Clinical performance of a ventricular automatic capture verification algorithm.

BACKGROUND: This study was conducted to evaluate the clinical performance of the ventricular automatic capture feature as implemented in the Insignia I Ultra pacemaker system (Guidant) utilizing a variety of ventricular leads. Currently, the optimal programming of the pacemaker output considers both pacemaker efficiency (prolonging battery longevity) and patient safety (adequate safety margin). The ability of a pacemaker to automatically adjust the ventricular output above the pacing threshold while maintaining the appropriate safety margin has been explored since the early 1970s and is only available today in conjunction with a specific low polarization lead system. METHODS: One hundred and five patients were enrolled from 17 European centers utilizing 31 different types of ventricular leads were followed through their 3-month follow-up visit. There were no restrictions on the type of ventricular leads used. RESULTS: The average mean difference between the commanded autothreshold test (0.652 + 0.335 V) and the manual threshold test (0.651 + 0.335 V) was 0.001 + 0.49 (P < 0.0001). The average mean difference between the ambulatory autothreshold test (0.696 + 0.322 V) and the commanded autothreshold test (0.682 + 0.315 V) was 0.002 + 0.74 (P < 0.0001). Holter recordings confirmed that there were no loss of capture incidences without a backup pulse being delivered. In addition, the mean number of backup pulses delivered in a 24-hour period was less than 0.1% of the total number of paced beats. CONCLUSIONS: This study provided that the automatic capture feature while using a variety of leads accurately determines the ventricular stimulation threshold and safely delivers a backup pulse when required.

Validation of dual-chamber pacemaker diagnostic data using dual-channel stored electrograms.

BACKGROUND: Pacemaker diagnostic counters are used to guide device programming and patient management. However, these data are susceptible to inappropriate classification of events. The aim of this multicenter study was to evaluate pacemaker diagnostic data using stored intracardiac electrograms (EGMs). METHODS: The study included 351 patients (191 males, aged 71 +/- 10 years) with standard indications for dual-chamber pacemaker implantation. EGM triggers were atrial tachycardia (AT), ventricular tachycardia (VT), sudden bradycardia response (SBR), and pacemaker-mediated tachycardia (PMT). For this study, the devices could store up to 5 EGMs of 8s each (with marker annotation and onset recording). After 3 months, the EGMs were analyzed and classified as "confirmed" if the EGM validated the trigger and as "false positive" if the EGM showed an event different from the trigger. RESULTS: Of the 1,003 EGMs available, the triggers were AT in 640 EGMs, VT in 76, SBR in 105, and PMT in 178 EGMs. Four EGMs were triggered by magnet application. The trigger was confirmed in 614 EGMs (62%): 62% of AT episodes, 18% of VT episodes, 100% of SBR episodes, and 54% of PMT episodes. In 385 cases (45%), the EGMs revealed false-positive events due to far-field sensing (39%), noise and myopotential sensing (26%), sinus tachycardias (21%), double counting (9%), exit block (4%), and undersensing (1%). CONCLUSION: This large-scale study of stored EGMs revealed their value in validating diagnostic counter data. Therapeutic decisions should not be based on diagnostic counters alone; they should be validated by sophisticated tools like stored EGMs.