Performance of Atrial Fibrillation Detection in a New Single-Chamber ICD.

BACKGROUND: Patients with implantable cardioverter defibrillators (ICDs) often have a history of atrial fibrillation (AF) or will develop AF after device implant. Optimal management of ICD patients includes early diagnosis of AF and monitoring of AF burden. We evaluated the performance of an algorithm for monitoring AF in single-chamber ICDs. METHODS: The RR interval variability-based detection algorithm determines RR variability by creating a Lorenz plot of the change in RR intervals for the most recent interval pair versus the previous interval pair. A new plot is created every 2 minutes and the AF evidence score of the plot is computed. Patient RR interval data from several Holter databases were pooled to test the performance of the AF detection algorithm. RESULTS: In total, 187 recordings from 186 patients were used to assess the performance of the AF detection algorithm integrated into a single-chamber ICD by comparing the ICD detection results to the Holter annotated truth. Thirty-five of 186 patients had a total of 94 AF episodes in their Holter recordings lasting a total of 250.5 hours (mean episode duration 7.2 hours). The generalized estimating equations-adjusted estimate of episode sensitivity was 94.8% with 95% lower confidence limit of 87.2%. Gross duration sensitivity was 95.0% for AF episodes of at least 6 minutes duration with gross duration specificity of 99.6%. CONCLUSION: This RR interval-based AF detection algorithm performs well with high sensitivity and specificity. Integration of this algorithm into single-chamber ICDs will help monitor and detect AF, thus facilitating optimal therapy to prevent AF-related sequelae.

Clinical outcomes with synchronized left ventricular pacing: analysis of the adaptive CRT trial.

BACKGROUND: Acute studies have suggested that left ventricular pacing (LVP) may have benefits over biventricular pacing (BVP). The adaptive cardiac resynchronization therapy (aCRT) algorithm provides LVP synchronized to produce fusion with the intrinsic activation when the intrinsic atrioventricular (AV) interval is normal. The randomized double-blind adaptive cardiac resynchronization therapy trial demonstrated noninferiority of the aCRT algorithm compared to echocardiography-optimized BVP (control). OBJECTIVE: To examine whether synchronized LVP (sLVP) resulted in better clinical outcomes. METHODS: First, stratification by percent sLVP (%sLVP) and multivariate Cox proportional hazards model was used to assess the relationship between %sLVP and clinical outcomes. Second, outcomes were compared between patients in the aCRT arm (n = 318) and control patients (n = 160) stratified by intrinsic AV interval at randomization. RESULTS: In the aCRT arm, %sLVP ≥50% (n = 142) was independently associated with a decreased risk of death or heart failure hospitalization (hazard ratio 0.49; 95% confidence interval 0.28-0.85; P = .012) compared with %sLVP <50% (n = 172). A greater proportion of patients with %sLVP ≥50% improved in Packer's clinical composite score at 6-month (82% vs. 68%; P = .002) and 12-month (80% vs. 62%; P = .0006) follow-ups compared to controls. In the subgroup with normal AV (n = 241), there was a lower risk of death or heart failure hospitalization (hazard ratio 0.52; 95% confidence interval 0.27-0.98; P = .044) with the aCRT algorithm. A greater proportion of patients in the aCRT arm improved in the clinical composite score at 6-month (81% vs. 69%; P = .041) and 12-month (77% vs. 66%; P = .076) follow-ups compared to controls. CONCLUSIONS: Higher %sLVP was independently associated with superior clinical outcomes. In patients with normal AV conduction, the aCRT algorithm provided mostly sLVP and demonstrated better clinical outcomes compared to echocardiography-optimized BVP.

Automated vulnerability testing identifies patients with inadequate defibrillation safety margin.

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.

Intracardiac QT integral on far-field ICD electrogram predicts sustained ventricular tachyarrhythmias in ICD patients.

BACKGROUND: Prediction of sustained ventricular tachycardia (VT)/ventricular fibrillation (VF) could help to guide preventive interventions in at-risk patients. The QRST integral (∫QT) reflects intrinsic repolarization properties. OBJECTIVE: The objective of this study was to determine whether intracardiac ∫QT predicts VT/VF in the next few months in patients with implantable cardioverter defibrillators (ICDs). METHODS: Far-field (FF) and near-field (NF) right ventricular intracardiac electrograms (EGMs) were recorded via telemetry in 46 patients with structural heart disease and ICDs implanted for secondary prevention of sudden cardiac death. Epochs of 4.9 ± 0.4 minutes during sinus rhythm (mean heart rate 70.9 ± 15.2 beats/min) and ventricular pacing at 105 beats/min were analyzed. Mean ∫QT was calculated on FF and NF EGMs as the algebraic sum of areas under the QRST curve and adjusted by mean heart rate. Patients were followed up for at least 3 months. True VT/VF events treated by the ICD served as the end point. RESULTS: During a mean follow-up of 4.6 months, 22 patients (48%) were treated for VT/VF. Unadjusted and adjusted by heart rate, FF EGM ∫QT in sinus rhythm was a significant predictor of VT/VF (unadjusted ∫QT hazard ratio 1.007; 95% confidence interval 1.002 to 1.0013; P = .007; adjusted ∫QT hazard ratio 1.68; 95% confidence interval 1.19 to 2.36; P = .002). The highest quartile of intracardiac ∫QT predicted VT/VF (log-rank test P = .042) and identified patients at risk with a specificity of 86% and positive predictive value of 73%. CONCLUSION: Increased intracardiac FF EGM ∫QT predicts VT/VF in patients with structural heart disease and secondary prevention ICDs.

Intracardiac electrogram T-wave alternans/variability increases before spontaneous ventricular tachyarrhythmias in implantable cardioverter-defibrillator patients: a prospective, multi-center study.

BACKGROUND: T-wave alternans (TWA) increases before ventricular tachycardia (VT) or fibrillation (VF), suggesting that it may warn of VT/VF in implantable cardioverter-defibrillator patients. Recently, we described a method for measuring alternans and nonalternans variability (TWA/V) from electrograms (EGMs) stored in implantable cardioverter-defibrillators before VT/VF. The goal of this prospective, multicenter study was to determine whether EGM TWA/V was greater before VT/VF than at baseline. METHODS AND RESULTS: We enrolled 63 implantable cardioverter-defibrillator patients. TWA/V was computed from stored EGMs before spontaneous VT/VF and from sequential windows of 8 pairs of beats using 4 different control recordings: baseline rhythm, rapid pacing at 105 bpm, segments of ambulatory Holter EGMs matched to the time of VT/VF episodes, and EGMs before spontaneous supraventricular tachycardia. During follow-up, 28 patients had 166 episodes of VT/VF. TWA/V was greater before VT/VF (62.9 ± 3.1 µV; n = 28) than during baseline rhythm (12.8 ± 1.8 µV; P < 0.0001; n = 62), during rapid pacing (14.5 ± 2.0 µV; P < 0.0001; n = 52), before supraventricular tachycardia (27.5 ± 6.1 µV; P < 0.0001; n = 9), or during time-matched ambulatory controls (12.3 ± 3.5 µV; P < 0.0001; n = 16). By logistic regression, the odds of VT/VF increased by a factor of 2.2 for each 10-µV increment in TWA/V (P < 0.0001). CONCLUSIONS: In implantable cardioverter-defibrillator patients, EGM TWA/V is greater before spontaneous VT/VF than in control recordings. Future implantable cardioverter-defibrillators that measure EGM TWA/V continuously may warn patients and initiate pacing therapies to prevent VT/VF.

Downloadable software algorithm reduces inappropriate shocks caused by implantable cardioverter-defibrillator lead fractures: a prospective study.

BACKGROUND: Downloadable software upgrades are common in consumer electronics but not in implantable medical devices. Fractures of implantable cardioverter-defibrillator (ICD) leads present commonly as inappropriate shocks. A lead-integrity alert (LIA) designed to reduce inappropriate shocks is the first software download approved to enhance nominally functioning, previously implanted ICDs. METHODS AND RESULTS: We performed a prospective study to determine whether an LIA could reduce inappropriate shocks. Patients were included if they had ICD lead fractures confirmed by analysis of explanted leads. The LIA group included the first 213 patients who met the inclusion criteria after the LIA was approved who had the LIA downloaded. The LIA is triggered either by high impedance or rapid oversensing. It responds by delaying detection of ventricular fibrillation and initiating a patient alert every 4 hours. The control group included the first 213 patients who did not have the LIA downloaded. They were monitored by conventional daily impedance measurements that respond with a daily alert. The LIA group had a 46% relative reduction (95% confidence interval 34% to 55%) in the percentage of patients with ≥1 inappropriate shock (LIA 38% versus control 70%, P<0.001) and a 50% relative reduction (95% confidence interval 33% to 61%) in the percentage with ≥5 shocks (25% versus 50%, P<0.001). The LIA group also had a higher percentage of patients who either did not receive a shock or had ≥3 days of warning before the shock (72% versus 50%, P<0.001). CONCLUSIONS: A software download that upgrades previously implanted ICDs without surgical revision reduces inappropriate shocks caused by lead fractures.

Downloadable algorithm to reduce inappropriate shocks caused by fractures of implantable cardioverter-defibrillator leads.

BACKGROUND: The primary method for monitoring implantable cardioverter-defibrillator lead integrity is periodic measurement of impedance. Sprint Fidelis leads are prone to pace-sense lead fractures, which commonly present as inappropriate shocks caused by oversensing. METHODS AND RESULTS: We developed and tested an algorithm to enhance early identification of lead fractures and to reduce inappropriate shocks. This lead-integrity algorithm, which can be downloaded into presently implanted implantable cardioverter-defibrillators, alerts the patient and/or physician when triggered by either oversensing or excessive increases in impedance. To reduce inappropriate shocks, the lead-integrity algorithm increases the number of intervals to detect (NID) ventricular fibrillation when triggered. The lead-integrity algorithm was tested on data from 15 970 patients with Fidelis leads (including 121 with clinically diagnosed fractures) and 95 other fractured leads confirmed by analysis of returned product. The effect of the NID on inappropriate shocks was tested in 92 patients with 927 shocks caused by lead fracture. Increasing the NID reduced inappropriate shocks (P<0.0001). The lead-integrity algorithm provided at least a 3-day warning of inappropriate shocks in 76% (95% CI, 66 to 84) of patients versus 55% (95% CI, 43 to 64) for optimal impedance monitoring (P=0.007). Its positive predictive value was 72% for lead fractures and 81% for lead fractures or header-connector problems requiring surgical intervention. The false-positive rate was 1 per 372 patient-years of monitoring. CONCLUSIONS: A lead-integrity algorithm developed for download into existing implantable cardioverter-defibrillators increases short-term warning of inappropriate shocks in patients with lead fractures and reduces the likelihood of inappropriate shocks. It is the first downloadable RAMware to enhance the performance of nominally functioning implantable cardioverter-defibrillators and the first implantable cardioverter-defibrillator monitoring feature that triggers real-time changes in ventricular fibrillation detection parameters to reduce inappropriate shocks.

High amplitude T-wave alternans precedes spontaneous ventricular tachycardia or fibrillation in ICD electrograms.

BACKGROUND: T-wave alternans (TWA) increases acutely prior to ventricular tachycardia (VT) or fibrillation (VF) in animal studies, suggesting that it may provide a warning for VT/VF in implantable cardioverter defibrillator (ICD) patients. Clinically, measurement of surface ECG TWA requires preprocessing the input signal to reduce noise and/or analyzing more sinus beats than are recorded in ICDs as pre-onset, stored intracardiac electrograms (EGMs) before VT/VF. Our objective was to measure TWA from the few sinus EGMs stored in ICDs before spontaneous VT/VF in humans. OBJECTIVE: The purpose of this study was to evaluate the technical feasibility of measuring TWA from pre-onset ICD EGMs and to measure EGM TWA before spontaneous VT/VF in humans. METHODS: We developed a method to measure EGM TWA as a simple average (AVE) of peak-to-peak alternans. Using simulation, we determined the effect of ICD signal processing on EGM TWA for durations comparable to those in pre-onset EGMs. We then applied this method to pre-onset ICD EGMs that preceded 101 episodes of sustained VT/VF in 10 patients. In 6 of these patients, EGM recordings in atrial pacing and sinus rhythm provided control data. RESULTS: In simulation, the AVE method discriminated input TWA differences > or = 15 microV. In patients, EGM TWA was 78 +/- 62 microV prior to VT/VF vs. 13 +/- 10 microV in control recordings (p< .0001). Eighty percent of pre-onset measurements exceeded 30 microV, while 95% of control measurements were less than 30 microV. CONCLUSIONS: A simple averaging method can measure TWA preceding VT/VF in stored ICD EGMs. Pilot data indicate that high-amplitude EGM TWA usually precedes spontaneous VT/VF and is infrequent in control recordings. They provide a rationale for developing ICD technology to measure EGM TWA continuously, both to warn patients and to initiate pacing algorithms to prevent VT/VF.

Effect of programmed number of intervals to detect ventricular fibrillation on implantable cardioverter-defibrillator aborted and unnecessary shocks.

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.

Comparison of Laplacian and bipolar ECGs for R-wave detection during noise.

Body surface Laplacian mapping localizes cardiac activity and provides more detailed distributions compared to body surface potential mapping. Systematic comparison of the performance of bipolar and Laplacian ECGs during noise has not been performed. To determine whether Laplacian ECGs (2.5 cm diameter concentric rings) can reduce noise (myopotential and motion artifacts) and improve signal to noise ratio (SNR) compared to bipolar (4 cm spacing) ECGs, Laplacian and bipolar ECGs were recorded from the anterior (precordial V3) and lateral (precordial V6) chest regions in 25 patients undergoing posture changes and in-office exercises. Mean peak-to-peak (Vpp), root mean square noise (Noise(rms)) and SNR were computed across all activities and patients. Sensing performance using an R-wave detector with an auto-adjusting exponentially decaying threshold was assessed. Across all maneuvers, mean Vpp was larger for the bipolar ECG compared to the Laplacian ECG on the anterior (0.65 +/- 0.07 vs. 0.14 +/- 0.07 mV, p<0.05) and lateral (0.65 +/- 0.07 vs. 0.05 +/- 0.07 mV, p<0.05) regions. Laplacian ECGs resulted in least Noise(rms) compared to bipolar ECGs (anterior: 0.02 +/- 0.01 vs. 0.05 +/- 0.01, p<0.05; lateral: 0.01 +/- 0.01 vs. 0.07 +/- 0.01, p<0.05). Bipolar and Laplacian SNRs were comparable on the anterior chest (14.05 +/- 0.95 vs. 13.49 +/- 0.95, p=NS). On the lateral chest, bipolar SNR was larger than Laplacian SNR (13.78 +/- 0.95 vs. 8.67 +/- 0.96, p<0.05). Laplacian SNR on the anterior chest was larger compared to the lateral chest, confirming that Laplacian ECGs are sensitive to mapping location. Sensing performance showed that bipolar ECGs resulted in marginally superior sensing accuracy compared to Laplacian ECGs. In conclusion, Laplacian ECGs offer no advantage in SNR compared with standard bipolar ECGs.

Detection and management of an implantable cardioverter defibrillator lead failure: incidence and clinical implications.

OBJECTIVES: This study evaluated the long-term reliability of an implantable cardioverter defibrillator (ICD) lead to determine the incidence, clinical presentation, and management of lead failure. BACKGROUND: Despite recent advances in ICD technology, the long-term reliability of ICD leads remains a significant problem. METHODS: Concern about long-term reliability of coaxial polyurethane ICD leads caused us to systematically study all patients implanted with Medtronic (Minneapolis, Minnesota) 6936 lead at our institution. We performed follow-up of 74 patients with 76 ICD leads that were implanted from February 28, 1995 to September 8, 1997. Thirty-seven patients underwent routine clinical ICD follow-up testing and ventricular fibrillation induction to determine the status of their ICD lead after a mean follow-up of 68.6 +/- 8.2 months. RESULTS: The lead survival analysis shows a cumulative failure probability of 37% (confidence interval, 24% to 54%) at 68.6 months. Six patients demonstrated a previously undescribed mode of ICD lead failure: prolonged oversensing immediately after shock therapy. The use of short interval counters to monitor nonphysiologic R-R intervals and the measurement of ring-to-coil impedance detected early lead failures in five patients. CONCLUSIONS: This analysis shows: 1) problems with ICD leads may not become apparent until late during follow-up and may become a significant late problem, 2) a "signature" mode of lead failure for the 6936 consisting of oversensing of electrical noise following shocks, 3) early detection of lead failure with a short interval counter algorithm or measurement of ring-to-coil impedance may be clinically useful.