ABSTRACT
BACKGROUND: Implantable cardioverter-defibrillator system efficacy is tested at implant by induction of ventricular fibrillation (VF). Defibrillation safety margin can be assessed without VF induction using upper limit of vulnerability methods, but these methods have required manual determination of T-wave timing. METHODS AND RESULTS: To test the feasibility of an inductionless system of implant testing, a multicenter prospective study of an automated vulnerability safety margin system was conducted, which measured T-wave timing using an intracardiac electrogram during a ventricular pacing train. The system delivered up to 4 T-wave shocks of 18 J. Lack of VF induction by all 4 shocks was considered evidence of defibrillation adequacy. Patients subsequently underwent conventional defibrillation testing to meet a standard implant criterion. The 95% lower CI for defibrillation success at 25 J for noninduced patients was found using Bayesian statistics. Sixty patients were enrolled at 6 centers. Vulnerability testing and defibrillation success results were obtained from 54 patients. Vulnerability testing induced VF in 10 (19%) patients, of whom 2 required system revision. All patients not induced by vulnerability testing were successfully defibrillated twice at ≤25 J. The Bayesian credible interval was 97% to 100% for the population success rate of defibrillation at 25 J for automated vulnerability safety margin noninduced patients. CONCLUSIONS: An automated system identified all patients who failed conventional safety margin testing, while inducing only 19% of patients. Although limited by sample size, this study suggests the feasibility of automated implant testing that substantially reduces the need for VF induction in patients receiving implantable cardioverter-defibrillators.
Subject(s)
Defibrillators, Implantable , Electric Countershock/adverse effects , Equipment Safety/methods , Ventricular Fibrillation/etiology , Ventricular Fibrillation/therapy , Aged , Bayes Theorem , Electrocardiography , Electrophysiologic Techniques, Cardiac , Feasibility Studies , Female , Humans , Male , Materials Testing/methods , Middle Aged , Prospective Studies , Treatment Outcome , Ventricular Fibrillation/physiopathologyABSTRACT
INTRODUCTION: Detection of self-terminating arrhythmias by implantable cardioverter-defibrillators (ICDs) causes unnecessary battery depletion and unnecessary shocks. Our goal was to estimate the effect of the programmed number of intervals to detect (NID) ventricular fibrillation (VF) on ICD temporal episode rate, unnecessary shocks, and delay in detection of VF. METHODS AND RESULTS: We analyzed 773 ICD-detected VF episodes in 875 patients. The number of intervals to detect VF was programmed to 12 of 16 (NID 12) in 305 patients and 18 of 24 (NID 18) in 570 patients. For patients with NID 12, we estimated the increase of mean cumulative episode rate at 6 months since implant and decrease in detection time for VF compared with a hypothetical NID 18. For patients with NID 18, we estimated the decrease of mean cumulative episode rate and unnecessary shocks compared with a hypothetical NID 12. Patients with NID 12 had a 17% increased episode rate resulting in unnecessary capacitor charging for self-terminating arrhythmias. Patients with NID 18 had a 22% decreased episode rate. In patients with NID 12, hypothetical NID 18 would have delayed detection of 273 VF episodes in 1.8 seconds. In patients with NID 18, hypothetical NID 12 would have resulted in inappropriate delivery of 14 aborted shocks in 10% of patients with episodes. CONCLUSION: In patients with self-terminating device-detected VF, increasing the number of intervals to detect VF from 12/16 to 18/24 results in a clinically significant decrease in ICD detections and fewer unnecessary shocks with minimal incremental delay in VF detection.
