New Integrated Sensor Pacemaker: Comparison of Rate Responses Between an Integrated Minute Ventilation and Activity Sensor and Single Sensor Modes During Exercise and Daily Activities and Nonphysiological Interference

A dual sensor DDDR pacemaker (DX2 Model 7970, Medtronic Inc.) has integrated the rate response of minute ventilation (MV) and activity (ACT) sensors. False rate acceleration by the ACT (constrained upper rate) and MV (cross-checked by ACT) is reduced. We examined the rate response profile and rate kinetics of the automatically optimized integrated sensor by comparing with the projected rate response of ACT and MV sensors alone in nine patients. After 1 month of sensor optimization using rate profile optimization (RPO), patients underwent maximal and submaximal treadmill exercises and performed activities of daily living (ADL). The integrated sensor mode gave a faster speed of rate response with a shorter delay time, time to 50% rate response and time to 90% of rate response compared to the MV sensor during hall walk (0.37 ± 0.08, 0.7 ± 0.09, 1.43 ± 0.19 vs 1.11 ± 0.1, 1.75 ± 0.14, 2.91 ± 0.17 min; P < 0.05), The average maximal sensor rates were significantly more proportional for the integrated sensor mode compared with either the ACT or MV mode. There was no significant difference in both the maximal pacing rate among the three sensor modes during maximal exercise and the rate decay during recovery. During interference studies by arm swinging (30–40 swings/min) and external tapping of the pacemakers (2 taps/s), there was only a moderate increase in pacing rate by 13 ± 9, 16 ± 5 beats/min. Hence, the new integrated sensor with the automatic rate profile optimization algorithm resulted in improved rate response profiles during submaximal exercise and ADL compared to the individual sensor response, and the sensor blending and cross-checking algorithm made the pacemaker relatively immune to false triggering of both the ACT and MV sensors.     

Atrial Arrhythmia Management with Sensor Controlled Atrial Refractory Period and Automatic Mode Switching in Patients with Minute Ventilation Sensing Dual Chamber Rate Adaptive Pacemakers

Although a long postventricular atrial refractory period fPVARP) may prevent the occurrence of pacemaker mediated tachycardias and inadvertent tracking of atrial arrhythmias in dual chamber (DDD) pacing, the maximum upper rate will necessarily be compromised. We tested the feasibility of using minute ventilation sensing in a dual chamber rate adaptive pacemaker (DDDR) to shorten the PVARP during exercise in 13 patients with bradycardias (resting PVARP = 463 ± 29 msec) to avoid premature upper rate behavior. Graded treadmill exercise tests in the DDD and DDDR modes at this PVARP resulted in maximum ventricular rates of 98 ± 8 and 142 ± 3 beats/min, respectively (P < 0.0001), due to chronotropic incompetence and upper rate limitation in the DDD mode, both circumvened with the use of sensor. In order to simulate atrial arrhythmias, chest wall stimulation was applied for 30 seconds at a rate of 250 beats/min at a mean unipolar atrial sensitivity of 0.82 mV. Irregular ventricular responses occurred in the DDD mode fthe rates at a PVARP of 280 and 463 ± 29 msec were, respectively 92 ± 5 and 66 ± 3 msec; P < 0.0001). In the DDDR mode at a PVARP of 463 ± 29 msec, regular ventricular pacing at 53 ± 2 beats/min occurred due to mode switching to VVIR mode in the presence of repetitive sensed atrial events within the PVARP. One patient developed spontaneous atrial fibrillation on follow-up, which was correctly identified by the pacemaker algorithm, resulting in mode switch from DDDR to regular VVIR pacing and preservation of rate response. In conclusion, sensor controlled PVARP allows a long PVARP to be used at rest without limiting the maximum rate during exercise. In addition, to offer protection against retrograde conduction, a long PVARP and mode switching also limit the rate during atrial arrhythmias and allow regular ventricular rate responses according to the physiological demands.     

A New Motion Responsive Pacemaker: First Clinical Experience with an Acceleration Sensor Pacemaker

A new accelerometer-based adaptive rate pacemaker (OEXCELVR^TM) was evaluated to investigate its behavior at nominal settings during treadmill exercise testing and postural changes. Eight patients with sinus rhythm were selected to compare intrinsic heart rate to sensor mediated rate. Throughout exercise treadmill testing, changes in the sensor mediated rate closely paralleled actual physiological changes. The Pearson product moment correlation of pacing rate with sinus frequency, calculated for all patients, was r = 0.82 (P = 0.001). Change in the patient's physical position resulted in immediate change in sensor rate, which corresponded appropriately to the type of position change and activity level. Average (± SD) pacing rate was 62.4 ± 2.7 beats/min supine; 67 ± 3.8 beats/min sitting; 69.8 ± 6.4 beats/min standing; 81.6 ± 8.7 beats/min slow walking; and 96.8 ± 1.3 beats/min fast walking. After 4 minutes of recovery, the average pacing rate dropped to 65 ± 3 beats/min. The interaction between the accelerameter and the pulse generator at nominal settings was accurate and infrequently required the use of its many programming options. The accelerometer sensor and pulse generator algorithm in this device during postural change and exercise resulted in physiological-like changes in sensor mediated heart rate.     

Adequacy of Pacing Rate During Exercise in Rate Responsive Ventricular Pacing

Our objective was to determint; the adequate pacing rate during exercise in ventricular pacing by measuring exercise capacity, cardiac output, and sinus node activity. Eighteen patients with complete AV block and an implanted pacemaker underwent cardiopulmonary exercise tests under three randomized pacing rates: fixed rate pacing (VVJ) at 60 beats/min and ventricular rate-responsive pacing (VVIR) programmed to attain a heart rate of about 110 beats/min ar 130 beats/min (VVIR 110 and VVIR 130, respectively) at the end of exercise. Compared with VVI and VVIR 130, VVIR 110 was associated with an increased peak oxygen uptake(VVIR 110:20.3 ± 4.5 vs VVI: 16.9 ± 3.1; P < 0.01; and VVIR 130: 19.0 ± 4.1 mL/min per kg, respectively; P < 0.05) and a higher oxygen uptake at anaerobic threshold (15.3 ± 2.7, 12.7 ± 1.9; P < 0.01, and 14.6 ± 2.6 mL/min per kg; P < 0.05). The atrial rate during exercise expressed as a percentage of the expected maximal heart rate was lower in VVIR 110 than in VVI or VVIR 130 (VVIR 110: 75.9%± 14.6% vs VVI: 90.6%± 12.8%; P < 0.01; VVIR 110 vs VVIR 130: 89.1%± 23.1%; P < 0.05). There was no significant difference in cardiac output at peak exercise between VVIR 110 and VVIR 130. We conclude that a pacing rate for submaximal exercise of 110 beats/min may be preferable to that of 130 beats/min in respect to exercise capacity and sympathetic nerve activity.     

Direct comparison of a contractility and activity pacemaker sensor during treadmill exercise testing

There are limited data about the chronotropic capacity of the peak endocardial acceleration (PEA) sensor. This study directly compared the chronotropic function from the PEA and the activity (ACT) sensor. The study included 18 patients (age 73 ± 7 years) with ≥ 75% pacemaker-driven heart rate (HR) and a PEA sensor and 11 healthy controls (age 67 ± 7 years) underwent a chronotropic assessment exercise protocol (CAEP) exercise test with the pacemaker patients in VVIR mode after programming the sensors in the default setting with adjustment of the upper sensor rate as an age related maximum value (220-age). The ACT sensor was externally strapped on the thorax. Achieved exercise duration for the patients and controls was, respectively, 9.2 ± 3 vs 18.4 ± 4 minutes (P < 0.001). The maximal achieved HR with the PEA sensor was 124 ± 25 beats/min, versus the ACT with 140 ± 23, versus the controls with 153 ± 26 beats/min (P < 0.001 between the groups). For the PEA, ACT, and controls, the time to peak HR was, respectively, 11 ± 3, 7 ± 3.6, and 18 ± 4 (P < 0.001 between groups) and HR after 10 minutes recovery was, respectively, 80 ± 20, 65 ± 15, and 82 ± 4 beats/min (P < 0.001 between groups). The PEA sensor functions hypochonotroop during exercise programmed as a single sensor system. It is, therefore, preferable to combine the PEA sensor with an activity-based sensor in a dual sensor system. Although both groups had normal left ventricular functions, the exercise capacity of pacemaker patients is significantly lower than in the controls.     

Lack of Physiological Adaptation of the Atrioventricular Interval to Heart Rate in Patients Chronically Paced in the AAIR Mode

Seventeen consecutive patients, aged 56 +/- 12, were chronically paced in the AAIR mode for a symptomatic sinus node disease with atrial chronotropic incompetence defined by a peak exercise heart rate (HR) less than 75% of the maximal predicted heart rate (MPHR) mean = 65 +/- 10%). Sensors used were activity sensing (n = 7), minute ventilation (n = 6), or respiratory rate (n = 4). Basic pacing rate was programmed at 71 +/- 5 beats/min and the maximal sensor rate at approximately 85% MPHR (143 +/- 10); other sensor parameters were programmed individually. Six months after implant, two standardized and symptom limited exercise tests were performed in random order, AAI and AAIR modes, respectively. AAIR pacing significantly improved peak exercise HR (139 +/- 14 vs 112 +/- 30 beats/min; P less than 0.01), maximal sustained workload (132 +/- 42 vs 110 +/- 38 watts; P less than 0.02), and total exercise duration (724 +/- 299 vs 594 +/- 245 sec; p less than 0.02) compared to the AAI mode. In all 17 patients, HR was continuously sensor driven in the AAIR mode, making it possible to precisely study the adaptation of the stimulus-R interval and of the stimulus-R:RR ratio during exercise. Six patients normally adapted with a progressive shortening. Six others did not adapt at all without any variation of interval. Five patients paradoxically increased their stimulus-R interval (286 +/- 10 msec at peak E vs 220 +/- 19 msec at rest) and their stimulus-R:RR ratio (67 +/- 20% vs 29 +/- 4%), producing P waves occurring immediately after, or even within the R wave of the preceding cycle; two patients complained of severe exercise related symptoms corresponding to the so-called "AAIR pacemaker syndrome." The principal factors involved in the nonadaptation of AV interval to HR were related to the patient (organic heart disease, with the particular problem of the denervated heart; the bradytachy syndrome; and the use of drugs, especially beta blockers and Class I antiarrhythmic drugs) or to the pacemaker ("overstimulation" phenomenon). These observations constitute an additional argument for wider indications of implanting DDDR units in these patients.     

Evaluation by Cardiopulmonary Exercise Test of DDDR Versus DDD Pacing

In eight patients (age 62 ± 6 years) a DDDR pacemaker was implanted for sick sinus syndrome (three cases) or second- and third-degree AV block (five cases). In five subjects chronotropic incompetence (maximal heart rate on effort < 110 beats/min) was present before implantation. One month after implantation the patients were randomized to DDDR or DDD pacing for 3 weeks each, with subsequent crossover, and at the end of each period a symptom limited Cardiopulmonary exercise test (25 watts/2 min) was performed and the patients were requested to fill a symptoms questionnaire. Results: DDDR pacing, compared to DDD, was associated with higher maximal heart rates (127 ± 20 vs 110 ± 27 beats/min, P < 0.02), higher (VO₂ max (25.4 ± 6.1 vs 21.5 ± 7.8 mL/kg/per min, P < 0.03) and higher VO₂ at the anaerobic threshold (20.3 ± 5.0 vs 15.8 ± 4.9 mL/kg per min, P < 0.03), without significant differences in mean exercise time (526 ± 193 vs 472 ± 216 sec, NS). The increase in VO₂ max obtained in DDDR versus DDD was significantly related to the increase in maximal heart rate (r = 0.72, P < 0.05) and the increase in VO₂ at the anaerobic threshold obtained in DDDR versus DDD was related to the increase in heart rate at the anaerobic threshold (r = 0.81, P < 0.02). In patients with chronotropic incompetence the improvement obtained in DDDR versus DDD was even more significant (VO₂ max = 22.7 ± 5.9 vs 16.1 ± 4.4 mL/kg per min, P < 0.03; VO₂ at the anaerobic threshold = 18.4 ± 5.1 vs 13.2 ± 2.8 mL/kg per min, P < 0.05; exercise time = 438 ± 132 vs 352 ± 150 sec, P < 0.02). In the population as a whole, no significant differences were found relative to subjective symptoms, meanwhile in patients with chronotropic incompetence a better subjective tolerance was apparent with DDDR than with DDD pacing. In conclusion, DDDR pacing induces a significant improvement of exercice capacity, in comparison to DDD pacing, related to the ability to reach higher heart rates during exercise. This phenomenon is particulary evident in patients with chronotropic incompetence in whom DDDR pacing also is subjectively better tolerated.     

Aerobic Capacity in Rate Modulated Pacing

Whether heart rate or AV synchrony is the most important factor for an increase in aerobic capacity was evaluated in a comparative study between sinus bradycardia, VVIR, DDD, and DDDR stimulation. Sixteen patients (mean age 67 years) with chronotropic incompetence and impJanted DDDR pacemaker (Telectronics META 1250) were randomly studied by cardiopulmonary exercise testing. All patients were exercised to their anaerobic threshold (ATJ with the following heart rates: DDD 84 ± 3, WIR 110 ± 5, and DDDR 116 ± 6 beats/min. Mean oxygen uptake (VO₂, mL/kg per min) at AT was 7.4 ± 0.3 in DDD and WIR modes. A 12% increase was measured in DDDR mode (8.3 ± 0.4). Compared to VVIR work capacity in the DDDR mode was improved by 17% (41 vs 48 W/min). In patients with isolated sinus node disease (n = 9) the increase of VO₂ and work capacity at AT during DDDR mode was more pronounced (16% and 20%, respectively, compared to VVIR). In patients with intermittent second or third degree AV block (n = 7) the differences between the pacing modes were not significant. This might partly be due to a lesser degree of chronotropic incompetence in this subgroup. In conclusion only the conjunction of heart rate increase and preservation of AV synchrony provides a significant improvement in aerobic capacity during exercise.     

Clinical Experience with an Activity Sensing DDDR Pacemaker Using an Accelerometer Sensor

The rate adaptive characteristics and pacemaker mediated tachycardia protection algorithm of an accelerometer based DDDR pacemaker were evaluated in 11 patients with bradycardia (seven atrioventricular block, four sick sinus syndrome). Rate adaptive programming was effected by collecting the acceleration level during a 3-minute moderate exercise ("tailoring" of sensor). In comparison with an externally attached piezoelectric sensor, the accelerometer sensor showed lower rate changes during external tapping of the pacemaker (16 +/- 3 vs 29 +/- 4 ppm, P less than 0.02) and applied direct pressure (1 +/- 1 vs 40 +/- 3 beats/min, P less than 0.001) on the pacemaker. At nominal setting, the accelerometer sensor showed improved rate stability and higher rate response to jogging and standing, although responses to other daily activities and treadmill exercise were similar. Apart from changing the rate responsive slope, rate response could be improved by repeat "tailoring" of the sensor at a lower exercise level, resulting in better overall rate response characteristics. The ability of the rate monitoring software to collect acceleration levels for an activity and profile the projected rate response at different rate responsive settings allowed programming to be effected with the minimum amount of exercise testing. The pacemaker also discriminated atrial tachyarrhythmias from normal sinus response using the sensor to judge the appropriateness of the atrial rate, which correctly identified and prevented rapid ventricular tracking in two patients during atrial flutter/fibrillation.     

Clinical Comparison of Acute Single to Dual Chamber Pacing in Chronotropically Incompetent Patients with Left Ventricular Dysfunction

Dual chamber, rate responsive (DDDR) pacing is felt to be superior to ventricular, rate responsive (VVIR) pacing since it more closely mimics the normal electrical and hemodynamic activity of the heart. This reasoning has been used to justify the higher initial costs and increased complexity of dual chamber systems. This study was designed to determine if objective criteria could be identified during acute testing to justify implanting a dual chamber instead of a single chamber system in patients with left ventricular dysfunction. Eight patients with DDDR pacemakers (implanted for chronotropic incompetence) and left ventricular dysfunction underwent exercise radionuclide angiography and graded exercise treadmill testing. Each patient performed the tests in the single (VVIR) and dual (DDDR) chamber modes in a randomized, blinded fashion. We found that objective parameters such as ejection fraction (31%± 13% vs 31%± 10%), exercise tolerance (6.1 ± 2.7 min vs 6.3 ± 2.9 min), oxygen consumption (VO₂) (941 ± 286 mL/min vs 994 ± 314 mL/min), carbon dioxide production (VCO₂) (995 ± 332 mL/min vs 1054 ± 356 mL/min), and maximum attainable workload (43 ± 24 W vs 46 ± 22 W) did not differ between the single and dual chamber pacing modes. These findings suggest that in the acute setting, the additional cost and complexity of dual chamber, rate responsive pacing cannot be justified by objective improvements in exercise tolerance in patients with underlying left ventricular dysfunction.     

Clinical Study of a New Activity Sensor for Rate Adaptive Pacing Controlled by Electrical Signals Generated by the Kinetic Energy of a Moving Magnetic Ball

A new rate adaptive pacemaker (Sensorithm) controlled by an activity sensor providing electrical signals induced by a magnetic ball moving freely in an elliptical cavity surrounded by two copper coils, was implanted in ten patients; mean age of 75 years (range 64–89). Six patients had atrioventricular block and four had sinus node disease. In auto-set testing procedure during a 1-minute walk in the corridor, a slope resulting in a maximum rate of 95 beats/min was selected in every patient, and a medium reaction time was programmed. During graded treadmill exercise tests the heart rate increased 63 ± 7 beats/min to 135 ± 6 beats/min in rate adaptive pacing mode (VVIR), and 15 ± 6 beats/min (P < 0.0001) in ventricular pacing mode (VVI). The symptom-limited exercise time was 9.1 ± 1.1 minutes and 8.2 ±1.2 minutes (P = NS), and the exercise distance was 501 ± 95 meters and 428 ± 92 meters (P < 0.05) in VVIR and VVI pacing mode, respectively. The maximum oxygen uptake was 20.6 ± 2.6 mL/kg per minute in VVIR pacing and 18.1 ± 2.1 mL/kg per minute (P < 0.05) in VVI pacing. The delay time until the pacing rate increased 10% of the total rate increase at onset of treadmill exercise was 4.4 ± 0.7 seconds. Assuming a linear relation between metabolic workload and heart rate response from rest to the age predicted maximum heart rate, a deviation of heart rate ranging from 13.5 ± 11.2% to –1.6 ± 5.2% from the expected heart rate at mid-point and endpoint of each quartile of workload was observed during treadmill testing. Conclusions : By using a 1 -minute walk test for selecting an appropriate slope setting, Sensorithm provided a significant and proportional heart rate increase during exercise resulting in an improvement of exercise capacity during VVIR pacing compared to VVI pacing.     

Benefits and Limitations of Rate Adaptive Pacing Under Laboratory and Daily Life Conditions in Patients with Minute Ventilation Single Chamber Pacemakers

Rate adaptive pacing has been shown to improve hemodynamic performance and exercise tolerance during acute testing. However, there remain concerns about its benefit in daily life and possible complications incurred by unnecessary pacing. This double-blind crossover study compared the benefit of rate adaptive (SSIR) versus fixed rate (SSI) pacing under laboratory and daily life conditions in 20 rate incompetent patients with minute ventilation single chamber pacemakers (META II). The heart rate (HR) response during three different exercise tests (treadmill, bicycle ergomctry, walking test) was correlated with the Holler findings during daily life in either pacing mode. The maximal HR was significantly higher in the SSIR-mode compared to the SSI-mode, both during laboratory testing (treadmill: 123 ± 15 vs 93 ± 29 beats/min: ergometry: 118 ± 15 vs 89 ± 27 beats/min; walking test: 127 ± 9 vs 95 ± 26 beats/min, all P values < 0.01) as well as during daily life (Holter: 126 ± 13 vs 103 ± 24 beats/min, P < 0.01). On Holter, the average HR (71 ± 14 vs 71 ± 8 beats/min) and the percentage of paced rhythm (54 % vs 62%, SSI- vs SSIR-mode, P = NS) were not different in either mode. However, despite a 30% rate gain in the SSIR-mode, the exercise capacity remained unchanged, and only 38% of patients preferred the SSIR-mode. Minute ventilation pacemakers provide a physiological rate response to exercise. Irrespective of the protocol used, the findings of laboratory testing are comparable to those during daily life. However, patient selection for rate adaptive single chamber pacing should be made with caution, since the objective benefit of restoring normal chronotropy may subjectively be negligible for most patients.     

A New Pacemaker for Paroxysmal Atrial Fibrillation Treated with Radiofrequency Ablation of the AV Junction

Atrial fibrillation is a relative contraindication to atrial synchronous pacing because of the risk of the tracking of rapid atrial rhythms by the pacemaker. In this study, we describe the clinical results of an AV synchronous rate responsive pacemaker with an original algorithm, which is able to sense pathological increments in atrial rate and automatically to switch into a non-AV synchronous mode of pacing. This pacemaker was implanted in 12 patients who had undergone radiofrequency ablation of the A V junction in order to cure severely symptomatic, drug refractory, paroxysmal atrial fibrillation. In an acute, intrapatient comparison between the standard AV synchronous mode and the automatic switching mode, ventricular tracking of atrial fibrillation occurred in 35% and 4% of total beats at rest and in 24% and 2% of total beats during exercise, respectively (P < 0.001). During 5 ± 4 months of follow-up, no further tachyarrhythmia related symptoms occurred. In conclusion, the standard DDDR mode is unable to eliminate ventricular tracking of atrial fibrillation, thus undermining the efficacy of AV junction ablation therapy. The automatic switching mode eliminates this adverse effect of dual chamber pacing.     

Rate Adaptive Cardiac Pacing Using Right Ventricular Venous Oxygen Saturation: Quantification of Chronotropic Behavior During Daily Activities and Maximal Exercise

Central venous oxygen saturation (S_vO_z) closely reflects cardiac output and tissue oxygen consumption. In the absence of an adequate chronotropic response during exercise, S_vO₂ will decrease and the extent of desaturation maybe used as a parameter for rate adaptive cardiac pacing. Eight patients with sinoatrial disease received a DDDR pacemaker capable of DDDR pacing by sensing either S_VO₂ or piezoelectric detected body movement. Both sensors were programmed to attain a rate of about 100 beats/min during walking, and with the lower and upper rates set at 50% and 90% of age predicted maximum, respectively. Chronotropic behavior of the two sensors were compared in the DDD mode with measurement of sensor responses, during everyday activities (walking, stair climbing, postural changes, and physiological stresses) and at each quartile of workload during a continuous treadmill exercise test. During walking at 2.5 mph, both sensors showed no significant difference in delay time (both react within 15 sees) or half-time (S_VO₂= 36 ± 12 sec and activity 24 ± 3 sec; P = NS), although S_VO₂ driven pacing achieved 90% target rate response slowerthan activity sensing (124 ± 16 sec vs 77 ± 10 sec; P < 0.02). S_VO₂ pacing was associated with a more physiological rate response during walking upslope (68 ± 12 beats/min vs 57 ± 10 beats/ min; P < 0.05), ascending stairs (59 ± 10 beats/min vs 31 ± 6 beats/min; P < 0.05), and standing (34 ± 7 beats/min vs 9 ± 2 beats/min; P < 0.05). The S_vO₂ sensor significantly overpaced in the first quartile of exercise (51.8 ± 25.6% in excess of heart rate expected from workload), but the rate was within 20% of expected for the remainder of exercise. “Underpacing” was observed with the activity sensor at the higher workload. In conclusion, the S_vO₂ sensor demonstrated a more physiological response to activities of daily living compared with the activity sensor. Using a quantitative method, the speed of onset of rate response of the S_vO₂ sensor was comparable to activity sensing, and was more proportional in rate response. Significant overpacing occurs at the beginning of exercise during S_VO₂ driven pacing, which may be improved with the use of a curvilinear algorithm.     

A Prospective Multicenter Study Demonstrating Clinical Benefit with a New Accelerometer-Based DDDR Pacemaker

From November 1994 to October 1995, 63 patients (average age 66 years; 41 men) from 15 centers implanted with the Biotronik Dromos DR and Ergos TC 03 pulse generators were prospectively screened with an exercise test in the DDD mode for the presence of chronotropic incompetence (CI). Both pulse generators incorporate an identical accelerometer-based motion sensor. CI was defined as a maximum heart rate < 60% of age predicted maximum heart rate or 100 beats/min. Twenty-five patients (40%) met the criteria for CI. Two weeks later, CI patients were required to complete paired metabolic exercise testing in the DDD and DDDR modes on consecutive days with a 24-hour rest period. The order of testing was randomized and performed double blinded to minimize potential biases. Three patients who did not reach the anaerobic threshold (AT) and one patient who was unable to perform the metabolic testing were excluded from the analysis. Compared to the DDD mode, there were statistically significant improvements in the DDDR mode for all five endpoints: heart rate (84 ± 3.6 vs 113 ± 3.5 beats/min; P < 0.0001); total exercise time (8.23 ± 0.71 vs 9.15 ± 0.65 min; P = 0.0005); maximum VO₂ (17.76 ± 1.36 vs 20.43 ± 1.75 mL/kg per min; P = 0.0001); V0₂ at AT (13.1 ± 0.87 vs 14.59 ± 0.79 mL/kg per min; P < 0.01); and exercise time to AT (5.65 ± 0.61 vs 6.33 ± 0.53 min; P = 0.02). In conclusion, the results of paired metabolic exercise tests with the Dromos DR and Ergos TC 03 pulse generators demonstrate a clear clinical benefit using the accelerometer-based sensor in the CI patient     

The Use of Implantable Sensors for the Control of Pacemaker Mediated Tachycardias: A Comparative Evaluation Between Minute Ventilation Sensing and Acceleration Sensing Dual Chamber Rate Adaptive Pacemakers

The role of implantable sensors to control pacemaker mediated tachycardias was investigated in 16 patients with two different dual chamber rate adaptive (DDDR) pacemakers, which sensed eiter minute ventilation (DDDR-Meta, nine patients) or body acceleration (Relay, seven patients). Successive atrial sensed events beyond a programmable rate occurring in the absence of detection of exercise by the sensors were considered to represent retrograde conduction or atrial arrhythmias, and the pacemakers responded by either a mode shift from DDDR to ventricular rate adaptive (VVIR) pacing (DDDR-Meta) or by tracking at an interim rate, the so-called conditional ventricular tracking limit (CVTL, Relay). In the unipolar atrial sensing mode, myopotential sensing (MPI) and external chest wall stimulations (CWS) at 250 beats/min were induced to be preferentially sensed by the atrial channel to simulate the conditions of atrial arrhythmias. In the DDD mode, these maneuvers resulted in ventricular responses of 88 +/- 3 beats/min and 110 +/- 3 beats/min for MPI and CWS, respectively. The pacing rate was significantly reduced in the DDDR mode with the sensors correctly detecting and responding to the sensed abnormal atrial signals (68 +/- 5 beats/min during MPI and 71 +/- 5 beats/min during CWS, P less than 0.005 compared with the corresponding DDD rate). One patient with a Relay pacemaker developed spontaneous atrial flutter and the ventricular tracking responses were 140 and 85 beats/min in the DDD and DDDR pacing modes, respectively. Thus MPI and CWS are useful bedside testing methods to assess pacemaker response during atrial arrhythmias. The use of implantable sensors to judge the appropriateness of atrial rate is a new approach to the management of pacemaker mediated tachycardias.     

Respiratory-Dependent Pacing: A Dual Response From A Single Sensor

Five patients with respiratory dependent rate responsive pacemakers (Biorate HDP3, Biotec) were studied using ambulatory telemetry to evaluate the sensitivity of this pacing system to nonrespiratory signals. In each case the pacemaker was implanted in the left infraclavicular position with an impedance sensing electrode inserted into the subcutaneous tissues of the anterior chest wall. The pacing rate was 73 ± 2 beats per minute at rest and rose by 42 ± 5 beats per minute when the patients were walking with both arms swinging (mean ± SEMJ. Three of the five patients had sensing electrodes that extended across the midline. In this subgoup, pacing rate rose by 26 ±4 beats per minute when walking with arms held immobile and by 36 ± 2 beats per minute during sustained voluntary hyperventilation. These same activities did not elicit any appreciable changes in pacing rate in the remaining two patients whose sensing electrodes were confined to the left hemithorax. Recordings taken from all jive patients while they were standing upright and regularly swinging one upper limb showed an increase in pacing rate of 15 + 6 beats per minute with movement of the right arm and 46 + 8 with movement of the left. These observations establish that the Biorate RDP3 pacemaker is capable of responding both to changes in respiratory rate and to movement of the upper limbs. The sensitivity to limb movement is greatest when the chest wall impedance sensor does not extend across the midline and is most evident when the arm ipsilateral to the pacemaker is swung. This anomalous response may have a profound effect on pacing rate during certain forms of exercise and must be taken into account when programming the pacemaker to meet the heart rate requirements of individual patients.     

Superior Cardiac Hemodynamics of Atrioventricular Synchrony Over Rate Responsive Pacing at Submaximal Exercise: Observations in Activity Sensing DDDR Pacemakers

LAU, C.-P., ET AL.: Superior Cardiac Hemodynamics of Atrioventricular Synchrony Over Rate Responsive Pacing at Submaximal Exercise: Observations in Activity Sensing DDDR Pacemakers. The relative hemodynamic profile between dual chamber pacing (DDD) and activity sensing rate responsive pacing (VVIR) was compared in ten patients with dual chamber rate responsive pacemakers (Synergist 11). With a double blind, randomized exercise protocol, DDDR pacemakers were programmed into VVI, VVIR, and DDD (AV interval 150 msec) modes and in seven patients the test in the DDD mode was repeated with the AV interval programmed at 75 msec. A treadmill exercise test of 6-minutes duration (2 stages, Stage 1 at 2 mph, 0% gradient and Stage II at 2 mph, 15% gradient) was performed at each of the programmed settings, with a rest period of 30 minutes in between tests. Cardiac output was assessed using continuous-wave Doppler sampling ascending aortic flow and expressed as a percentage of the value achieved during VVI pacing. During exercise, pacing rate between DDD and VVIR pacing was similar but was higher with DDD at the first minute of recovery (91 ± 4vs 81 ± 3 beat/min, respectively). Cardiac output was significantly higher at rest, during low level exercise, and recovery with DDD pacing compared with VVIR pacing (resting: 21 ± 14 vs -2 ± 7%; Stage I: 36 ± 6 vs 16 ± 7%; Stage II: 25 ± 15 vs 10 ± 8%; recovery: 26 ± 12 vs 4 ± 9%; p < 0.05 in all cases). Systolic blood pressure was significantly higher during low level of exercise in the DDD mode. Shortening of the AV interval to 75 msec did not significantly affect cardiac output during exercise, but cardiac output after exercise was reduced (2 ± 6 vs 23 ± 6% at an AV interval of 150 msec, p < 0.02). By enhancing the stroke volume, DDD pacing improves cardiac hemodynamics at rest, during low level exercise, and early postexercise recovery.     

Comparison of Continuously Recorded Sensor and Sinus Rates During Daily Life Activities and Standardized Exercise Testing: Efficacy of Automatically Optimized Rate Adaptive Dual Sensor Pacing to Simulate Sinus Rhythm

The normal sinus rhythm remains the gold standard to compare the rate response of a rate adaptive pacemaker. The aim of this study was to assess an automatically optimized dual sensor system by continuous comparison of the normal sinus (SR) and sensor indicated rates (SIR). Twelve patients with complete heart block (mean age 60 ± 9 years) with normal sinus rhythm received a dual sensor pacemaker driven by combined, automatically adaptive activity and QT sensors. After I month of automatic adaptation, patients performed a treadmill exercise in the VDD mode with simultaneous collection of SR and combined SIR. Thereafter the difference between SR and SIR was recorded over a 1-month period using a software downloaded into the pacemakers, with the patients ambulatory during this period. During exercise testing, the SR and SIR were significantly correlated (r =0.96 ± 0.02, P < 0.001), and the mean difference between SR and SIR was 4.01 ± 4.47 beats/mm. The percentages of paced beats, over the 1 month ambulatory period, that exhibited a difference between SR and SIR of 8 beats/mm were 98%± 2%, 90%± 4% and 67%± 8% for low, medium, and high workloads, respectively (P < 0.05, ANOVA). whereas > 95% of SIR were within 15 beats/min of SR independent of the level of activities. Thus, an automatically programmed dual sensor gives an accurate reflection of SR during exercise. SIR was less accurate for more vigorous daily life activities, but most of the SIR were within the normal SR variation of 15 beats/min.     

AAIR Versus DDDR Pacing in Patients with Impaired Sinus Node Chronotropy: An Echocardiographic and Cardiopulmonary Study

The aim of this study was to compare AAIR and DDDR pacing at rest and during exercise. We studied 15 patients (10 men, age 65 ± 6 years) who had been paced for at least 3 months with activity sensor rate modulated dual chamber pacemakers. All had sick sinus syndrome (SSS) with impaired sinus node chronotropy. The patients underwent a resting echocardiographic evaluation of systolic and diastolic LV function at 60 beats/min during AAIR and DDDR pacing with an AV delay, which ensured complete ventricular activation capture. Cardiac output (CO) was also measured during pacing at 100 beats/min in both pacing modes. Subsequently, the oxygen consumption (VO₂at) and VO₂at pulse at the anaerobic threshold were measured during exercise in AAIR mode and in DDDR mode with an AV delay of 120 ms. The indices of diastolic function showed no significant differences between the two pacing modes, except for patients with a stimulus-R interval > 220 ms, for whom the time velocity integral of LV filling and LV inflow time were significantly lower under AAI than under DDD pacing. At 60 beats/min, CO was higher under AAI than under DDD mode only when the stimulus-R interval was below 220 ms. For stimulus-R intervals longer than 220 ms, and also during pacing at 100 beats/min, the CO was higher in DDD mode. The stimulus-R interval decreased in all patients during exercise. The time to anaerobic threshold, VO₂at ond VO₂at pulse showed no significant differences between the two pacing modes. Our results indicate that, at rest, although AAIR pacing does not improve diastolic function in patients with SSS, it maintains a higher CO than does DDDR pacing in cases where the stimulus-R interval is not excessively prolonged. On exertion, the two pacing modes appear to be equally effective, at least in cases where the stimulus-R interval decreases in AAIR mode.