Joseph Fetter

CLINICAL EXPERIENCE WITH THERA DR RATE-DROP RESPONSE PACING ALGORITHM IN CAROTID SINUS SYNDROME AND VASOVAGAL SYNCOPE

This study examined the effectiveness of cardiac pacing using the Thera DR rate‐drop response algorithm for prevention of recurrent symptoms in patients with carotid sinus syndrome (CSS) or vasovagal syncope. The algorithm comprises both diagnostic and treatment elements. The diagnostic element consists of a programmable “window” used to identify heart rate changes compatible with an evolving neurally mediated syncopal episode. The treatment arm consists of pacing at a selectable rate and for a programmable duration. Forty‐three patients (mean age 53 ± 20.4 years) with CSS alone (n = 8), CSS in conjunction with vasovagal syncope (n = 4), or vasovagal syncope alone (n = 31) were included. Thirty‐nine had recurrent syncope, while the remaining four reported multiple presyncopal events. Prior to pacing, 40 ± 152 syncopal episodes (range from 1 to approximately 1,000 syncopal events) over the preceding 56 ± 84.5 months. Postpacing follow‐up duration was 204 ± 172 days. Three patients have been lost to follow‐up and in one patient the algorithm was disabled. Among the remaining 39 individuals, 31 (80%) indicated absence or diminished frequency of symptoms, or less severe symptoms. Twenty‐three patients (23/29, or 59%) were asymptomatic with respect to syncope or presyncope. Sixteen patients had symptom recurrences. Of these, seven experienced syncope (7/39, or 18%) and 9 (29%) had presyncope: the majority of patients with recurrences (6/7 syncope and 7/9 presyncope) were individuals with a history of vasovagal syncope. Consequently, although symptoms were observed during postpacing follow‐up, they appeared to be of reduced frequency and severity. Thus, our findings suggest that a transient period of high rate pacing triggered by the Thera DR rate‐drop response algorithm was beneficial in a large proportion of highly symptomatic patients with CSS or vasovagal syncope.

The effects of nuclear magnetic resonance imagers on external and implantable pulse generators.

This study evaluates the effect of nuclear magnetic resonance (NMR) scanning on pacemaker function. it must be emphasized that each manufacturers pulse generators and each pacing modality may behave differently and, therefore, require individual evaluation. According to our results, patients with pacemakers should have their pacing activity monitored continuously during scanning with the NMR 1500 gauss imaging system. External pulse generators should he net to the asynchronous mode and placed outside the NMR image volume but within the radiofrequency [RF] shield. Implanted pacemakers should be verified for type and mode of operation. Ail implantable pulse generators evaluated reverted from the demand to the asynchronous mode within the magnetic field of the scanner. There was no observable damage to the discrete pacemaker components that were tested.

Digital Cellular Telephone Interaction With Implantable Cardioverter-Defibrillators

OBJECTIVES This study sought to determine, in vivo, whether electromagnetic interference (EMI), generated by North American Digital Communications (NADC)/Time Division Multiple Access-50-Hz (TDMA-50) mobile cellular digital telephone model AT&T 6650, disturbs normal implantable cardioverter-defibrillator (ICD) operation and to verify these observations in vitro by testing a selection of telephones representing worldwide systems. METHODS The effects of cellular phone interference on the operation of various models of market-released ICDs from a single manufacturer, Medtronic, Inc., were tested. The in vivo clinical test was undertaken in 41 patients using the AT&T 6650 digital telephone with the NADC/TDMA-50 technology. The in vitro component of the study was examined twofold: 1) antenna generated far field; and 2) analog/digital cellular telephone near field. RESULTS None of the ICDs tested in 41 patients were affected by oversensing of the EMI field of the cellular telephones during the in vivo study. Therefore, the binomial upper 95% confidence limit for the failure rate of 0% is 7%. The in vitro antenna-generated field testing showed that telephone modulation frequencies used in the international Global System Mobile and TDMA-50 cellular telephone technologies did not result in ICD sensing interference at the predicted electric field intensity. The in vitro near field tests were performed using both analog and digital cellular telephones in service, or in the test mode, and indicated no interaction with normal operation. However, the static magnetic field generated by the cellular telephone placed over the ICD at a distance < or = 0.5 cm will activate the internal reed switch, resulting in temporary suspension of ventricular tachycardia and fibrillation detection. CONCLUSIONS We conclude that TDMA-50 cellular telephones did not interfere with these types of ICDs. However, we recommend that the patient not carry or place the digital cellular telephone within 15 cm (6 in.) of the ICD.

Intracavitary electrode catheter cardioversion of atrial tachyarrhythmias in the dog

This study examined factors determining efficacy of intracavitary cardioversion of atrial tachyarrhythmias in closed chest, anesthetized dogs with talc pericarditis. Electrode catheters were positioned transvenously with the cathode in the right atrial appendage. In Group 1 dogs (n = 6), three anode sites (superior and inferior venae cavae ostia and mid-right atrium) were tested with graded energy shocks to determine the lowest effective cardioversion energy at each anode position. In Group 2 dogs (n = 9), multiple cardioversion attempts with energy levels of 0.01 to 5.0 J were used to evaluate reproducibility of energy thresholds. In Group 3 dogs (n = 6) without talc-induced pericarditis, atrial pathologic study was done after five intracavitary shocks (0.5 or 5.0 J). In Group 1, cardioversion was achieved with 0.75 J or less with no significant difference in minimal effective cardioversion energies among the three anode positions tested. In Group 2, 98 (26%) of 372 cardioversion attempts were successful. Intra-animal minimal effective cardioversion energies varied widely, and timing of shocks relative to atrial electrograms did not influence efficacy. Complications were infrequent and included delayed sinus rhythm recovery, transient atrioventricular block and ventricular fibrillation. Ventricular fibrillation occurred in 9 (2.4%) of 372 shocks, and was associated with higher delivered energies (6 of 9 with greater than or equal to 1.0 J) and with shocks delivered 116 to 180 ms after onset of the QRS complex. In Group 3, two dogs had no histologic damage, three dogs had multiple small foci of subendocardial necrosis and in one dog these foci coalesced to involve half the atrial wall thickness. Thus, low energy cardioversion of atrial tachyarrhythmias is feasible using intracavitary electrodes. Synchronization of energy delivery to the QRS complex is important to minimize risk of ventricular fibrillation.

Electromagnetic interference from welding and motors on implantable cardioverter-defibrillators as tested in the electrically hostile work site

OBJECTIVES This study was designed to determine the susceptibility of an implanted cardioverter-defibrillator to electromagnetic interference in an electrically hostile work site environment, with the ultimate goal of allowing the patient to return to work. BACKGROUND Normal operation of an implanted cardioverter-defibrillator depends on reliable sensing of the hearts electrical activity. Consequently, there is concern that external electromagnetic interference from external sources in the work place, especially welding equipment or motor-generator systems, may be sensed and produce inappropriate shocks or abnormal reed switch operation, temporarily suspending detection of ventricular tachycardia or ventricular fibrillation. METHODS The effects of electromagnetic interference on the operation of one type of implantable cardioverter-defibrillator (Medtronic models 7217 and 7219) was measured by using internal event counter monitoring in 10 patients operating arc welders at up to 900 A or working near 200-hp motors and 1 patient close to a locomotive starter drawing up to 400 A. RESULTS The electromagnetic interference produced two sources of potential interference on the sensing circuit or reed switch operation, respectively: 1) electrical fields with measured frequencies up to 50 MHz produced by the high currents during welding electrode activation, and 2) magnetic fields produced by the current in the welding electrode and cable. The defibrillator sensitivity was programmed to the highest (most sensitive) value: 0.15 mV (model 7219) or 0.3 mV (model 7217). The ventricular tachycardia and ventricular fibrillation therapies were temporarily turned off but the detection circuits left on. CONCLUSIONS None of the implanted defibrillators tested were affected by oversensing of the electric field as verified by telemetry from the detection circuits. The magnetic field from 225-A welding current produced a flux density of 1.2 G; this density was not adequate to close the reed switch, which requires approximately 10 G. Our testing at the work site revealed no electrical interference with this type of defibrillator. Patients were allowed to return to work. The following precautions should be observed by the patient: 1) maintain a minimal distance of 2 ft (61 cm) from the welding arc and cables or large motors, 2) do not exceed tested currents with the welding equipment, 3) wear insulated gloves while operating electrical equipment, 4) verify that electrical equipment is properly grounded, and 5) stop welding and leave the work area immediately if a therapy is delivered or a feeling of lightheadedness is experienced.

The Clinical Incidence and Significance of Myopotential Sensing with Unipolar Pacemakers

Myopotential oversensing by unipolar pulse generators can cause patient symptoms ranging from dizziness and syncope to ventricular tachycardia. Seventy‐seven patients with implanted unipolar pacemakers from three manufacturers participated in isometric and reach exercises to evaluate their pacemakers susceptibility to myopotentials. Myopotential inhibition occurred in 47% of the patients performing the reach maneuver. Testing revealed a wide difference in level of susceptibility to myopotentials between pacemakers of different manufacture (a low of 33% inhibition for the least susceptible to a high of 78% inhibition for the most susceptible during the reach maneuver). The normal pacing interval was extended by myopotential oversensing for each manufacturers model within a range of 0.3–3.9 seconds. Pulse generators incorporating additional automatically‐adjusting threshold and reversion circuits in the sense amplifier along with standard bandpass filtering exhibited: a) two‐to‐three times less susceptibility to myopotentials; and b) a 75% reduction in the maximum pacing interval extension as compared with pacemakers with bandpass filtering alone. The effectiveness of insulative coating in reducing myopotential inhibition was substantiated as coated pulse generators had a 22% lower incidence of muscle sensing than those than were uncoated. Six out of seven patients tested had symptoms during Holter monitoring which correlated with pacemaker myopotential inhibition. Selecting pulse generators with improved sensing amplifiers, clinical testing of patients with unipolar pacemakers using the reach method, and reprogramming of sensitivity will significantly reduce the incidence of myopotential inhibition.

The safety and efficacy of chronic ventricular pacing at 1.6 volts using a steroid eluting lead.

Steroid eluting leads may allow for lower chronic pacing thresholds and therefore lower pacing outputs. Twenty‐two patients (15 presenting with syncope) were implanted with VVI or VVIR pacemakers and transvenous steroid eluting leads and followed for a mean of 20.6 months while being paced at 1.6 V and 0.6 msec. Mean acute voltage pacing thresholds were 0.40 V at 0.5 msec and chronic pulse width thresholds were 0.22 msec at 0.8 V. Pacemaker function was documented with one to three 24‐hour Holter monitors, attached during the 2–6 week postimplant period, bimonthly transtelephonic monitoring, and monthly pacemaker clinic visits. No patient developed recurrent symptoms and consistent capture ivas verified in all patients on every 24‐hour Holter recording and transtelephonic monitor. Chronic ventricular pacing at an output of 1.6 V at 0.6 msec is safe and effective when using a steroid eluting lead and potentially has implications for pacemaker longevity.

Rate-Drop Response Cardiac Pacing for Vasovagal Syncope

Recent reports suggest that cardiac pacing incorporating a rate-drop response algorithm is associated with a reduction in the frequency of syncopal episodes in patients with apparent cardioinhibitory vasovagal syncope. The detection portion of the algorithm employs a programmable heart rate change-time duration “window” to both identify abrupt cardiac slowing suggestive of an imminent vasovagal event and trigger “high rate” pacing. The purpose of this study was to develop recommendations for programming the rate-drop response algorithm. Pacemaker programming, symptom status, and drug therapy were assessed retrospectively in 24 patients with recurrent vasovagal syncope of sufficient severity to warrant consideration of pacemaker treatment. In the 53±19 months prior to pacing, patients had experienced an approximate syncope burden of 1.2 events/month. During follow-up of 192±160 days, syncope recurred in 4 patients (approximate syncope burden, 0.3 events / month, p < 0.05 vs. pre-pacing), and pre-syncope in 5 patients. In these patients, rate-drop response parameters were initially set based on electrocardiographic and/or tilt-table recordings, and were re-programmed at least once in 14 (58%) individuals. A 20 beat/min window height (top rate minus bottom rate), a window width of 10 beats (61% of patients), and 2 or 3 confirmation beats (79% of patients) appeared to be appropriate in most patients. Treatment intervention rate was set to >100 beats/min 89% of patients, with a duration of 1 to 2 min in 79%. In conclusion, a narrow range of rate-drop response parameter settings appeared to be effective for most individuals in this group of highly symptomatic patients.

Effects of Extracorporeal Shock Wave Lithotripsy on Single Chamber Rate Response and Dual Chamber Pacemakers

This study evaluated effects of extracorporeal shock wave lithotripsy on four models of Medtronic implantable cardiac pacemakers. In vitro testing consisted of: (1) unsynchronized pacemaker strapped on the patient with extracorporeal shock synchronized to the patients native heart rate; and (2) pacemakers suspended alone in water 6 inches from the focal point, synchronizing the extracorporeal shock to pacemaker output. Unsynchronized shocks affected each model of pacemaker diferently, i.e., single chamber constant rate pacemakers experienced extended periods of inhibition for more than three pacing cycles while activity‐triggered rate response pacemakers exhibited rate increases to the upper rate setting. Dual chamber synchronous pacemakers exhibited intermittently a 59% decrease and a 20% increase in ventricular rate due to inhibition and triggering, respectively, from shock over‐sensing. Synchronized shocks did not alter the rate of single chamber constant rate pacemakers, but did cause the rate to increase to the upper rate setting for activity‐triggered rate response pacemakers. The shock was synchronized to the initial atrial output from the dual chamber pacemaker and caused frequent inhibition of the ventricular stimulus when the ventricular‐safety‐pace (VSP) feature was programmed off. Programming VSP on reduced the incidence of ventricular inhibition resulting in near normal pacemaker operation. There was neither observable damage to pacemaker components nor spurious reprogramming of pacemaker parameters during the tests. Our studies with one manufacturers pacemakers suggests that lithotripsy shock effects on implantable pacemakers can be tolerated provided: (1) the single chamber pacemaker is programmed to the demand constant rate modality; (2) the dual chamber pacemaker is programmed to VSP on or to the VVI mode; and (3) the pacemaker distance to the focal point is > 6 inches. ECG monitoring is standard practice during the procedure and should be adhered to as an optional measure to verify normal intrinsic rhythms or pacemaker operation.

Transtelephonic Monitoring and Transmission of Stored Arrhythmia Detection and Therapy Data From an Implantable Cardioverter Defibrillator

A new transtelephonic monitoring device designed for use with implantable Cardioverter defibrillators (ICDs) was evaluated. It is capable of interrogating ICDs and transmitting the following data via telephone: programmed parameters (e.g., ventricular tachycardia [VT] and ventricular fibrillation [VF] detection, therapies), number of VT and VF episodes, identification of successful therapies, the 20 cycle lengths preceding the last episode detected, the 10 cycle lengths after the last delivered therapy, battery voltage, and real‐time transmission of the patients rhythm. Eighteen patients (mean age 64 ± 17years; 15 males) were implanted with an ICD and epicardial lead system. The patients who did not live near the primary hospital were provided with this transmitter and instructed to transmit monthly and whenever presyncope, syncope, or a shock were experienced. Five hundred ten episodes of spontaneous arrhythmia (495 VT, 15 VF) were detected in 14 of 18 patients in a 24‐month period and the success of each therapy (antitachycardia pacing, cardioversion 0.4‐34 J, defibrillation 34 J) was analyzed. The number of therapies delivered and their success (%) in terminating the arrhythmia were: 380 ramp/86%, 116 burst/84%, 119 cardioversion/57%, and 15 defibrillations/ 100%. Sixty‐three (42%) of the 152 transmissions indicated an arrhythmia. Twenty‐five (16%) of the 152 were transmitted because of symptoms. Sixteen (9.7%) of 165 VT episodes could not be terminated by the full set of programmed VT therapies. Analysis of the pre‐ and post‐episode intervals along with the patients transmitted rhythm indicated that sinus tachycardia or atrial fibrillation were likely responsible for these episodes. The transmitted data included the real‐time ECG, which provided acute rhythm status plus stored data from the ICDs memory identifying the chronic arrhythmias detected, the therapies delivered, and the number and type of successful and ineffective therapies. This information provided the clinical data to the primary physician in order to determine the effectiveness of the programmed detection and therapy parameters and in some cases recommend to the home physician modifications to the device parameters or medication adjustments for enhanced arrhythmia control. We conclude that telephone transmission of stored ICD data is feasible and useful for patient management. It may obviate the need for patients experiencing symptoms to return to a site capable of device interrogation.