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.

Automated left ventricular capture management.

BACKGROUND: The stimulation thresholds of left ventricular (LV) leads tend to be less reliable than conventional leads. Cardiac resynchronization therapy (CRT) requires continuous capture of both ventricles. OBJECTIVE: The purpose of this study is to evaluate a novel algorithm for the automatic measurement of the stimulation threshold of LV leads in cardiac resynchronization systems. METHODS: We enrolled 134 patients from 18 centers who had existing CRT-D systems. Software capable of automatically executing LV threshold measurements was downloaded into the random access memory (RAM) of the device. The threshold was measured by pacing in the left ventricle and analyzing the interventricular conduction sensed in the right ventricle. Automatic LV threshold measurements were collected and compared with manual LV threshold tests at each follow-up visit and using a Holter monitor system that recorded both the surface electrocardiograph (ECG) and continuous telemetry from the device. RESULTS: The proportion of Left Ventricular Capture Management (LVCM) in-office threshold tests within one programming step of the manual threshold test was 99.7% (306/307) with a two-sided 95% confidence interval of (98.2%, 100.0%). The algorithm measured the threshold successfully in 96% and 97% of patients after 1 and 3 months respectively. Holter monitor analysis in a subset of patients revealed accurate performance of the algorithm. CONCLUSION: This study demonstrated that the LVCM algorithm is safe, accurate, and highly reliable. LVCM worked with different types of leads and different lead locations. LVCM was demonstrated to be clinically equivalent to the manual LV threshold test. LVCM offers automatic measurement, output adaptation, and trends of the LV threshold and should result in improved ability to maintain LV capture without sacrificing device longevity.

Acute evaluation of programmer-guided AV/PV and VV delay optimization comparing an IEGM method and echocardiogram for cardiac resynchronization therapy in heart failure patients and dual-chamber ICD implants.

INTRODUCTION: Intracardiac delay optimization of biventricular and dual-chamber pacing devices currently relies on time-consuming echocardiographic measurements. A novel intracardiac electrogram (IEGM) method for atrioventricular (AV/PV) and interventricular (VV) delay optimization was developed, which can be performed during routine device follow-up. METHODS AND RESULTS: In this prospective, nonrandomized, multi-center trial, patients previously implanted with St. Jude Medical cardiac resynchronization therapy defibrillator (CRT-D) devices or dual-chamber implantable cardioverter defibrillators (ICDs) underwent standard AV/PV and/or VV delay optimization guided by Doppler echocardiogram measurements of the maximum aortic velocity time integral (aortic VTI). Aortic VTI measurements applying the IEGM method recommended delays were then obtained in all patients. Fifty-eight patients (age: 68 +/- 11 years; 81% male; 74% ischemic) and 57 patients (age: 71 +/- 10 years; 74% male; 71% ischemic) were enrolled for AV/PV and VV delay evaluation, respectively. An independent core lab determined the maximum aortic VTIs. Data analysis of the AV, PV, and VV delays demonstrated the concordance correlation coefficient (CCC) between the standard method aortic VTI values and the IEGM method aortic VTI values was 97.5%, 96.1%, and 96.6%, respectively. All analyses demonstrated that the CCC > 90% (P < 0.05). CONCLUSION: The automated programmer-based IEGM method provides a reliable and simpler alternative to standard techniques for the optimization of AV/PV and VV delay settings in patients with CRT-D devices and dual-chamber ICDs.

Reduction of RV pacing by continuous optimization of the AV interval.

BACKGROUND: In patients requiring permanent pacing, preservation of intrinsic ventricular activation is preferred whenever possible. The Search AV+ (SAV+) algorithm in Medtronic EnPulsetrade mark dual-chamber pacemakers can increase atrioventricular (AV) intervals to 320 ms in patients with intact or intermittent AV conduction. This prospective, multicenter study compared the percentage of ventricular pacing with and without AV interval extension. METHODS: Among 197 patients enrolled in the study, the percentage of ventricular-paced beats was evaluated via device diagnostics at the 1-month follow-up. Patient cohorts were defined by clinician assessment of conduction via a 1:1 AV conduction test at the 2-week follow-up. The observed percentage of ventricular pacing with SAV + ON and the predicted percentage of ventricular pacing with SAV + OFF were determined from the SAV + histogram data for the period between the 2-week and 1-month follow-up visits. RESULTS: Of 197 patients, 110 (55.8%) had intact 1:1 AV conduction, of which 109 had 1-month data. SAV + remained ON in 99/109 patients; 10 patients had intrinsic A-V conduction intervals beyond SAV + nominal and therefore SAV + disabled. The mean percentage of ventricular pacing in the 109 patients was SAV+ ON = 23.1% (median 3.7%) versus SAV + OFF = 97.2% (median 99.7%). In 87 patients without 1:1 AV conduction, SAV + was programmed OFF in 6, automatically disabled in 52, and remained ON in 29. In 8 of these patients, 80-100% reduction in ventricular pacing was observed with SAV + ON. CONCLUSION: The Search AV+ algorithm in the EnPulse pacemaker effectively promotes intrinsic ventricular activation and substantially reduces unnecessary ventricular pacing.

Automatic measurement of atrial pacing thresholds in dual-chamber pacemakers: clinical experience with atrial capture management.

BACKGROUND: The Medtronic EnPulse pacemaker incorporates the new atrial capture management (ACM) algorithm to automatically measure atrial capture thresholds and subsequently manage atrial pacing outputs. OBJECTIVES: The purpose of this study was to evaluate the clinical performance of ACM. METHODS: Two hundred patients with an indication for a dual-chamber pacemaker underwent implantation. ACM thresholds and manually measured atrial pacing thresholds were assessed at follow-up visits. Clinical equivalence was defined as the ACM-measured threshold being within -0.25 V to +0.5 V of the manually measured threshold. The clinician analyzed all ACM measurements performed in-office for evidence of proarrhythmia. RESULTS: All 200 implanted patients had a 1-month visit, and validated manual and in-office ACM threshold data were available for 123 patients. The ACM threshold was 0.595 +/- 0.252 V, and the manual threshold was 0.584 +/- 0.233 V. The mean difference was 0.010 V with a 95% confidence interval of (-0.001, 0.021). The mean difference over all visits was 0.011 V. For all patients, the individual threshold differences were within the range of clinical equivalence at all visits. No atrial arrhythmias were observed during 892 ACM tests in 193 patients. CONCLUSION: This study demonstrated that the ACM algorithm is safe, accurate, and reliable over time. ACM was demonstrated to be clinically equivalent to the manual atrial threshold test in all patients at 1 month and over the entire follow-up period of up to 6 months. ACM ensures atrial capture, may save time during follow-up, and can be used to manage atrial pacing outputs.

Bachmann's bundle versus right atrial appendage capture.

The tissue in the high intraatrial septum in the region of Bachmann's Bundle (BB) exhibits electrophysiological properties that differ from the right atrial appendage (RAA). As BB pacing emerges as an alternative to RAA pacing, the feasibility of using automatic capture recognition technology in this location should be examined. At implant, active-fixation leads were consecutively placed in the RAA, then the BB in 18 patients (55.5% men, mean age 77.1 +/- 9.1). There was no significant difference between BB and RAA in the average capture threshold (1.12 vs 1.77 V, P = 0.09), sensing threshold (3.85 vs 3.69 mV, P = 0.84), impedance (508 vs 529 Ohms, P = 0.64), evoked response (1.78 vs 1.67 mV, P = 0.83), and polarization (0.41 vs 0.46 mV, P = 0.84) between. The difference in tissue characteristics was not associated with a different evoked response measured by the ventricular capture recognition algorithm. Based on the analogous evoked response and polarization values, capture recognition technology designed for the atrium will most likely be applicable at both pacing sites.