Biomedical subjects
Publications and source records attributed to D J Lang.
Present adaptive-rate pacemakers use a range of sensors for implementation in open-loop and closed-loop control systems. Hemodynamic sensors that detect the mechanical action of the heart and blood flow offer additional features to implement physiologic rate adaption in rate-controlling systems and rate-limiting systems. Examples of 2 such sensors are presented.
BACKGROUND: Preoxygenation before tracheal intubation is intended to increase oxygen reserves and delay the onset of hypoxemia during apnea. Various systems are used for preoxygenation. Designed specifically for preoxygenation, the NasOral system uses a small nasal mask for inspiration and a mouthpiece for exhalation. One-way valves in the nasal mask and the mouthpiece ensure unidirectional flow. This investigation compares the efficacy of preoxygenation using the standard circle system with the NasOral system and five different resuscitation bags. METHODS: Twenty consenting, healthy volunteers were studied in the supine position for 5-min periods of tidal volume breathing using the circle absorber system, the NasOral system, and five resuscitation bags in a randomized order. Data were collected during room air breathing and at 30-s intervals during 5 min of oxygen administration. Inspired oxygen, end-tidal oxygen, and end-tidal nitrogen were measured by mass spectrometry. RESULTS: At 2. 5 min of oxygenation, end-tidal oxygen plateaued at 88.1 +/- 4.8 and 89.3 +/- 6.4% (mean +/- SD) for the circle absorber and NasOral systems, respectively. This was associated with inverse decreases in end-tidal nitrogen. At no time did these end-tidal oxygen or nitrogen values differ from each other. Three of the resuscitation bags (one disk type and two duck-bill type with one-way exhalation valves) delivered inspired oxygen more than 90%, and the end-tidal oxygen plateaued between 77 and 89% at 2 min of tidal volume breathing. The other two resuscitation bags (both duck-bill bags without exhalation valves) delivered inspired oxygen less than 40%, and the end-tidal oxygen values ranged between 21.8 +/- 5.0 and 31.9 +/- 8.7%. CONCLUSIONS: The circle absorber and NasOral systems were equally effective in achieving maximal preoxygenation during tidal volume breathing. Resuscitation bags differed markedly in effectiveness during preoxygenation; those with duck-bill valves without one-way exhalation valves were the least effective. Thus, the use of these bags should be avoided for preoxygenation.
The implantable cardioverter defibrillator (ICD), a primary therapeutic option for preventing sudden cardiac death, has rapidly evolved since being introduced clinically in 1980. Technologic advances in several key areas have enabled ICDs to provide more sophisticated rhythm management. Recent emphasis has been placed on dual-chamber ICDs possessing adaptive-rate pacing capabilities. Adoption of dual-chamber ICD systems has been rapid. The capabilities of future ICD systems will be governed by an integrative strategy that brings together sets of features specifically targeted at multifaceted rhythm disorders. The addition of atrial therapy will require more sophisticated rhythm discrimination algorithms. ICD technology will improve on several fronts including leads, integrated circuits, batteries, and capacitors. Additionally, state-of-the-art pacemaker technology will continue to be incorporated into ICDs. As these new ICD systems become increasingly sophisticated from an engineering viewpoint, tremendous emphasis will be placed on decreasing the complexity of programming, device interrogation, and patient monitoring during routine patient follow-up. Vast improvements in ICD programming systems may ultimately permit the 1-minute follow-up.
Since the first fixed-rate ventricular pacemaker was introduced in the late 1950s, pacing systems have evolved rapidly. Current developments focus on making devices more sophisticated and less complex--a challenging combination. Automaticity features such as beat-by-beat capture verification, sensitivity threshold adaptation, and algorithms to govern dynamically the maximum sensor rate have either recently been introduced or are likely to be introduced in the near future. Technologic advances are likely to allow meaningful improvements in current drain, battery performance, memory capacity, signal processing, telemetry, and programmer interface. Bradyarrhythmia therapy devices of the future promise to go beyond the pacemaker. Ultimately, pacing systems will become part of integrated cardiac rhythm management systems.
Inappropriate therapies delivered by implantable cardioverter defibrillators (ICDs) for supraventricular arrhythmias remain a common problem, particularly in the event of rapidly conducted atrial fibrillation or marked sinus tachycardia. The ability to differentiate between ventricular tachycardia and supraventricular arrhythmias is the major goal of discrimination algorithms. Therefore, we developed a new algorithm, SimDis, utilizing morphological features of the shocking electrograms. This algorithm was developed from electrogram data obtained from 36 patients undergoing ICD implantation. An independent test set was evaluated in 25 patients. Recordings were made in sinus rhythm, sinus tachycardia, and following the induction of ventricular tachycardia and atrial fibrillation. The arrhythmia complex is defined as wide if the duration is at least 30% greater than the template in sinus rhythm. For narrow complexes, four maximum and minimum values were measured to form a 4-element feature vector, which was compared with a representative feature vector during normal sinus rhythm. For each rhythm, any wide complex was classified as ventricular tachycardia. For narrow complexes, the second step of the algorithm compared the electrogram with the template, computing similarity and dissimilarity values. These values were then mapped to determine if they fell within a previously established discrimination boundary. On the independent test set, the SimDis algorithm correctly classified 100% of ventricular tachycardias (27/27), 98% of sinus tachycardias (54/55), and 100% of episodes of atrial fibrillation (37/37). We conclude that the SimDis algorithm yields high sensitivity (100%) and specificity (99%) for arrhythmia discrimination, using the computational capabilities of an ICD system.
BACKGROUND: A previous retrospective study by our group suggested that shocks timed to the upslope of the shocking lead electrogram improved defibrillation efficacy. The goal of this study was to prospectively determine whether defibrillation threshold could be reduced by use of an algorithm that timed shocks to the upslope of coarse ventricular fibrillation (test treatment) compared with shocks delivered asynchronously after 10 seconds of fibrillation (control treatment). METHODS AND RESULTS: Ten pigs were instrumented with a 3-lead system for internal defibrillation. Initial estimates of the energy required to achieve defibrillation E50 for both treatments were made by an up/down method. Subsequently, additional shocks at V50+/-10% and V50-20% were given for each treatment to obtain data points at higher and lower intensities. Probability-of-success curves were estimated for both treatments by the best-fit method. Energies required were significantly lower for the timed shocks than for the asynchronous shocks (P<0.00 1). E80 was reduced 15.5%, from 27.1+/-2.5 to 22.9+/-1.8 J (P<0.002). The width of the probability-of-success curve (E80-E20) for the test treatment was also significantly narrower than that for the control treatment (7.1+/-0.9 versus 10.8+/-1.7, P<0.01). Normalized curve width (E80-E20)/E50 was decreased from 51+/-5% of E50 for control shocks to 37+/-4% of E50 for synchronous shocks (P<0.02). CONCLUSIONS: In this model, defibrillation threshold is lower and more deterministic when shocks are timed to the upslope of the shocking lead electrogram. If a similar reduction is observed in humans, shock timing may lower defibrillation threshold and simplify programming of shock intensity.
Previous studies suggested that time periods exist during ventricular fibrillation when defibrillation shocks are more effective. However, there is no agreement on the amount of energy that can be saved or whether an implantable defibrillator can time shocks to these time periods. We conducted a study having two parts to investigate if there was any advantage to synchronizing internal defibrillation shocks to morphological patterns in ventricular fibrillation (VF). VF electrograms were recorded from the same three-electrode lead system used for internal defibrillation. In Part 1, we found no difference in the probability of successful defibrillation between shocks that were delivered into coarse and fine VF (48% vs 46%). However, shocks that were delivered to the upslope of coarse VF electrograms were more efficacious than those to the downslope of the waveform (67% vs 39%, P < .001). In the second study, we developed a real time computer system to prospectively deliver shocks on the upslope feature we identified in the first study. We found that the energy requirements at E50 and E80 were significantly lower for shocks delivered on the upslope of coarse VF than those delivered randomly at the end of 10 sec. We estimated a probability of success (POS) defibrillation curve using a maximum likelihood method for the timed and random shocks. The POS curve width was significantly narrower for shocks that were delivered to the upslope feature than the control treatment (7.1 +/- 0.9 vs. 10.8 +/- 1.7 J, P < 0.01). If these findings extend to clinical defibrillation, they may allow programming of internal defibrillators at lower energies. This could reduce potential postshock cardiac dysfunction, allow production of smaller devices, and improve battery life.
The goal of this study was to determine whether delivering transvenous defibrillation shocks, coordinated with the up/down-slope VF waveform patterns in the shocking lead, would improve the probability of successful defibrillation. Anesthetized swine (32-38 kg, n = 8) were implanted with an RV-->SVC + SQArray transvenous system to measure VF waveform patterns and to deliver shocks. The shocks were generated by a Cardiac Pacemakers Inc. biphasic waveform generator. Energy required for 50% success probability (E50) was determined using the multishock up-down protocol. VF was repeatedly induced and defibrillation shocks at E50 were given after 10 seconds. The defibrillation outcome, delivered energy (Ed), peak voltage (V), peak current (I), system impedance (Z) and VF waveform pattern at the time of shock were recorded and measured. Out of a total of 685 shocks, 324 (47%) succeeded and 361 (53%) failed. The Ed, V, I, and Z were similar for the two defibrillation outcome groups (success or failure). VF patterns were classified as high or low amplitude at the time of the shock based on the peak-to-peak amplitude of signals recorded between the shocking electrodes. Shocks that coincided with high amplitude VF patterns were further divided into shocks that occurred on the up-slope or on the down-slope. The probability of success when the E50 shocks were coincident with high or low amplitude fibrillation did not differ significantly (Student's t-test: 46% vs 48%. P = NS). However, during high amplitude fibrillation, shocks delivered on the up-slope were significantly more successful than those delivered on the down-slope (Chi-square: 67% vs 39%; P < 0.001). These results suggest that delivering defibrillation shocks during the up-slope of the high amplitude signal in the shocking lead may improve the probability of successful defibrillation of ICDs.
The implantable cardioverter-defibrillator (ICD) has evolved rapidly since its clinical introduction; product life cycles have been exceedingly short. This swift transition from early shock-only devices to small, programmable, tiered-therapy systems has been driven by 2 major factors: minimally invasive implant procedures and technological innovation. Yet, while many new ICD systems have been introduced recently, even more advanced products are on the horizon before the year 2000 and beyond. In general, devices will be smaller and smarter. Certainly, ICD volume will be further reduced without detrimentally affecting longevity. Endocardial lead systems will become smaller and more versatile. Rhythm discrimination algorithms will become more effective. New adaptive-rate pacing systems that limit the maximum paced rate based on hemodynamic indices will become features of tachyarrhythmia products. Pacing schemes for prevention of supraventricular tachyarrhythmias and improvement of hemodynamic function in patients with congestive heart failure will likely be introduced for clinical evaluation.
BACKGROUND: This study was designed to determine the incidence of false-negative and false-positive results when the self-inflating bulb (SIB) is used to differentiate tracheal from esophageal intubation in morbidly obese patients using two techniques. In technique 1, the SIB is compressed before it is connected to the tube; in technique 2, the SIB is compressed after connection to the tube. METHODS: With institutional review board approval, 54 consenting adult morbidly obese patients (body mass index > 35) undergoing elective surgical procedures were included in the study. After anesthetic induction and muscle relaxation, both the trachea and esophagus were intubated under direct vision with identical cuffed tubes. The efficacy of the SIB in verifying the position of both tubes was tested by a second anesthesiologist. The speed of reinflation was graded as rapid ( < 4 s) or none ( > 4 s), using both techniques. In the case of tracheal intubation, the absence of reinflation was recorded as a false-negative, whereas in cases of esophageal intubation, rapid reinflation was recorded as a false-positive. Identification of tube location by the second anesthesiologist was based on SIB reinflation results from techniques 1 and 2, as well as the presence of a flatuslike sound elicited by technique 2 in esophageally placed tubes. All patients were retested by the SIB after receiving three breaths of 400-500 ml each. In all patients exhibiting false-negative results, six obese patients exhibiting true-positive results, and four nonobese patients exhibiting true-positive results, tracheal responses to the SIB maneuvers were observed directly by a flexible fiberoptic bronchoscope incorporating an airtight system, 15-20 min after mechanical ventilation was instituted. RESULTS: The incidence of false-negative results was initially 30% with technique 1 and 11% with technique 2, but decreased to 4% when technique 2 was used after the delivery of three breaths. The second anesthesiologist initially identified tube location in 92.5% of patients correctly. After the delivery of three breaths, tube location was correctly identified in 96.3% of patients. Fiberoptic bronchoscopic examination of the patients exhibiting false-negative results revealed exaggerated inward bulging of the posterior tracheal membrane during reinflation of the SIB when technique 1 was used. CONCLUSIONS: Contrary to previous investigations in healthy patients, the current study demonstrates a high incidence of false-negative results when the SIB is used to confirm tracheal intubation in morbidly obese patients. If the SIB is used, the technique should include compression of the SIB after connection to the tube and should be used in conjunction with other clinical signs and technical aids. The mechanism of false-negative results in these patients seems to be related to reduction of caliber of airways secondary to a marked decrease in functional residual capacity, and collapse of large airways due to invagination of the posterior tracheal wall when sub-atmospheric pressure is generated by the SIB.
Mechanisms determining temporal lobe structural asymmetries may be involved in the pathogenesis of schizophrenia. To investigate the temporal lobes in familial schizophrenia, computed tomographic scans were obtained from 51 subjects (seven families). Enlargement of sylvian fissures and temporal lobe sulcal spaces was observed in family members with schizophrenia. The posterior one-third of the sylvian fissure was larger on the left side in subjects with schizophrenia, and larger on the right side in unaffected individuals. This disturbed pattern of posterior sylvian fissure asymmetry suggests that adjacent language regions may be affected in schizophrenia. An intermediate degree of disturbance in subjects who had schizophrenia-related illnesses or were obligate carriers suggests that genetic factors may be important determinants of temporal lobe asymmetries in familial schizophrenia.
UNLABELLED: This study tested the hypothesis that increasing capacitance would allow a reduction in ICD size without reducing the deliverable energy. For example, the volume of a single 450 microF capacitor (390 V peak) is 1/3 less than that of two 250 microF capacitors (780 V), but it can store equivalent amounts of energy. METHODS: Endocardial defibrillation electrodes (3.4 cm) were positioned in the RV apex and at the RA/SVC junction in six mixed-breed, isoflurane anesthetized pigs (41 +/- 3 kg). Three 17-cm ribbon wires were positioned subcutaneously on the left lateral chest (SQArray). Two CPI VENTAK ECDs were equipped to deliver 60/40 biphasic waveforms using either 125 microF (STD) or 500 microF (LD) of capacitance. A 15 shock up/down protocol was used to determine the 50% probability of success levels for each waveform in each animal. Shocks were delivered from RV(-)-->SVC + SQArray(+) in random order. Results were compared using paired Student's t-tests and are reported as mean +/- SE. RESULTS: The 500 microF, long duration waveform reduced peak voltage 41% (374 +/- 18 V [STD] vs 219 +/- 14 V [LD], P < 0.001) and reduced peak current 38% (11.0 +/- 1.1 A [STD] vs 6.8 +/- 0.6 A [LD], P < 0.001) but did not significantly change the delivered energy (12.4 +/- 1.3 J [STD] vs 13.4 +/- 1.0 J [LD]). Durations increased from 10.0 +/- 0.2 to 17.6 +/- 0.5 msec (P < 0.001).(ABSTRACT TRUNCATED AT 250 WORDS)
The performance of an ICD system depends, in part, on the effectiveness with which the lead system functions. Engineering trade-offs are made during the design of a lead to optimize one or more performance characteristics: e.g., lead handling, fatigue life, size, and optimized therapy delivery. To assure low defibrillation thresholds, careful attention must be taken during the design process to prevent these trade-offs from hampering the lead's therapy effectiveness. Four basic design rules are described that capture many of the engineering concepts that will enhance a lead's efficacy: (1) minimize electrode pullback, (2) deliver current to the apex, (3) minimize energy loss in the lead, and (4) use large, efficient electrodes. These rules speak to optimizing delivery of current to the heart and efficiency of the lead and electrode interface. When the lead performs its function well, the complete ICD system of the heart, lead, and implantable pulse generator will provide optimal safety margins for device implant and an increased number of patients that can be implanted with a single-lead system.
OBJECTIVE: To assess the impact of epicardial patch electrode position on internal defibrillation efficacy. METHODS: Two mesh patch electrodes (13 cm2) were positioned on the epicardium of acute, isoflurane-anesthetized pigs (n = 7, 40-47 kg). Defibrillation efficacy was determined for three different patch positions: P1 = anterior-basal right ventricle (RV) and lateral-apical left ventricle (LV); P2 = lateral RV and lateral LV; and P3 = anterior-basal septal region and posterior-apical septal region. To quantify defibrillation efficacy, single capacitor discharge, fixed-tilt (68%) biphasic waveforms were delivered to the heart 10 seconds after initiation of ventricular fibrillation. Initial shock intensities were selected using an up/down protocol. Conversion data were used to construct sigmoidal curves relating probability of defibrillation to energy delivered, peak voltage, and peak current in each animal. RESULTS: Mean peak voltage and current at 50% defibrillation probability were 40% higher for P2 than they were for either P1 or P3 (p < 0.05). Similarly, mean energy delivered was 75% higher for P2. In this pig model, position of epicardial patch electrodes affects defibrillation efficacy. CONCLUSION: Apical-to-basal shock vectors (P1 and P3) yielded significantly lower defibrillation shock strength requirements than did a lateral-wall-to-lateral-wall vector (P2), which was perpendicular to the intraventricular septum. These data may help explain the disparity in defibrillation thresholds observed in the human population of patients undergoing implantable cardioverter defibrillator testing with epicardial patch electrodes.
The safety and efficacy of clarithromycin was compared with those of amoxicillin-potassium calvulanate for the treatment of acute otitis media in children. In a multicenter, randomized, investigator-blinded trial, 180 patients (6 months to 12 years of age) with acute otitis media were allocated to receive either clarithromycin, 15 mg/kg in two divided doses (n = 90), or amoxicillin-clavulanate, 40 mg/kg in three divided doses (n = 90), for 10 days. Middle ear samples were obtained by tympanocentesis from 175 of 180 patients. Pathogens were isolated from 137 samples (76%). Eighty-six patients in each treatment group were considered for efficacy analysis. Clinical cure or improvement was achieved within 4 days after treatment in 80 (93%) of 86 patients receiving clarithromycin and in 82 (95%) of 86 patients receiving amoxicillin-clavulanate. Recurrence of infection was observed between 5 and 35 days after treatment in 9 (11%) of 80 patients in the clarithromycin group and in 8 (10%) of 82 patients in the amoxicillin-clavulanate group. Middle ear effusion was found with similar frequency at the end of therapy and at follow-up visits in both treatment groups. Mild gastrointestinal signs and symptoms, the most common side effects, were noted in 20% and 52% of patients in the clarithromycin group and the amoxicillin-clavulanate group, respectively (p < 0.001). We conclude that clarithromycin is a safe and effective antimicrobial agent for the treatment of acute otitis media in children.
Plasma PCR for human cytomegalovirus (CMV) DNA was compared with bronchoalveolar lavage (BAL) fluid culture as an indicator for disseminated CMV infection. Thirteen (32.5%) of 40 consecutive bone marrow transplant (BMT) recipients were BAL fluid culture positive for CMV on day 35 post-BMT, and 9 (69%) of the 13 had positive plasma PCRs between days 28 and 49. Of the 27 with negative BAL fluid cultures, 2 (7%) had positive plasma PCRs (P < 0.001). Plasma CMV DNA in BMT recipients is a useful clinical marker for serious infection.
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Cell therapy, the administration of freeze-dried or lyophilized cells derived from fetal tissue of animals, has been suggested and accepted by some parents as a treatment for Down syndrome. Such therapy regimens have been purported to ameliorate dysmorphic features and to result in improvement in IQ, motor skills, social behavior, height, language, and memory. Interest in this therapy continues despite a lack of empirical support for its use and its illegality in the United States. In this study, 190 subjects of whom 21 had received cell therapy (from sources external to this study) were studied for 18 variables in the areas of growth, motor development, cognitive development, and adaptive/social status. Comparing the cell-treated group with a control group matched for sex, age, socioeconomic status, and cardiac history showed no statistically significant differences for any of the developmental or growth variables measured. These findings fail to support continued claims of improved functioning following cell therapy in persons with Down syndrome.