ventricular fibrillation differ among implantable defibrillators from different manufacturers?
Significant differences exist in sensing and detection performance among different implantable defibrillators during ventricular fibrillation, which may impact clinical practice and device development.
Answers are grounded in this paper and cite their sources.
Manufacturer differences in VF undersensing may affect detection reliability; hypothesis-generating and should not yet change practice.
INTRODUCTION: We prospectively compared the performance of the sensing and detection systems of three leading defibrillator manufacturers: Medtronic, Guidant, and Ventritex. METHODS AND RESULTS: Ventricular fibrillation signal was digitally recorded during defibrillator implantation and subsequently played back sequentially to a Medtronic Micro Jewel II 7223Cx, a Guidant MINI II 1762, and a Ventritex Cadet V-115C. The devices were programmed for single-zone detection, at nominal settings. Rate cutoff was set at 320 msec (185/min for the MINI). We analyzed 253 episodes from 47 patients. Median undersensing was 0%, 2.1%, and 5.3% for the Jewel, MINI, and Cadet, respectively (P < 0.001 for each paired comparison). Detection time was 4.1 +/- 1.6 seconds, 3.4 +/- 1.6 seconds, and 4.3 +/- 2.2 seconds for the Jewel, MINI, and Cadet, respectively (P < 0.001 between MINI-Jewel and MINI-Cadet; P < 0.01 between Jewel-Cadet). Delayed detection (detection time longer than the mean of all observations + 2 SD) occurred in 3 (1.2%), 7 (2.8%), and 18 (7.1%) episodes for the Jewel, MINI, and Cadet, respectively. Performance for all devices was worse when the short-separation integrated bipolar lead was used and when the episode followed a failed high-energy shock. CONCLUSION: Statistically significant differences were seen in sensing and detection performance among the devices and device/lead combinations during ventricular fibrillation. These differences are related to specific features of the respective devices and should be taken into account during clinical practice, as well as in future device development.
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PANOTOPOULOS et al. (2001) studied Ventricular fibrillation (n=47). Implantable defibrillators (Medtronic, Guidant, Ventritex) vs. Comparative performance among the three devices was evaluated on Median undersensing and detection time (p=<0.001). Medtronic, Guidant, and Ventritex defibrillators showed significant differences in median undersensing (0%, 2.1%, and 5.3%, respectively; P<0.001) during ventricular fibrillation.
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