[Evidence-based medicine. Indications for cardiac pacemakers]. / Evidence-based medicine. Les indications de stimulateurs cardiaques.

Recently published international recommendations classify indications for permanent cardiac pacing according to their level of evidence of clinical benefit. Sick sinus syndrome, AV conduction disturbances, carotid sinus hypersensitivity and congestive heart failure are successively discussed. Good quality practice not only includes careful indication analysis but also a rational choice of pacemaker type. In sick sinus syndrome, the clinical interest of physiological pacing modes clearly appears, particularly in the prevention of atrial fibrillation.

Heart graft monitoring by the ventricular evoked response.

Monitoring of the negative slew rate of the evoked T wave has been proposed as a noninvasive diagnostic tool to follow heart transplant recipients. The clinical contribution of this measurement on telemetrically recorded, paced unipolar ventricular electrograms was evaluated in the detection of grade 3 acute allograft rejection. Thirteen patients undergoing heart transplantation received a DDD pacemaker connected to two epimyocardial leads. Electrograms were recorded and digitized after each endomyocardial biopsy (EMB). The maximum slew rate of the descending slope of the repolarization phase (RSP) was extracted and normalized. A 20% downward shift of RSP from the reference value was considered abnormal. Results of signal processing were blinded during the first 6 months. Eleven patients completed the 6 months blinded period and two patients died. A total of 101 EMB were graded according to the International Society for Heart and Lung Transplantation classification. Grade 3 was assigned to 9 EMB. A significant difference was found between RSP values measured during grade 3 rejection episodes and other RSP values (P < 0.001). A diagnostic model consisting of a single threshold test confirmed the ability of RSP to predict significant signs of rejection on EMB (P < 0.0001). The sensitivity of RSP in detecting grade 3 rejections was 100%, specificity was 81%, negative predictive value 100%, and positive predictive value 35%. The use of RSP as a noninvasive monitoring tool to pose the indication for a biopsy would avoid 73% of EMB. Monitoring of transplanted hearts based on the analysis of the ventricular evoked response is promising and may markedly reduce the number of EMB.

[Cardiac pacemakers and cellular phones]. / Stimulateurs cardiaques et GSM.

Digital cellular phones pose a potential risk of temporary pacemaker dysfunction. However, this risk could be dramatically reduced using simple patients recommendations and careful programming of sensing parameters.

Atrial flutter: historical background.

For five decades, the mechanism of atrial flutter remained controversial, with protagonists and antagonists of circus movement versus ectopic focus theories. The development of clinical electrophysiology in the 1970s and the observations made by many authors in various canine heart models supported the concept of atrial flutter as a reentrant wave confined to the right atrium. It was established that, in the common type of atrial flutter, the activation wavefront proceeds in a cranial direction over the right atrial septum and descends on the right atrial free wall in the caudal direction. A zone of slow conduction was identified inferiorly and posteriorly in the right atrium, target of the modern ablative techniques. The history of atrial flutter clearly illustrates the bidirectional flow of information and the mutual stimulation between the basic and the clinical levels, leading both to a better understanding of the nature of the arrhythmia and to new therapeutic approaches.

Stepwise analysis of the calibration procedure of an accelerometer-based pacemaker.

UNLABELLED: The rate modulation of Relay 294-03 is individually adjusted during a 3-minute calibration test corresponding to the collection of moderate acceleration signals (MAL), which are related to a programmable moderate pacing rate (PR). Those rate/acceleration values form a calibration point in the flat part of the rate response curve (RRC). To help in a more clinically oriented analysis of this feature, the stimulator was first calibrated while strapped on a volunteer who remained seated (low MAL), walked (medium MAL), or jogged (high MAL). The device was then mechanically submitted to three calibrated to and fro movements corresponding to the sensitivity spectrum of the sensor. Each movement was repeated ten times to test the influence of the slope (1-10). RESULTS: (1) One-way ANOVA significant effect of the MAL recorded during the calibration test on subsequent rate modulation (P = 0.0001); (2) The sensor amplifier gain was inversely related to the MAL: high MAL induced lower amplifier gain and lower PR for identical accelerations; (3) Lower amplifier gain allowed to discriminate highest acceleration magnitudes before reaching an overflow of the sensor; (4) The maximum achievable PR increased not only with the programmed slope, but also with decreasing MAL (P = 0.0055): a low MAL shifts to the left calibration point located on the part of the RRC and makes the last steep part of the RRC start earlier, thus leading to higher maximum achievable PR. In conclusion the calibration procedure is crucial not only in defining a moderate acceleration intensity but also in determining the sensor amplifier gain and the maximum achievable PR.

Usefulness and adequacy of sensor data storage and retrieval for rate response simulation.

The usefulness of sensor data storage for rate response simulation was evaluated using a new dual chamber rate modulated pacemaker sensitive to acceleration forces (Relay 294-03 [Intermedics Inc.]). The pacemaker can store the sensor output during routine exercise and those values can be used to simulate rate profiles for other rate response settings. The predictive value of this feature was evaluated in three studies (mechanical, external pacemaker, and implanted pacemaker). In the first study, the pacemaker was submitted to three runs of eight different mechanical calibrated to-and-fro movements. In the second study, nine external pacemakers were strapped on healthy volunteers who performed three jogging tests. Finally, the predictive value of the simulation was studied in five implanted patients during three successive walking tests. In each study, the pacemaker was submitted three times to the same activity. The responsiveness was successively set to 5, 1, and 10, and the pacemaker outputs were continuously recorded on a Holter monitor. At the end of the first run, rate profile simulations for slopes 1 and 10 were performed; slope 5 rate response was simulated after the second run. A regression analysis was used to establish the correlation between predicted and achieved pacing rates for each study. The coefficients of correlation between predicted and measured pacing rates for the mechanical, external, and clinical studies were 0.999, 0.985, and 0.823, respectively. The corresponding slopes of regression lines were 1.005, 0.971, and 0.935. Calculated rate profile has a high predictive value and could be used to optimize rate responsive settings without serial exercise testings.

Clinical interest of a sensor driven algorithm limiting ventricular pacing rate during supraventricular tachycardia in dual chamber pacing.

UNLABELLED: A sensor driven algorithm limiting ventricular pacing rate during supraventricular tachycardia (SVT) is included in a dual chamber rate modulated pacemaker sensitive to acceleration forces (Relay, 294-03, Intermedics Inc.). According to the intensity of concomitant exercise, the ventricular pacing rate is limited either to the programmed maximum pacing rate (MPR) or to an interim lower limit, called "conditional ventricular tracking limit" (CVTL). The MPR prevails over the CVTL when the sensor calculated pacing rate exceeds the minimal rate by more than 20 beats/min. The purpose of the study is to determine the clinical safety and efficacy of this algorithm in patients with intermittent SVT. METHOD: A Relay was implanted in four patients with a bradycardia/tachycardia syndrome and in four patients with complete atrioventricular block (CAVB). All had episodes of paroxysmal atrial tachycardia. The units were programmed in DDDR: rate responsive parameters were adjusted by simulating the rate response during three levels of exercise to let the MPR override the CVTL only during strenuous exercise. Holter monitors and exercise testings were performed at 3-month follow-up. RESULTS: In seven patients, Holter recordings showed supraventricular arrhythmias at rest with a ventricular pacing rate limited to the CVTL. Appropriate rate increases during exercise testings were also demonstrated. Three devices had to be reprogrammed in DDIR (one patient suffering from nearly permanent atrial flutter and two patients not tolerating the CVTL pacing rate at rest). CONCLUSION: The CVTL algorithm is effective in protecting against high ventricular pacing rates during supraventricular arrhythmias. It allows the selection of the DDDR mode even with a high MPR in patients with intermittent SVT.

In vitro evaluation of a sensor sensitive to acceleration forces included in a new rate modulated pacemaker.

UNLABELLED: The characteristics of the sensor and rate adaptive algorithm included in a new dual chamber rate responsive pacemaker (Relay 294-03, Intermedics, Inc.) were studied by submitting the device to calibrated to-and-fro movements of specific frequencies and peak accelerations by means of a mechanical arm connected to a speed adapter. Atrial pacing rate was continuously recorded on a Holter monitor. The influences of the frequency, the magnitude, and the axis of the acceleration forces as well as the reproducibility of the rate response were evaluated. RESULTS: (1) The sensor was sensitive to frequencies ranging from 0.5 to 7 Hz with a peak sensitivity at 3 Hz; (2) the pacing rate was not affected during movements at frequencies > 6 Hz, commonly presented as nonactivity related signals (car, bus transportation, drilling....); (3) the pacing rate increased as a function of the acceleration magnitude up to 0.5 G (0.3 G for 3 Hz), then remained constant. This level of acceleration usually corresponds to high degrees of activity; (4) rate response was maximum when acceleration was directed in the anteroposterior direction; (5) reproducibility of the rate response was excellent (R2: 0.999; slope of the regression line: 0.999). CONCLUSION: Relay 294-03 is a low frequency signal sensing rate modulated pacemaker using an accelerometer sensitive to motion, mainly in the anteroposterior direction.

Clinical experience with a new activity sensing rate modulated pacemaker using autoprogrammability.

Sensolog 703 is a new single chamber activity sensing rate modulated pacemaker that offers an automatic adjustment of settings called Autoset. Units were implanted in 11 patients (mean age: 67 years) for atrioventricular block (two patients), sinoatrial block (three patients), sick sinus syndrome (four patients), chronotropic incompetence (one patient), and atrial fibrillation with slow ventricular response (one patient). The devices were programmed in VVIR mode using Autoset. The accuracy of the settings was verified by the built-in histogram function. In 6/11 patients, these settings were not satisfactory. Autoset was repeated at 6 months (nine patients) and 10 months (five patients) after implantation. External telemetric recordings during daily life activities, Holter monitoring, bicycle or treadmill stress tests helped in the evaluation of the rate response obtained with the automatic programming. The following problems were encountered: maximum pacing rate for a low level of exercise (four patients), insufficient rate increase (four patients), higher pacing rate during low than during heavy exercises (four patients). A time-consuming (15 to 48 minutes) manual programming was necessary in eight out of nine patients (6 months) and five out of five patients (10 months). In our study, Sensolog 703 algorithm tended to behave as an on/off system; automatic programming was time consuming and only indicative.