Clinical Evaluation of Automatic Tachycardia Diagnosis by an Implanted Device

Reliable discrimination between sinus tachycardia (ST) and pathologic tachycardia has been a major problem for automatic implantable antitachycardia devices. In patients whose sinus response to activity is as rapid or faster than their pathologic tachycardia (rate crossover), these unsophisticated devices deliver the programmed tachycardia response to either the pathologic or sinus tachycardia. Over a one-year period, 50 Intermedics Intertach Model 262–12 antitachycardia pulse generators were implanted to evaluate the specificity of a new group of tachycardia recognition algorithms. Patients were subjected to exercise testing and noninvasive programmed stimulation to demonstrate the efficacy of this new approach. The five recognition algorithms tested were various combinations of the following criteria: high rate HR), sudden onset (SO), rate stability (RS), and sustained high rate (SHR). False positive rates (tachycardia response inappropriately triggered by ST) were as follows: HR (93%); HR + SO (3%); HR + RS (63%); HR + (RS or SHR) (87%); HR + HS + SO (8%). Pair-wise significance testing between HR only and HR + SO (p < 0.001), HR + RS (p = 0.01) and HR + SO + RS (p < 0.001), demonstrated a significant reduction in the rate of false positives through the use of the sudden onset and rate stability criteria in concert with the standard high rate criterion.     

Direct and Telemetered Lead Impedance

Objectives: We undertook this study to determine whether telemetered lead impedance measurements (LIM) can be correlated with direct LIM and to determine the stability of LIM over time when measured directly and via telemetry. Methods: Direct LIM and telemetered LIM were measured in 91 patients; 101 leads during initial implantation and 40 leads during pulse generator replacement. Differences in direct LIM measured during initial implant and pulse generator replacement (direct-direct) were compared in 41 patients (28 atrial leads and 37 ventricular leads). The stability of telemetered LIM obtained immediately postoperatively, at 1 month and 1 year, postimplantation was assessed in 50 patients (23 atrial and 49 ventricular leads). Results: In atrial leads acute direct LIM was 633.9 ± 18.4 Ω versus 575.8 ± 18.5 Ω for telemetered LIM (r = 0.58), and chronic direct LIM was 670.9 ± 49.3 Ω versus 607.0 ± 36.3 Ω for telemetered LIM (r = 0.87). In ventricular leads acute direct LIM was 747.3 ± 16.9 Ω and 684.7 ± 16.4 Ω for telemetered LIM (r = 0.69), and chronic direct LIM was 674.8 ± 29.9 Ω and 625.2 ± 28.5 Ω for telemetered LIM (r = 0.68). The mean direct–direct UM rose 124 Ω (P < 0.001) in atrial leads and 10 Ω (P = NS) in ventricular leads. Telemetered LIM for atrial leads was 581.0 ± 27.6 Ω immediately postimplantation compared to 625.7 ± 34.8 Ω at 1 month and 754.1 ± 43.0 Ω at 1 year. Telemetered LIM for ventricular leads was 661.3 ± 17.5 Ω at implant, 684.6 ± 20.7 Ω at 1 month and 724.7 ± 22.7 Ω at 1 year. Conclusions: There is a good but limited correlation between direct and telemetered LIM. Mean direct LIM obtained at initial implantation is similar to that measured at pulse generator replacement. The telemetered LIM is stable over the first month postimplantation but tends to rise during the first year of follow-up and substantial changes in impedance are not uncommon in individuals with normal function. There is a tendency for LIM to rise with lead maturation. If telemetered LIM is to be followed over time, a baseline telemetered value should be obtained immediately postoperatively.     

Chronic Morpholine Exposure of Rats

Chronic Morpholine Exposure of Rats. HARBISON, R. D., MARINO,D. J., CONAWAY, C. C., RUBIN, L. F., AND GANDY, J. (1989). FundamAppl. Toxicol. 12,491–507. The chronic toxicity and carcinogenicpotential of morpholine were evaluated in 60 Sprague-Dawleyrats/sex/group receiving morpholine at mean inhalation exposureconcentrations of 0, 10, 50 and 150 ppm for 6 hr/day, 5 days/week,for 104 weeks. Survival, body weight gains, organ weights, hematology,and clinical chemistries were normal in exposed groups and comparableto those of the control animals. The incidences of palpabletissue masses and of histologically confirmed neoplasia werecomparable among all groups, including the control groups, andwere typical of the strain and age of the rats tested. In-lifeclinical examinations revealed increased incidences of irritationaround the eyes and nares, chromadacryorrhea, and urine stainson the fur, predominately in high-dose animals. Morpholine exposurewas associated with corneal irritation seen by ophthalmoscopicexamination and confirmed microscopically as keratitis limitedto the highest exposure group. Irritation of the maxillary andnasoturbinates as indicated by infiltration of neutrophils,focal squamous metaplasia of the turbinate epithelium, and necrosisof the turbinate bone was observed in high-dose animals. Therefore,chronic exposure of rats to morpholine for 2 years at concentrationsof 150 ppm or less revealed no carcinogenic potential or chronicsystemic toxicity. Consistent with its known irritating properties,morpholine produced only local irritation, which was limitedalmost exclusively to high-dose animals.     

Mouse Liver Carcinogenesis: Mechanisms and Relevance

Symposium Overview: Mouse Liver Carcinogenesis: Mechanisms andRelevance. GOODMAN, J. I., WARD, J. M., POPP, J. A., KALUNIG,J. E., AND FOX, T. R. (1991). Fundam. Appl. Toxicol. 17, 651–665.     

The Application of Non-Default Uncertainty Factors in the U.S. EPA's Integrated Risk Information System (IRIS). Part I: UF L,UF S,and “Other Uncertainty Factors”

The United States Environmental Protection Agency's Integrated Risk Information System (IRIS) includes hazard identification and dose-response assessment values developed by Agency scientists. Uncertainty factors (UFs) are used in the development of IRIS values to address the lack of information in five main areas. The standard UFs account for interspecies uncertainty (UF_A) and intraspecies variability (UF_H). The UF_A addresses uncertainty related to the extrapolation of data from animals to humans, whereas the UF_H addresses variability amongst individuals (i.e., intrahuman). Additional UFs have been employed to account for database incompleteness, extrapolations from a lowest-observed-adverse-effect level in the absence of a no-observed-adverse-effect level (UF_L), and subchronic-to-chronic extrapolation (UF_S). A sixth UF designated as “other uncertainty factors” (UF_O) has also been applied in place of the UF_L to account for uncertainty with the adversity of points of departure obtained using benchmark dose modeling. This review will discuss how UF_L, UF_S, and UF_O have been applied in IRIS assessments, along with the rationale used to describe the choice of UF values that deviate from the standard default of 10.     

Utility and Safety of Axillo‐subclavian Venous Imaging with Carbon Dioxide (CO2) Prior to Chronic Lead System Revisions

Background: Prior to attempting placement of one or more electrodes to revise existing rhythm control devices, patency of the central veins should be documented, in view of a high incidence of significant chronic occlusions. Since iodinated contrast venography may be contraindicated in select situations, imaging of the axillo‐subclavian venous system with gaseous carbon dioxide (CO₂) was evaluated prospectively in 23 consecutive individuals who were considered for revision of previously implanted pacemaker or automatic cardioverter defibrillator lead systems. Methods: Approximately 20 mL of CO₂ were manually infused via CO₂ primed injection tubing into a vein at or above the level of the antecubital fossa ipsilateral to the side of prior lead placements. Digital subtraction imaging over the axillo‐subclavian region, lower neck, and mediastinum was performed. Formal interpretation was obtained from one of three interventional radiologists and at least one electrophysiologist. Results: Significant venous occlusions were identified in five (22%) patients. Vascular access utilized for the subsequent 18 revisions performed included the imaged patent ipsilateral vein in 14 patients and the contralateral, right‐sided subclavian venous system in three patients. One patient required epicardial left ventricular lead placement. There were no complications from venography. Conclusions: Axillo‐subclavian venography with gaseous CO₂ in patients undergoing pacemaker or implantable cardioverter defibrillator lead revisions is feasible and safe when use of iodinated dye is contraindicated. This technique should be employed in patients with azotemia, dye contrast allergies, or significant inflammation in the vicinity of the intravenous line insertion. (PACE 2010; 790–794)     

The Atrial Electrogram During Clinical Electrophysiologic Studies: Onset versus the Local/Intrinsic Deflection

The Local Atrial Deflection. Introduction : As a wave front passes unfiltered bipolar recording electrodes, the point of local depolarization is marked by a maximal change in voltage, i.e., the intrinsic deflection. However, during electrophysiologic studies, the depolarization (A) on the lead recording the His-bundle potential traditionally has been measured at the first rapid reproducible deflection on a filtered electrogram. This methodology permits considerable latitude for subjective interpretation. The purpose of this study was to assess the timing of the atrial electrogram using the intrinsic deflection of relatively unfiltered electrograms (0.1-4.0 to 1,250 Hz) or the equivalent on filtered recordings. Methods and Results : To do this we studied 70 patients without evidence of atrial or atrioventricular (AV) nodal disease, documenting the difference in timing between the A wave as traditionally measured and as measured at its peak local deflection (A_L) determined from simultaneously recorded filtered and relatively unfiltered electrograms. New ranges based on the A_L were established for timing of intra-atrial and AV nodal conduction intervals. The P-A (41 ± 11 msec) was significantly shorter than the P-A_L (55 ± 12) and the A-H (80 ± 20) was longer than the A_L-H (66 ± 21 msec), both P <0.001. Interobserver differences in measurements were smaller when using the local (A_L) rather than traditional criteria. Conclusions : Conventional measurement of the A deflection provides only a rough estimate of local depolarization of the atrium near the AV node. The criteria proposed in the present article may (1) provide a better estimate of the timing of local depolarization; (2) have application in computerized timing of intervals; and (3) decrease technical problems and subjective error.     

Just How Stable Are Escape Rhythms after Atrioventricular Junction Ablation?

Background: Atrioventricular (AV) node ablation with implantation of a permanent pacemaker is an established mode of therapy in the treatment of atrial fibrillation. However, concern exists regarding subsequent dependency on an entirely paced rhythm and the possible sequela of unheralded pacemaker failure. Data regarding escape rhythm lability, an important feature of pacemaker dependency, are limited. Aims and Methods: The purpose of this study was twofold: (1) to determine the characteristics of escape rhythms at predefined serial time intervals following AV node ablation and pacemaker implantation, and (2) to identify risk factors predictive of unstable escape rhythms. Patients undergoing AV node ablation and pacemaker implantation were assessed for the presence or absence of an escape rhythm during pacemaker interrogation at five predetermined serial time points. Baseline demographics and comorbid conditions were evaluated as potential predictors of those with labile escape rhythms. Results : Seventy‐nine percent of the 96 patients studied had an underlying escape rhythm (≥30 beats per minute) immediately postablation. Although the percentage of patients with an escape rhythm increased at each follow‐up interval, the number of patients who consistently demonstrated an escape rhythm declined with each follow‐up, with 28% of patients lacking an escape rhythm at some time point, i.e., labile escape rhythm. There were no significant predictors of a labile escape rhythm. Conclusion: Among patients who have undergone AV node ablation and pacemaker implantation, 72% have a stable escape rhythm over time, but others are at risk for pacemaker dependency, as predicted by an underlying absent or labile escape rhythm. (PACE 2010; 939–944)     

The Psychological Impact of Implantable Cardioverter-Defibrillator Recalls and the Durable Positive Effects of Counseling

Background: It is known that patients with lifesaving devices such as implantable cardioverter-defibrillators (ICDs) may be alarmed and worried by recalls or alerts related to their ICDs.
Objectives: This study aimed to determine whether counseling has any short- or long-term benefits, and to look for characteristics that identify those most worried and those most in need of counseling.
Methods: Among 100 patients with recall or alert ICDs, 14 were pacer dependent; 50 had ICDs for 1° prevention and 22 were women. Patients completed a survey indicating how worried they were on learning of the recall or alert (0–10 scale). After counseling and advice in accordance with manufacturer guidelines, patients were asked to indicate their level of worry, and were again asked after 6 months.
Results: For all patients, the "worry level" at the initial interview was 5.0 ± 3.7, falling to 2.2 ± 3.0 after counseling (P < 0.001) and 1.4 ± 2.3 after 6 months (P < 0.001 vs both earlier levels). There were no significant differences between those implanted for 1° versus 2° prevention or for pacer dependency. Women were initially more worried than men, but not for the long term. The 49 patients whose ICDs could be managed by reprogramming or software fix had significant reduction in worry after counseling and at 6 months compared to others. The 18 patients recommended for operative intervention remained more concerned after counseling (3.5 ± 3.3 vs 1.9 ± 2.9, P = 0.043).
Conclusions: Patients' concerns resulting from ICD recalls or alerts can be reduced by appropriate counseling. Those patients whose ICDs could be reprogrammed to safer parameters had the most reduction in worry levels.