Evoked Response Signals Research Articles

Muscle Noise Effects on Atrial Evoked Response Sensing: Implications on Atrial Auto-Threshold and Auto-Capture Determination

Automatic pacing capture verification algorithms that are based on detection of local evoked response signals are susceptible to interference from myopotential noise. This is especially true in the atrium where the lower signal amplitude and signal-to-noise ratio make pacing capture verification more challenging. The aim of this study is to evaluate the impact of myopotential noise induced by various maneuvers on the atrial evoked response (AER) signal. Data were collected from 18 patients (7 M/11 F, 77.6 ± 8.8 years), implanted with a dual chamber rate response (DDDR) pacemaker and acute and chronic right atrial leads and right ventricular leads, at three regular follow-up visits scheduled at 1, 3, and 6 months after pacemaker implantation or replacement procedures. During each study visit, manual atrial pacing threshold tests during unipolar pacing in the DDD mode were conducted with two evoked response sensing configurations (RA(Ring) → Ind and RA(Ring) → V(Tip) ) while patients performed six different maneuvers. Noise estimates were calculated for each maneuver. The greatest noise estimates in both sensing configurations were measured during the hand-pressing exercise (0.649 ± 0.342 mV in the RA(Ring) → Ind vector, 0.309 ± 0.223 mV in the RA(Ring) → V(Tip) vector). No significant differences in overall noise estimates were observed between the follow-up visits. Of the beats that exhibited noise estimates greater than a sensing floor of 0.3 mV, up to 22% of cardiac beats had a signal-to-noise ratio less than 2 in the RA(Ring) → Ind configuration. Results indicate that myopotential noise generated by performing maneuvers has a demonstrable impact on AER sensing. Therefore, noise mitigation processes are necessary in atrial automatic pacing capture verification algorithms based on evoked response signals to identify and appropriately manage noise.

Performance Evaluation of a Right Atrial Automatic Capture Verification Algorithm using Two Different Sensing Configurations

This acute data collection study evaluated the performance of a right atrial (RA) automatic capture verification (ACV) algorithm based on evoked response sensing from two electrode configurations during independent unipolar pacing. RA automatic threshold tests were conducted. Evoked response signals were simultaneously recorded between the RA(Ring) electrode and an empty pacemaker housing electrode (RA(Ring)-->Can) and the electrically isolated Indifferent header electrode (RA(Ring)-->Ind). The atrial evoked response (AER) and the performance of the ACV algorithm were evaluated off-line using each sensing configuration. An accurate threshold measurement was defined as within 0.2 V of the unipolar threshold measured manually. Threshold tests were designed to fail for small AER (< 0.35 mV) or insufficient signal-to-artifact ratio (SAR < 2). Manual threshold measurements were obtained during RA unipolar and bipolar pacing and compared across device indications. Data were collected from 38 patients with RA bipolar leads from four manufacturers. AER signals were analyzed from 34 patients who were indicated for a pacemaker (five), implantable cardioverter-defibrillator (11), or cardiac resynchronization therapy pacemaker (six) or defibrillator (12). The minimum AER amplitude was larger (P < 0.0001) when recorded from RA(Ring)-->Can (1.6+/-0.9 mV) than from RA(Ring)-->Ind (1.3+/-0.8 mV). The algorithm successfully measured the pacing threshold in 96.8% and 91.0% of tests for RA(Ring)-->Can and RA(Ring)-->Ind, respectively. No statistical difference between the unipolar and bipolar pacing threshold was observed. The RA(Ring)-->Can AER sensing configuration may provide a means of implementing an independent pacing/sensing method for ACV in the RA. RA bipolar pacing therapy based on measured RA unipolar pacing thresholds may be feasible.

Long-term experience with AutoCapture®-controlled epicardial pacing in children

To examine the feasibility and safety of AutoCapture (AC)-controlled pacing with epicardial leads in children, and study the effects on device longevity. A total of 62 children were prospectively enrolled. Pre-discharge testing precluded AC function in six children. In 56 (90%) children, devices with AC-controlled pacing were followed up to 9years. Calculated battery life in AC-controlled pacing was compared with theoretical calculations, using a two-fold stimulation output of measured thresholds. In 53 of 56 children, no differences were observed for evoked response signals (13.3 vs. 11.5mV, P = 0.20) or lead polarization safety margins (5.5 vs. 4.1, P = 0.25) at 6-month and 4-year follow-up. A crossover to conventional pacing was required in 3 of 56 children. AC-controlled pacing prolonged the calculated battery life up to 15% for the identity and integrity devices with 0.95A h capacity, compared with theoretical conventional settings (P = 0.008). In patients with ventricular pacing thresholds >1.5V at 0.5ms, battery life was increased by 30% compared with theoretical conventional settings (P < 0.001). AC-controlled pacing with epicardial leads is feasible and safe in children during long-term follow-up. An adequate lead polarization safety margin persists in most patients. Calculated battery life was prolonged up to 15% with AC-controlled pacing. Patients with high or fluctuating pacing thresholds benefit the most.

A MEMS fabricated flexible electrode array for recording surface field potentials

We developed a method to microfabricate flexible electrode arrays on a thin Kapton substrate, which was engineered to minimize trauma when inserted between the dura and skull to obtain surface EEG recordings. The array consisted of 64 gold electrodes, each 150 μm in diameter on a 750 μm spaced 8 × 8 grid. Using photolithographic procedures, any arrangement of electrodes can be implemented. We used the electrode array to record evoked response signals to create topographical maps of the whisker barrels on the cortical surface with excellent signal stability over a period of 8 h. The materials used for this fabrication are potentially biologically inert and, with some additional modifications to the design, can be chronically implanted with minimal side effects. Retinal prosthesis, human neurosurgery, and neurological research are all limited to some degree by the resolution and biological compatibility of the implants used. This type of array could greatly enhance the spatial resolution, signal quality, and stability of implantable surface electrode arrays.

An Algorithm for Verifying Biventricular Capture Based on Evoked‐Response Morphology

Cardiac resynchronization therapy relies on consistent beat-by-beat myocardial capture in both ventricles. A pacemaker ensuring right (RV) and left ventricular (LV) capture through reliable capture verification and automatic output adjustment would contribute to patients' safety and quality of life. We studied the feasibility of an algorithm based on evoked-response (ER) morphology for capture verification in both the ventricles. RV and LV ER signals were recorded in 20 patients (mean age 72.5 years, range 64.3-80.4 years, 4 females and 16 males) during implantation of biventricular (BiV) pacing systems. Leads of several manufacturers were tested. Pacing and intracardiac electrogram (IEGM) recording were performed using an external pulse generator. IEGM and surface-lead electrocardiogram (ECG) signals were recorded under different pacing conditions for 10 seconds each: RV pacing only, LV pacing only, and BiV pacing with several interventricular delays. Based on morphology characteristics, ERs were classified manually for capture and failure to capture, and the validity of the classification was assessed by reference to the ECG. A total of 3,401 LV- and 3,345 RV-paced events were examined. In the RV and LV, the sensitivities of the algorithm were 95.6% and 96.1% in the RV and LV, respectively, and the corresponding specificities were 91.4% and 95.2%, respectively. The lower sensitivity in the RV was attributed to signal blanking in both channels during BiV pacing with a nonzero interventricular delay. The analysis revealed that the algorithm for identifying capture and failure to capture based on the ER-signal morphology was safe and effective in each ventricle with all leads tested in the study.

Clinical experience with an automatic threshold tracking algorithm study.

The automatic threshold tracking pacing system algorithm developed by St. Jude Medical, verifies ventricular capture beat by beat by recognizing the evoked response (ER) following each pacemaker stimulus. The present automatic threshold tracking function requires a bipolar ventricular lead with low polarization. The aim of this study was to evaluate a new algorithm developed to use with unipolar leads with different levels of polarization. An external pacemaker with the ability to sense intrinsic R waves and measure ER signals, as well as deliver stimulus, was used. An algorithm for detecting the true ER in a unipolar sensing configuration (tip-case) was developed. Based on the assumption that the true evoked R wave amplitude is independent of the stimulation amplitude, the algorithm calculates and subtracts the polarization present at any pacing stimulus from the measured ER. The resulting signal is analyzed to verify capture. This study comprises 35 patients of which 26 were new implants and 9 had chronic leads. The automatic threshold-tracking algorithm was calibrated for each patient and pacing was performed at different pulse amplitudes and pulse duration. Capture was verified for each paced beat. The recordings were stored for later comparison with the tape-recorded intracardiac heart signals. The new algorithm correctly verified capture or loss of capture for every single analyzed beat at the different pacing outputs in every individual patient. The results from this initial study suggests that the new ER detection principle will allow automatic threshold tracking to be used not only with low polarization bipolar leads but with most leads.

Automatic capture verification in ICD lead systems using intracardiac ventricular evoked response and reduced coupling capacitance.

Intracardiac ventricular evoked-response (ER) signals detected by implanted cardioverter defibrillator (ICD) lead systems were investigated for automatic capture verification (AC). ER signals were evaluated with an external pacing system equipped with a reduced coupling capacitance (CC=2.2 microF) in the pacing output circuit during ventricular step-down threshold testing at 0.4 ms pulse duration. Real-time pacing markers, surface ECG and intracardiac electrograms pre- and post-filtering were digitally recorded. Twenty consecutive patients, age 61+/-12 years, with leads from two different manufacturers were tested - 10 were implanted with acute leads (AL) and 10 with chronic leads (CL). The analysis was based on the ER amplitude during capture and on the ER-to-afterpotential ratio (SAR), with SAR>2 as the criterion for successful capture detection. ER amplitudes (median and range) were 8.1 mV (2.1-19.5 mV) for AL and 8.3 mV (3.7-14.2 mV) for CL. SAR values (median and range) were 48.0 (2.5-682.6) for AL and 13.2 (6.3-35.9) for CL, indicating that AC could successfully be applied in all patients. Reducing the pacing CC allows adequate ER detection for automatic capture verification on non-selected ICD lead systems. The effect of high-voltage shock treatment on ER signal detection requires further investigation.

Reduction of pacing output coupling capacitance for sensing the evoked response.

Sensing of the intracardiac evoked response (ER) after a pacing stimulus has been used in implantable pacemakers for automatic verification of capture. Reliable detection of ER is hampered by large residual afterpotentials associated with pacing stimuli. This led to the development of various technological solutions, like the use of triphasic pacing pulses and low polarizing electrode systems. This study investigated the effect of reducing the coupling capacitance (CC) in the pacemaker output circuitry on the magnitude of afterpotential, and the ability to automate detection of ventricular evoked response. A CC of 2.2 microF and four different blanking and recharge time settings were clinically tested to evaluate its impact on sensing of the ventricular ER and pacing threshold. Using an automatic step-down threshold algorithm, 54 consecutive patients, aged 70 +/- 10 years with acutely (n = 27) or chronically (n = 27) implanted ventricular pacing leads were enrolled for measurement testing. Routine measurements, using a standard pacing system analyzer (PSA), were (mean +/- SD) impedance 569 +/- 155 omega, R wave amplitude baseline to peak 9.8 +/- 3.7 mV and threshold 0.9 +/- 0.7 V at 0.4-ms pulse width. This new capture verification scheme, based on a CC of 2.2 microF and recharge/blanking timing setting of 10/12 ms, was successful in 52 patients which is equivalent to a success rate of 96%. In a subgroup of 26 patients implanted with bipolar ventricular leads (10 chronic, 16 acute), data were collected in unipolar (UP) and bipolar (BP) pace/sense configurations. Also, ER signals were recorded with two different band-pass filters: a wider band (WB) of 6-250 Hz and a conventional narrow band (NB) of 20-100 Hz. WB sensing from UP lead configuration yielded statistically significant larger signal to artifact ratios (SAR) than the other settings (P < 0.01). A dedicated unipolar ER sensing configuration using a small output capacitor and a wider band-pass filter enables adequate automatic capture verification, without any restrictions on pacing lead models or pacing/sensing configurations.

Intraoperative study of polarization and evoked response signals in different endocardial electrode designs.

Some new generation pacemakers use an algorithm based on evoked response (ER) detection to verify beat-to-beat capture and to enable automatic adjustment of output. This is a prospective acute study of polarization signal (PS) and ER in nine currently available electrodes. Intraoperative testing of ventricular bipolar electrodes used the Autocapture (AC) algorithm. The intrinsic R wave, PS, ER, acceptance of AC function, and stimulation thresholds (STs) were obtained. Ventricular electrodes were categorized as follows: titanium nitride (TiN)-coated passive and active fixation, high impedance (HI), passive fixation (VP), iridium oxide-coated titanium (IROX) (VI), and platinum helix (PH) active fixation. Acute testing was performed in 217 patients with an average age of 74.26 years, 59.6% were men with primary pacing indication-SSS (46.3%). There were no significant differences found with respect to R wave and threshold between the various electrodes. PH active-fixation electrodes had significantly higher ER and PS than other groups including the TiN-coated active-fixation electrodes. TiN-coated electrodes (active and passive fixation) had significantly lower PS than other electrodes. As a result, TiN electrodes had a significantly higher functional rate of AC (91.7%), whereas PH had the lowest rate (0%). In conclusion, (1) polarization characteristics are significantly different for commercially available ventricular electrodes, (2) certain physical features at the tissue to electrode interface like TiN coating appears to be more important in determining PS than electrode tip size and fixation method, and (3) the current algorithm for AC requires electrodes that provide low polarization for satisfactory performance.

Enhanced brainstem and cortical evoked response amplitudes: single-trial covariance analysis.

The purpose of the present study was to develop analytic procedures that improve the definition of sensory evoked response components. Such procedures could benefit all recordings but would especially benefit difficult recordings where many trials are contaminated by muscle and movement artifacts. First, cross-correlation and latency adjustment analyses were applied to the human brainstem frequency-following response and cortical auditory evoked response recorded on the same trials. Lagged cross-correlation functions were computed, for each of 17 subjects, between single-trial data and templates consisting of the sinusoid stimulus waveform for the brainstem response and the subject's own smoothed averaged evoked response P2 component for the cortical response. Trials were considered in the analysis only if the maximum correlation-squared (r2) exceeded .5 (negatively correlated trials were thus included). Identical correlation coefficients may be based on signals with quite different amplitudes, but it is possible to assess amplitude by the nonnormalized covariance function. Next, an algorithm is applied in which each trial with negative covariance is matched to a trial with similar, but positive, covariance and these matched-trial pairs are deleted. When an evoked response signal is present in the data, the majority of trials positively correlate with the template. Thus, a residual of positively correlated trials remains after matched covariance trials are deleted. When these residual trials are averaged, the resulting brainstem and cortical responses show greatly enhanced amplitudes. This result supports the utility of this analysis technique in clarifying and assessing evoked response signals.

ENHANCED BRAINSTEM AND CORTICAL EVOKED RESPONSE AMPLITUDES: SINGLE-TRIAL CO VARIANCE ANALYSIS

The purpose of the present study was to develop analytic procedures that improve the definition of sensory evoked response components. Such procedures could benefit all recordings but would especially benefit difficult recordings where many trials are contaminated by muscle and movement artifacts. First, cross-correlation and latency adjustment analyses were applied to the human brainstem frequency-following response and cortical auditory evoked response recorded on the same trials. Lagged cross-correlation functions were computed, for each of 17 subjects, between single-trial data and templates consisting of the sinusoid stimulus waveform for the brainstem response and the subject's own smoothed averaged evoked response P2 component for the cortical response. Trials were considered in the analysis only if the maximum correlation-squared (r2) exceeded .5 (negatively correlated trials were thus included). Identical correlation coefficients may be based on signals with quite different amplitudes, but it is possible to assess amplitude by the nonnormalized covariance function. Next, an algorithm is applied in which each trial with negative covariance is matched to a trial with similar, but positive, covariance and these matched-trial pairs are deleted. When an evoked response signal is present in the data, the majority of trials positively correlate with the template. Thus, a residual of positively correlated trials remains after matched covariance trials are deleted. When these residual trials are averaged, the resulting brainstem and cortical responses show greatly enhanced amplitudes. This result supports the utility of this analysis technique in clarifying and assessing evoked response signals.

Hierarchical fuzzy-based support system for anaesthesia monitoring and control

Describes research into a hierarchical architecture for fuzzy logic monitoring and control of intravenous anaesthesia with two main objectives. The primary task is to utilise auditory evoked response signals for augmenting cardiovascular and body function signs into a multisensor fuzzy model-based fusion strategy for anaesthesia monitoring and control. The secondary task is to extend an existing fuzzy patient model for use as a training simulator via computer-based models. This demonstrates a totally fuzzy-logic-based architecture for manipulating complex procedures on a complex process (i.e. hospital patients).