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In vitro development of automatic control for the actively filled electrohydraulic heart.

The in vitro development of automatic control of the actively filled, alternately pumped, volumetrically coupled, electrohydraulic total artificial heart was the goal of this investigation. Control features under study were (a) cardiac output (CO) response to preload; (b) CO relationship to mean aortic pressure (AoP); and (c) control of balanced ventricular outputs. A modified pulmonic valve to increase backflow was used as a balancing mechanism. Hydraulic fluid pressure transducers monitored diastolic pressures, and microprocessor control of motor speed maintained in a mild suction to yield filling rate dependent on atrial pressure. Results indicated a rise in CO from 5 to 9 L/min, with a change in mean right atrial pressure (RAP) from 0 to 7 mm Hg. No significant difference in CO was found as AoP was varied from 80 to 120 mm Hg with a maximum variation of +/- 0.5 L/min on CO and +/- 1 mm Hg on RAP. Balance was maintained for bronchial flows up to 50% with mean left atrial pressure never exceeding 15 mm Hg. An alternately pumped electrohydraulic heart was automatically controlled to respond sensitively to preload changes. Afterload changes did not alter the CO response curve. Automatically controlled, balanced ventricular outputs were maintained.

Algorithms↗

The automatic rate adjustment pacemaker. The possibilities of rate hysteresis.

Since the first use of pacemakers there have been attempts to regulate the fixed, or basic rate of implanted pulse generators. Earlier models employed the use of magnets or percutaneous needles to change the pacemaker rate after implantation. A recent development is the programmable pacemaker, which utilizes external electromagnetic signals to alter the basic rate. A series of engineering advances have resulted in automatic pacemaker rate changes, as first embodied in the hysteresis pacemaker. Notable modifications of the basic hysteresis concept include gradual pacemaker rate changes, and variable hysteresis or rate changes dependent on electrophysiologic events. Many of these technical advances are unknown to physicians, but are disclosed in patents. In general, negative hysteresis favors emergence of underlying non-pacer rhythms, whereas positive hysteresis suppresses underlying rhythms of any type. The automatic rate adjustment pacemaker represents an attempt to derive the advantages of negative hysteresis while eliminating the disadvantages of abrupt rate changes. The unit automatically searches for a sinus rhythm slower than the basic pacing rate, by periodically gradually slowing its rate to a lower level.

Arrhythmias, Cardiac↗

The automatic implantable defibrillator. New Modality for treatment of life-threatening ventricular arrhythmias.

The automatic implantable defibrillator continuously monitors cardiac rhythm, identifies ventricular fibrillation and then delivers corrective defibrillatory discharges when indicated; it weighs 250 grams and has a volume of 145 cc. When a suitable arrhythmia is detected, a 25 Joule pulse is delivered through a superior vena cava catheter electrode and another electrode placed over the cardiac apex. As of March 1981, sixteen survivors of multiple cardiac arrests refractory to antiarrhythmic therapy had undergone implantation of the automatic defibrillator. There was no operative mortality and the morbidity was minimal. Electrophysiologic studies were performed before and after surgery to confirm failure of drug therapy and to ensure the device's ability to terminate malignant arrhythmias. Eight spontaneous and fourteen of the seventeen induced malignant arrhythmias were properly recognized and corrected by the device. The discharges were well tolerated by awake patients. A number of problems including recycling delays and spurious discharges have been identified and corrected. There were three late deaths with pulmonary edema noted in two patients, and asystole in one. The autopsies revealed no myocardial damage attributable to the automatic defibrillator. Although the ultimate role of this approach to prevention of sudden arrhythmic death has yet to be determined, the results obtained to date are encouraging and indicate that a useful modality for treating malignant ventricular arrhythmias has been added to our armamentarium.

Adolescent↗

Amiodarone for refractory automatic atrial tachycardia: observations on the electrophysiological actions of amiodarone.

A patient with automatic atrial tachycardia refractory to all conventional therapies is described. Amiodarone controlled the tachycardia by causing a progressive decrease in the rate of discharge from the atrial focus. We conclude that 1) amiodarone was effective therapy for automatic atrial tachycardia, avoiding the need for nonmedical therapy; and 2) amiodarone appeared to act by decreasing spontaneous automaticity.

Amiodarone↗

Automatic scanning extrastimulus pacemaker to treat ventricular tachycardia.

Many investigators have reported the use of various permanent pacemaking modes in the long-term management of patients with recurrent ventricular tachycardia. The three general types of antitachycardic pacemakers are: (1) underdrive; (2) burst; and (3) scanning pacemakers. Such devices have been activated externally or have had automatic activation. Each antitachycardic pacemaking modality has known technical and physiologic limitations. A serious limitation of dual-demand underdrive pacemakers is that they are usually successful only for tachycardias with a rate below 160 bpm because a random stimulus is needed for conversion. Therefore, this modality is seldom useful in patients with symptomatic sustained ventricular tachycardia in which rates are generally greater than 160 bpm and/or hemodynamic compromise occurs rapidly. Although others have reported the successful use of burst pacemakers in the control of ventricular tachycardia, this technique may cause acceleration of ventricular tachycardia and induction of ventricular fibrillation. Programmable automatic scanning pacemakers have been used successfully to treat paroxysmal supraventricular tachycardia and have been used recently in combination with antiarrhythmic agents to control ventricular tachycardia. This report outlines the use of an automatic scanning pacemaker alone for the treatment of symptomatic ventricular tachycardia in a patient who was unable to tolerate conventional antiarrhythmic medications.

Adult↗

Evaluation of global and regional left ventricular function using two-dimensional and M-mode echocardiography in patients with an automatic implantable cardioverter defibrillator.

The effects of glued epicardial patch electrodes of the automatic implantable cardioverter defibrillator on the left ventricular function was studied by two-dimensional and M-mode echocardiography in 15 patients. Pre- and postoperative end-diastolic and end-systolic left ventricular cross-sectional areas were evaluated using planimetry. Regional left ventricular wall motion at the level of the left ventricular patch electrode was analyzed by two end-diastolic and end-systolic perpendicular axes. Left ventricular end-diastolic and end-systolic diameters as well as E-point-septal-separation and fractional shortening were analyzed using M-mode echocardiography. The mean time interval between preoperative echocardiograms and implantation of the automatic defibrillator was 0.3 X 1.3 (less than 1-2) months. Postoperative echocardiograms were recorded 6.6 +/- 6.9 (0.5-24) months after implantation of the device. There were no significant differences between pre- and postoperative mean values of end-diastolic and end-systolic areas and axes as well as M-mode echocardiographic parameters. Our data show that left ventricular patch electrodes do not significantly alter global or regional left ventricular function in patients after implantation of the automatic defibrillator.

Adult↗

The use of beep-o-grams in the assessment of automatic implantable cardioverter defibrillator sensing function.

Noninvasive assessment of sensing performance in the automatic implantable cardioverter defibrillator is limited by the absence of telemetry or memory functions. The adaptation of the electrophysiological test mode into a "beep-o-gram" recording, with simultaneous audible tones and a surface electrocardiogram, was used in the confirmation of sensing malfunction. Eleven of 13 recordings in patients with documented or clinically suspected inappropriate defibrillator discharges (group 1) demonstrated evidence of definite oversensing. Nonspecific oversensing or undersensing was present in 77% of 27 randomly selected asymptomatic patients without known sensing malfunction (group 2). The sensitivity and specificity for identifying definite oversensing was 85% and 60%, respectively. The beep-o-gram system is a reliable, noninvasive means of confirming sensing malfunction in the automatic implantable cardioverter defibrillator. Its specificity is limited by the detection of subclinical sensing aberrations, to some degree related to the device's automatic gain control sensing algorithm.

Electric Countershock↗

Anxiety and anger in patients with ventricular tachyarrhythmias. Responses after automatic internal cardioverter defibrillator implantation.

In order to assess the psychological profile of patients with malignant ventricular tachyarrhythmias, eight patients who underwent implantation of the automatic internal cardioverter defibrillator for refractory arrhythmias were evaluated. Six men and two women with a mean age of 53 years were examined with the Symptom Checklist-90, the State Trait Personality Inventory and a specifically designed questionnaire about the automatic internal cardioverter defibrillator. The group studied manifested high degrees of both anger and anxiety compared to normal controls or to other medically ill populations. The trait scores remained essentially unchanged before and after the AICD implantation. The state of anxiety was markedly reduced by 26 percentage points after implantation (P less than 0.01), while the state of anger remained unchanged. In evaluating the number of AICD discharges, it was observed that the number of discharges in the first 6 months was higher than that observed in the subsequent follow-up period (mean 30 months). The reduction in AICD discharges demonstrated a trend (P = 0.094). Patient acceptance of the automatic internal cardioverter defibrillator was high. They became accustomed to the pulse generator after a mean of 3.6 months. The defibrillator permitted resumption of normal activities. If the device became battery depleted, all patients would insist on replacement. The evaluation of this group of patients with malignant ventricular arrhythmias indicates a high degree of anxiety and anger, which potentially may influence outcome. The reduction in defibrillator discharges after the first 6 months in addition to a reduced state of anxiety is a relationship that merits further investigation.

Anger↗

Reliability of an automatic sensing algorithm.

Automatic adaptation of the atrial sensitivity was evaluated in 18 patients with dual chamber pacemakers (Intermedics, Inc., Relay) in the unipolar mode. After atrial sensitivity was stabilized in the upright position, patients underwent a 1.0 W/kg body weight exercise for 5 minutes. A 24-hour Holter ECG was recorded, and the maximum and minimum atrial sensitivity values reached were stored in the memory of the pulse generator. In a second series of 12 patients, Holter ECGs were recorded twice, starting with the same sensitivity but with automatic adaptation alternately switched "on" or "off." Results of the exercise test: mean atrial sensitivity declined from 2.30 +/- 0.77 mV to 2.03 +/- 0.68 mV. There was no change in five patients, a slight increase in two patients, and lowering of the atrial sensitivity was observed in 11 patients, the difference ranging from 0.2 to 1.0 mV. A total of two P waves in two patients were missed by the atrial amplifier. The minimum and maximum sensitivity reached during Holter monitoring averaged 2.31 +/- 0.67 mV versus 1.72 +/- 0.71 mV (difference 0-1.7 mV). Normal pacemaker function was found in six patients, including one patient without any intrinsic atrial activity. Malsensing of less than five P waves occurred in four patients. More than 50 sensing defects resulted from ectopic atrial beats (four patients). We observed atrial oversensing in three cases; one patient showed atrial over- and undersensing. The comparison between fixed and variable sensitivity did not reveal any superiority of automatic adaptation.(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗

Successful radiofrequency energy ablation of automatic junctional tachycardia preserving normal atrioventricular nodal conduction.

Automatic junctional tachycardia is frequently refractory to medical management and difficult to treat with nonpharmacological methods. A 12-year-old female with symptomatic, refractory automatic junctional tachycardia is reported. Earliest atrial activation during supraventricular tachycardia was in the posterior portion of the intraatrial septum. The patient underwent electrophysiological study and successful radiofrequency current ablation of the ectopic automatic focus within the atrioventricular junction. Normal atrioventricular junctional conduction was maintained, and at 7-month follow-up the patient has been free of tachycardia.

Atrioventricular Node↗

Wide complex tachycardia due to automaticity in an accessory pathway.

Patients with the Wolff-Parkinson-White (WPW) syndrome have preexcited tachycardia as the result of atrial arrhythmias or antidromic reentry. This article describes a patient with persistent wide complex tachycardia due to abnormal automaticity in the accessory pathway. Radiofrequency catheter ablation resulted in simultaneous elimination of accessory pathway conduction and automaticity. Accessory pathway automaticity may be an infrequent cause of preexcited tachycardia in patients with the WPW syndrome.

Adolescent↗

Use of automatic mode change between DDD and AAI to facilitate native atrioventricular conduction in patients with sick sinus syndrome or transient atrioventricular block.

The benefits of the automatic DDD (DDD/AMC) mode in the Chorus II pacemaker (Chorus 6234; Ela Medical Inc.), which automatically switches the modes between DDD and AAI to respect spontaneous AV conduction as much as possible in AAI while preserving safety pacing in DDD during paroxysmal AV block (AVB) only, remain unproven. This study examined the functions of the DDD/AMC mode in 12 patients with sick sinus syndrome (SSS; n = 10) or paroxysmal complete AVB (n = 2). A short-term (24 hours) comparative study between simple DDD mode and the DDD/AMC mode was performed in 8 of the 12 patients, and a medium-term (55.2 +/- 54.6 days) follow-up of the DDD/AMC mode was completed in all 12 patients. A comparative pair of 24-hour surface Holter ECGs was obtained in 6 of the 8 patients in the short-term study. Telemetry and built-in Holter histograms were collected in the outpatient clinic in all 12 patients. Although the percentage atrial pacing of the telemetry increased from 59.2 +/- 35.4 in DDD to 70.4 +/- 31.8 in DDD/AMC (P < 0.009; n = 8), the percentage ventricular pacing decreased from 64.6 +/- 37.7 in DDD to 36.2 +/- 43.1 in DDD/AMC (P < 0.027) in the short-term study. In particular, the reduction of percentage ventricular pacing to < 10% was observed in four patients with SSS not associated with > or = first-degree (1 degree) AVB on preoperative ECGs. Between the two modes a significant difference in arrhythmic events was not observed by the 24-hour surface Holter ECGS taken from the six patients in the short-term study. AAI-DDD switching associated with automatic modulation of AV delay and AV hysteresis occurred in all patients in the medium-term study. From the medium-term study, the total AV delay (AV delay plus AV hysteresis) exceeded 300 ms in 6 of the 12 patients in DDD/AMC, and usually became longest during nighttime. From the short- or medium-term study in the 12 patients, two patients preferred the DDD/AMC mode while one preferred the DDD mode. These results suggest that the DDD/AMC mode is useful, at least in SSS patients without > or = 1 degree AVB, by reducing the percentage ventricular pacing.

Adult↗

Inhibition of bradycardia pacing caused by far-field atrial sensing in a third-generation cardioverter defibrillator with an automatic gain feature.

The diagnostic accuracy of implantable cardioverter defibrillators may be improved by automatically adjusting gain algorithms, which in general reduce the likelihood of oversensing while maintaining the ability to detect the low amplitude signals associated with ventricular fibrillation. We present a patient with a third-generation device who developed prolonged ventricular asystole arising as a complication of the automatic gain feature. During asystole the device automatically increased sensitivity in order to prevent undersensing of ventricular fibrillation, which in this case resulted in far-field sensing of atrial activity and inhibition of ventricular pacing.

Aged↗

Initial clinical experience with a fully automatic in-hospital external cardioverter defibrillator.

Sudden cardiac death due to ventricular tachyarrhythmia remains a significant problem in the in-hospital setting. Although the probability of survival is closely correlated with the rapidity of a response by qualified personnel, response times can be prolonged, even in specialized care units. In an effort to decrease response time, a fully automatic external cardioverter defibrillator was recently devised. This device was evaluated in the in-hospital setting to assess safety and efficacy. A total of 79 patients were studied in a multicenter trial. Patients were monitored with fully functional devices in the electrophysiology laboratory (51 patients) and in the cardiac care unit (28 patients). Performance of the device was assessed by comparing automatic responses to any sustained change in cardiac rhythm, either spontaneous or induced, to a retrospective review of stored ECG data and programmed parameters. During a total duration of 964 hours of monitoring, there were 99 episodes of sustained tachycardia. Therapy was appropriately delivered or advised in all episodes. Therapy was advised in one episode of supraventricular tachycardia. There were no episodes of inappropriate therapy delivery. There were no complications or adverse events. The device performed with a sensitivity of 100% and specificity of 98.8% with an average response time of 22 seconds. In conclusion, this automatic external defibrillator was safe, effective, and functioned as designed. Significant improvement in response time to life-threatening ventricular tachyarrhythmia in the in-hospital setting would be expected if this technology was widely adopted.

Adult↗

Pacing threshold trends and variability in modern tined leads assessed using high resolution automatic measurements: conversion of pulse width into voltage thresholds.

With the aid of an algorithm for automatic pacing threshold (T) measurement in the atrium and ventricle, downloadable into implanted Thera pacemakers (Medtronic Inc.), we studied T evolution during lead maturation, T variation during activities of daily living, and various types of beat-to-beat T variations in three tined bipolar leads: 5.6-mm2 steroid-eluting (Medtronic Inc. models 4524 atrial-J [n = 8] and 4024 ventricular [n = 8]), 1.2-mm2 steroid-eluting (Medtronic Inc. models 5534 atrial-J [n = 9] and 5034 ventricular [n = 9]), and 8-mm2 without steroid (Intermedics models 432-04 atrial-J [n = 7] and 430-10 ventricular [n = 7]). The leads were implanted in 24 consecutive patients with intact AV conduction (required by the algorithm) and followed for up to 13-25 months after implantation. Since the algorithm determined pulse width Ts at different amplitudes that, depending upon T level, could range from 0.5 to 5.0 V, we invented a methodology for conversion of pulse width Ts into voltage Ts at 0.5 ms, to pool and present T data on a universal scale. Frequent, high resolution T measurements revealed details on the lead maturation process that we divided into three stages: initial T subsiding, first wave of T peaking, and a new, quicker or slower, T rise. Although there were notable differences in duration and magnitude of T peaking on the individual basis, differences between the three lead types and between the atrium and ventricle were demonstrable. The 1.2-mm2 leads exhibited less T peaking than their predecessors 5.6-mm2 leads and excellent positional stability, whereas 8-mm2 leads demonstrated the most intensive T peaking and highest mean chronic T values. T changes during activities of daily living showed some tendencies-higher T during night and lower T during exercise--yet with a number of exceptions. The overall magnitude of daily T fluctuations was < 0.2 V in all but one lead, and 50% daily voltage safety margin would be sufficient. A 100% voltage safety margin may be inadequate for a 1-year period during the chronic phase (after 6 months of implantation). A scheme for calculation of pulse width safety margins equivalent to voltage safety margins is given. Some leads can exhibit very large beat-to-beat T variations before, during, and after T peaking, and prospective algorithms for automatic T measurement should verify T values through more than 1-2 captured beats to obviate a great underestimation of the T providing consistent capture. T dependence upon pacing rate was negligible. Consistent-capture hysteresis may, in conjunction with lead instability, be as much as 0.25 V. Therefore, it is better to use an incremental approach from below to T level during automatic T measurements.

Activities of Daily Living↗

Reflex autonomic modulation of automatically measured repolarization parameters.

Automatic recognition of repolarization abnormalities from the standard electrocardiogram (ECG) is of considerable clinical importance. This study examined the autonomic variations in automatically measured repolarization parameters, including maximum QT interval (QTmax), global QT dispersion (QTd), T area dispersion (T area D) and principal component analysis ratio 2 (PCA-2). Twelve-lead ECGs were recorded continuously in 40 healthy subjects during supine, sitting and standing positions, and during the Valsalva maneuver. With the exception of PCA-2, the other repolarization parameters correlated either moderately or strongly during the steady-state supine position. QTmax, PCA-2, and T area D decreased significantly between supine and sitting position (P < 0.001, P < 0.001 and P < 0.01, respectively). QTmax, QTD, and T area D decreased significantly between sitting and standing (P < 0.001, P < 0.05 and P < 0.01, respectively). All parameters significantly decreased between supine and standing position: QTmax (P < 0.001), QTD (P < 0.05), PCA-2 (P < 0.05) and T area D (P < 0.001). During Valsalva, only PCA-2 increased significantly (P < 0.001) between supine and standing position. There were no significant changes in QT dispersion and dispersion of T wave area during Valsalva, compared to baseline, in both supine and standing positions. Automatic conventional measures of repolarization heterogeneity have limited practical value in detecting the effects of autonomic changes on ventricular repolarization. Newer concepts evaluating spatial and temporal irregularity of ventricular repolarization are still needed to reliably detect the effects of autonomic activity on ventricular repolarization.

Adolescent↗

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.

Adult↗

Automatic ventricular threshold measurement in children with epicardial pacing leads.

BACKGROUND: The aim of the study was to evaluate the safety and reliability of automatic ventricular pacing threshold measurement, the Medtronic Capture Management (CM), in children with epicardial pacing leads. CM has not been recommended for use with epicardial leads due to lack of pertinent data. METHODS: During a 2-year study period, 34 children (mean age 6.1 years, range 0 days to 17.7 years) with epicardial leads were prospectively enrolled. The CM measurements were compared with in-office ventricular pacing threshold measurements. Thirty bipolar and five unipolar epicardial leads were assessed. RESULTS: CM measurements were successful and reliable in 30 out of 35 leads (86%). The mean threshold with CM was 1.16 V (95% CI 1.07-1.26 V), and with standard measurement was 1.18 V (95% CI 1.09-1.28 V), at a pulse width of 0.40 ms. The reasons for failure were evoked response undersensing in two cases (5.7%), and high intrinsic rate in one case. High pacing thresholds prevented accurate CM measurements in two cases. CONCLUSIONS: CM automatic threshold measurements are consistent with standard ventricular pacing threshold measurements in children with epicardial leads. We recommend a period of monitoring CM performance before programming it to adjust output according to automatic threshold measurements, in order to find the patients in whom it does not work. The CM feature provides increased pacing safety when it measures well (86% of leads). A larger study is needed to prove the tendency for extending battery life in children with epicardial leads.

Adolescent↗