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.     

Quality-of-Life in DDDR Pacing: Atrioventricular Synchrony or Rate Adaptation?

Al though differences in exercise performance have been observed between different rate adaptive modes, the relative impact of atrioventricular (AV) synchrony and rate adaptation on quality of life (QOL) have not been determined. Thirty-three patients with either sinoatrial disease (18) or complete atrioventricular (AV) block (15) received DDDR pacemakers (16 minute ventilation sensing, 17 activity sensing). There were 11 males and 22 females, with a mean age of 66 ± 1 (range 39–78) years. The study was a double-blind, triple cross-over study comparing DDDR, DDD, and VVIR modes. At the end of each 8-week study period in each mode, QOL was assessed by a questionnaire evaluating patients' functional class (Classes I-IV), physical malaise inventory (41 items), illness perception (43 items), and overall QOL rating based on a 48 items measure covering different aspects of the patients' daily life adjustment. Two patients required early crossover from VVIR mode during the study. Patients experienced significantly fewer physi cal malaise such as temperature intolerance, dyspnea, and palpitations in the DDDR mode, compared with either DDD or VVIR pacing. DDDR pacing reduced the perception of illness in 5 of 43 items compared to VVIR pacing, and improved stamina and appetite compared to DDD pacing. The overall QOL score was 102 ± 2, 105 ± 2, 113 ± 2 in the DDDR, DDD, and VVIR modes, respectively, with a higher score indicating a poorer QOL (DDDR/DDD vs VVIR, P < 0.02). There was no change in functional classes between the three pacing modes. In conclusion, VVIR pacing has a lower QOL compared with DDD pacing, which can be further enhanced with rate augmentation.     

An Integrated Dual Sensor System Automatically Optimized by Target Rate Histogram

The use of combined sensors and advanced algorithms using different principles can improve rate performance over a single sensor system. Combinations of sensors and more sophisticated algorithms, however, invariably increase the complexity of pacemaker programming. An automatically optimized combined minute ventilation and activity DDDR pacemaker was developed to minimize repeated sensor adjustment. The device used subthreshold (below cardiac stimulation threshold) lead impedance to detect lead configuration at implantation automatically, followed by "implant management," including setting of lead polarity and initiation of DDDR pacing. Automatic sensor adaptation was achieved by programming a "target rate histogram" based on the patient's activity level and frequency of exertion, and the rate profile optimization process matched the recorded integrated sensor response to the target rate histogram profile. In nine patients implanted with the DX2 pacemakers, the implant management gave 100% accuracy in the detection of lead polarity. Rate profile optinuzation automatically increased the pacing rate during exercise between discharge and 3-month follow-up (hall walk: 78 ± 3 vs 98 ± 3 beats/min, and maximal treadmill exercise: 89 ± 6 vs 115 ± 5 beats/min, P < 0.001) with a significant increase in exercise duration during maximal exercise (7.18 ± 1 min vs 9.56 ± 2 min, P = 0.05). The accuracy of rate profile optimization versus manual programming was assessed at 1 month, and there was no significant difference between pacing rate kinetics and maximal pacing rate between the two methods of programming. In conclusion, pacemaker automaticity can be initiated at implantation and the self-optimized rate adaptive response appeared to be comparable to that derived from a manual programming procedure, which may reduce the need to perform time consuming sensor programming.     

Dual Sensor VVIR Mode Pacing: Is It Worth It?

Dual sensor ventricular demand rate responsive (VVIR mode) pacing was compared with single sensor rate responsive pacing to assess whether this new development should be more widely incorporated in modern pacemaker devices. A within patient randomized, double-blind crossover study involving ten patients, mean age 67.4 years (70% male), had Medtronic Legend Plus dual sensor VVIR pacemakers implanted for high grade A V block and chronic or persistent paroxysmal atrial fibrillation. Performance values were compared to 20 healthy control subjects of a similar age and gender. Patients were both subjectively and objectively assessed after 2 weeks of out-of-hospital activity in VVIR mode (minute ventilation sensing), VVIR mode (activity sensing), VVIR mode (dual sensor), and VVI mode (no rate response). All patients were assessed for subjective preference for, and objective improvement in, any pacing modality as assessed by standardized daily activity protocols and graded exercise treadmill testing. Subjective perception of exercise capacity and functional status was significantly lower in VVI mode (P < 0.05) compared to any of the VVIR modes, which did not differ. After completion of the study 70% of patients chose VVIR as their preferred mode, with 30% expressing no preference. Forty percent preferred activity sensor WIR mode pacing, 30% preferred dual sensor VVIR mode pacing, and 70% found either dual sensor WIR mode, minute ventilation sensor WIR mode, or both modalities least acceptable. No patient found activity sensing WIR mode least acceptable. Graded treadmill testing revealed significantly lower exercise tolerance during WI mode pacing (P < 0.01) compared to the VVIR modalities, which did not differ. Overall, chronotropic response was best with dual sensor pacing during standardized daily activity protocols and during the standard car journey. The data from this study suggest that there is no marked clinical advantage obtained from the use of dual sensor devices over current activity sensing ventricular demand rate responsive pacemakers, but with the probable added disadvantages of increased size, complexity, cost, and decreased longevity.     

A Randomized, Single-Blind Crossover Comparison of the Effects of Chronic DDD and Dual Sensor VVIR Pacing Mode on Quality-of- Life and Cardiopulmonary Performance in Complete Heart Block

The aim of this study was to compare DDD and dual sensor VVIR (activity and QT) pacing modes in complete AV block (CAVB). Eighteen patients (14 men and 4 women, aged 70 ± 6.5 years) implanted with a dual chamber, dual sensor pacemaker for CAVB with normal sinus node chronotropic function were studied. A quality-of-life and cardiovascular symptom questionnaire, and a treadmill exercise test were completed after a period of VVIR and a period of DDD pacing, each lasting 1 month. Overall quality-of-life and cardiovascular symptoms did not significantly differ, though three patients felt discomfort during VVIR mode. There was no significant statistical difference in Cardiopulmonary parameters. DDD and VVIR modes yielded the following respective data: maximum heart rate = 105.7 ± 21.8 beats/minute versus 107.6 ± 21.6 beats/minute (NS); maximum workload = 60 ± 33.4 W versus 59.3 ± 37.8 W (NS); treadmill duration = 10.1 ± 3.8 minute versus 10.1 ± 3.6 minute (NS); oxygen consumption at anaerobic threshold = 14.6 ± 4.1 ml/kg per minute versus 14.9 ± 4.6 mL/kg per minute (NS); maximum minute ventilation = 49.6 ± 9 L/min versus 46 ± 12 L/min (NS); and respiratory quotient = 1.08 ± 0.15 versus 1.08 ± 0.13 (NS). We conclude that, during a 1-month follow-up period, no difference was found between DDD and dual sensor VVIR (QT and activity) pacing modes in CAVB patients with regard to quality-of-life and Cardiopulmonary performance, though a trend toward an increased sense of well being was noted with the DDD mode.     

Comparison of Normal Sinus Rhythm and Pacing Rate in Children with Minute Ventilation Single Chamber Rate Adaptive Permanent Pacemakers

Rate adaptive pacemakers are used to achieve a better cardiac performance during exercise by increasing the heart rate and cardiac output. The ideal rate adaptive sensor should be able to mimic sinus node modulation under various degrees of exercise and other metabolic needs. Minute ventilation sensing has proven to be one of the most accurate sensor systems. In this study, alterations in sinus rhythm and pacing rates during daily life conditions in 11 children (median age 11 years, range 6–14 years) with minute ventilation single chamber pacemakers were investigated. Correlation of sinus rhythm with pacing rates was assessed. ECG records were obtained from 24–hour Holter monitoring. Average rates of five consecutive P waves and pace waves were determined every half hour. The average of the two values was then used to determine hourly rates. Correlation coefficients between the sinus rhythm and pacing rates were calculated. In nine patients, pacing rates correlated well to sinus rhythm (range 0.6793–0.9558. P < 0.001 and P < 0.05), whereas in two cases correlation was not sufficient (P > 0.05). Most of the patients, in whom rate response factor (RRF) measurements during peak exercise by treadmill with cnronotropic assessment exercise protocol were performed and pacemakers were programmed to these parameters, had more appropriate ventricular rates compared to spontaneous sinus rates. In these patients mean RRF value was 15.3 ± 2.7 (range 12–20, median 15). This study shows that during daily activities minute ventilation rate adaptive pacemakers can achieve pacing rates well correlated to sinus rhythm that reflects the physiological heart rate in children.     

Rate-Adaptive Cardiac Pacing in Children Using a Minute Ventilation Biosensor

YABEK, S.M., ET AL.: Rate-Adaptive Cardiac Pacing in Children Using a Minute Ventilation Biosensor. Chronotropic integrity is required for a normal cardiac output response to exercise. We evaluated a rate-adaptive ventricular demand pacemaker (Telectronics, META-MV) which uses minute ventilation as the sensed physiological variable for adjusting pacing rate, in seven young patients with a mean age of 11.4 years. All patients had clinically significant bradycardia related to complete heart block (n = 4) or sinus node dysfunction (n = 3). For the entire group, paced heart rates increased from 70 ± 10 beats/min to 151 ± 19 beats/min with exercise testing. The onset of rate adaptation took < 30 seconds. Changes in paced rate were linearly related to workload, VO₂ (5.9 to 20.7 mL/min/kg) and minute ventilation (8–65 L/min). The decline in pacing rate after exercise was related directly to the gradual decrease in minute ventilation and VO₂. Our data show that minute ventilation closely and accurately reflects the metabolic demands of varying workloads in children and can be used to achieve physiological, rate-adaptive pacing.     

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 Comparative Study of Activity and Dual Sensor: Activity and Minute Ventilation Pacing Responses to Ascending and Descending Stairs

Previous studies with activity-based rate; adaptive pacemakers have shown a somewhat paradoxical response when comparing ascending stairs to descending stairs. The objective of this investigation was to measure dual-sensor rate response provided by activity and minute ventilation (MV) compared with activity alone, and with a control group, during ascending and descending stairs. For dual sensor mode, measured mean peak pacing rate with 72 (92) steps per minute was 111 ± 13 beats/min (124 ± 14 beats/min) ascending stairs and 81 ± 7 beats/mm (97 ± 13 beats/min) for descending. For activity mode alone, mean peak pacing rate was 90 ± 12 beats/min (108 ± 19 beats/min) ascending stairs and 97 ± 12 beats/min (123 ±17 beats/min) descending. The mean peak control group heart rate ascending stairs for a step rate of 72 (92J steps/min were 116 ± 11 beats/min (127 ±14 beats/min) ascending stairs and for descending 89 ± 12 beats/min (95 ± 11 beats/min). While for dual sensor controlled pacing there was a significant difference for ascending and descending stairs at both step rates, there was no difference between going upstairs and downstairs for activity mode alone. Rates with dual sensor did not significantly differ from respective rates of the control group. The mean correlation coefficient between MV and paced rate was 0.85. Pacing heart rates delivered by the dual sensor mode were appropriate for ascending and descending stairs. In contrast to activity mode alone, the peak heart rates for dual sensor mode are higher during ascending than during descending stairs.     

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.     

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.     

Quality of Life in Patients with Rate Responsive Pacemakers: A Randomized, Cross-Over Study

Eleven patients with rate responsive pacemakers (7 men, 4 women, mean age 41 years with a range of 23-60) were randomly assigned to a cross-over study in order to assess their overall exercise capacity and quality-of-life (QOL) scores. All of the pacemakers were implanted for complete AV block or sick sinus syndrome. The pacemakers were randomly programmed into VVI or rate responsive (VVIR) pacing modes for 3-week study periods in each mode. At the end of each period, an exercise test was performed and the QOL was evaluated by the "Hacettepe Quality-of-Life Questionnaire". All patients exercised longer in the VVIR mode (mean 10.54 ± 0,73 min) than in the VVI mode (mean 7.81 ± 0.62 min) (P < 0.05). QOL scores were also found to be significantly higher in the VVIR mode (mean 173.81 ± 16.22 points) compared to the VVI mode (mean 156.27 ± 21.22 points) (P < 0.01). In conclusion, our results suggest that VVIR pacing offers a better QOL in addition to an improved exercise capacity, compared to the single chamber nonrate modulated pacing (VVI).     

Is Accurate Rate Response Programming Necessary?

Exercise capacity and general well-being are improved by appropriately programmed rate responsive pacemakers when compared to fixed rate units. Ten patients had activity sensing DDDR units implanted for combined AV block and sinus node incompetence. Ten patients had Sensolog activity sensing VVIR units implanted for complete heart block. The effects of over and under programming of rate response in both dual and single chamber activity sensor rate adaptive pacemakers has been assessed subjectively by visual analog scales and specific activity questionnaires and objectively by graded treadmill testing and the performance of standardized daily activities. Patients were randomly programmed to absent rate response (VVI in the Sensolog group), hyporesponsive (DDD in the dual chamber group), appropriate response (VVIR, DDDR according to Manufacturer's instructions) and over responsive (VVIR+, DDDR+) in a double-blind crossover design. Thirty percent of patients demanded early crossover from VVI, 30% from DDDR+ and 50% from VVIR+. Perception of Exercise Capability was similar to objective exercise treadmill times which were shorter in VVI than in VVIR or VVIR+ (P less than 0.05) or control subjects (P less than 0.001). There was no difference between any dual chamber mode or control subjects. General well-being was poorest in DDDR+ and VVIR+ modes despite objective improvement in exercise capacity. Symptoms were least in VVIR and DDDR and all but one patient chose appropriate programming as their overall preferred mode. Thus, even inaccurate rate response programming results in similar and improved exercise capacity compared to absent rate response but overprogramming is unacceptable to most patients, confirming that appropriate programming and sensor specificity is critical in rate responsive pacing.     

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.     

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.     

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.     

The Effect of Maximum Heart Rate On Oxygen Kinetics and Exercise Performance at Low and High Workloads

The normal heart rate is lineurly related to oxygen consumption during exercise. The maximum heart rate of the normal sinus node is approximated by the formula: HR_max= (220-age) with a variance of approximately 15%. However, the nominal upper rate of most permanent pacemakers is 120 beats/min, a value that remains unchanged for many patients. As this nominal setting falls well below the maximum predicted heart rate for most patients, it is possible that the chronotropic response of rate adaptive pacemakers during moderate und maximal exercise workloads may be less than optimal. The purpose of this study was to determine the effect of the upper programmed rate on oxygen kinetics during submaximal exercise workloads and maximum exercise performance during symptom-limited treadmill exercise. Exercise performance with an upper rate programmed to 220-age was compared with an upper rate of 120 beats/min. Eleven patients (5 men and 6 women, mean age 54 ± 10 years) with complete heart block following catheter ablation of the atrioventricular junction for refractory atrial fibrillation who were implanted with permanent, rate-modulating VVIR pacemakers comprised the study population. The rate adaptive sensors were based on activity in 8 patients, minute ventilation in 2 patients, and mixed venous oxygen saturation in 1 patient. After performing a symptom-limited treadmill exercise test to determine maximum exercise capacity and to optimize programming of the rate adaptive sensor, each subject performed two treadmill exercise tests in random sequence with a rest period of at least 1 hour between tests. During one of the tests the upper rate was programmed to a value calculated by the formula: HR_max= (220-age). During the other exercise test the upper rate was programmed to 120 beats/min. Patients were blinded as to their programmed values and to the hypothesis of the study. A novel treadmill exercise protocol was used that consisted of a 6 minute, constant-workload phase at approximately 50% of maximum workload followed immedictely by incremental, symptom-limited exercise using a modified Chronotropic Assessment Exercise Protocol (CAEP) with 1 minute stages until peak exertion. Breath-by-breath analysis of expired gases was performed with subjective scoring of exertional difficulty at the end of the constant workload phase and during each stage of incremental exercise using the Borg Perceived Exertion Scale. Exercise duration was significantly longer (6.37 ± 47 vs 611 ±48 seconds. P < 0.005) with the higher programmed upper rate. Oxygen kinetics were also significantly improved with an age predicted upper rate with a lower O₂ deficit (258 ± 88 vs 395 ± 155 ml, P = 0.002) and higher VO₂ rate constant (3.6 ± 1.0 vs 2.4 ± 0.7. P < 0.001.). The V0_2maxduring peak exertion was higher with an age predicted upper rate than with an upper rate of 120 beats/min (1807 ± 751 vs 1716 ± 702 mL/min, P = 0.01). The mean Borg score was lower during the last common treadmill stage during maximum exercise with an age predicted upper rate than with an upper rate of 120 beats/min (15.7 ± 2.0 vs 16.5 ± 1.9. P = 0.04). The mean Borg score during submaximal. constant workload exercise was also lower with a higher upper rate (9.0 ±2.5 vs 9.6 ± 2.2, P = 0.10). Programming the upper rate of rate adaptive pacemakers based on the age of the patient improves exercise performance and exertional symptoms during both low and high exercise workloads as compared with a standard nominal value of 120 beats/min.     

Benefit of Single Setting Rate Responsive Ventricular Pacing Compared with Fixed Rate Demand Pacing in Elderly Patients

In order to assess the value of a simple, single setting rate response option to VVI pacing, 12 patients (mean age 75.1 ± 6,2, range 62–83 years, seven males, five females) with symptomatic complete heart block were entered into a double-blind, randomized crossover trial of VVI versus VVIR (single setting rate responsive) pacing using Medtronic Activitrax pacemakers. Assessment was by time taken in seconds (sec) and Borg scale symptom score (6–20) for simple activities (standing from chair x 30; walking 800 meters; 52 steps on stairs [slow and fast pace], and incremental, noninclined maximal treadmill exercise), performed after a 4-week period with the patient in each pacing mode. Times were significantly improved in VVIR mode for standing from chair [mean ± SD] (78.7 ± 22.5 vs 70.7 ± 19.5 sec; P < 0.05), for 800 m walk (1032 ± 80 vs 885 ± 59 sec; P < 0.05), fast ascent of stairs (29.5 ± 7.7 vs 26.5 ± 5.6 sec; P < 0.02), and treadmill exercise (626.7 ± 189.5 vs 741.0 ± 170.2 sec, P < 0.005) although no difference in time for slow stair ascent was demonstrated. Symptom scores were significantly less in VVIR for standing from chair (12.7 ± 2.8 vs 10.3 ± 1.8; P < 0.01), 800 m walk (10.9 ± 2.7 vs 9.0 ± 2.4; P < 0.01), slow ascent of stairs (11.6 ± 2.1 vs 10.0 ± 2.0; P < 0.01), and fast ascent of stairs (13.0 ± 2.0 vs 11.7 ± 1.9; P < 0.02) but unchanged for treadmill exercise. Single setting VVIR pacing increases maximum exercise capacity and decreases perceived difficulty of submaximal exercise in elderly patients with symptomatic heart block. This would be a beneficial addition to most limited and multiprogrammable VVI systems for use in the elderly.     

Evaluation of the Temperature Response to Exercise Testing in Patients with Single Chamher, Rate Adaptive Pacemakers: A Multicenter Study

Temperature responsive pacemakers were implanted in 45 patients (ages 44 to 90); 31 patients were evaluated by randomized, paired treadmill exercise tests 1 month postimplant. Of 28 males and 17 females, 19 had coronary artery disease; 8 had congestive heart failure. Pacing indications included sinus node disease (26), atrial fibrillation (15), AV block (10), and brady/tachy syndrome (10); some had multiple indications. Blood temperature (every 10 seconds, resolution = 0.004 degrees C) and pacing rate (every minute) were telemetered from the pacemaker. Average heart rate, exercise duration (5.7 min VVI; 6.7 min VVIR), VVIR response time (22 sec), initial temperature drop (0.23 degrees C) and maximum rate of drop (0.65 degrees C/min), temperature rise (0.31 degrees C VVI; 0.38 degrees C VVIR) and rate of rise (0.27 degrees C/min) were studied in a subset of patients. In pacer-dependent patients, average paired increases in exercise duration and heart rate was 56% and 34%, respectively. Including all (31) patients, some with intermittent sinus rhythm, increases were 28% and 9%, respectively. Because exercise duration increased, temperature rise was higher with rate adaptation. Rate adaptation was obtainable in all patients and patients averaged 99 +/- 48 increases above basic pacing rate per day at nominal temperature sensitivity. Conclusion: Beneficial rate adaptation is achievable using blood temperature to modify rate in a sensor based system.     

Improvement of exercise tolerance by single lead VDD pacemaker: evaluation using cardiopulmonary exercise test

We used a cardiopulmonary test to assess the physiological benefit of single lead VDD pacing in ten patients (six men, four women; aged 32-84 years, mean 69 years) with atrioventricular block. Maximal symptom-limited treadmill exercise test using a ramp protocol was performed under VDD and VVIR or VVI pacing (VVI) in random sequence. The pacemaker was then programmed to the VDD mode, and Holter ECG was recorded in nine patients. Compared with findings during the VVI, the VDD mode had a greater chronotropic response (mean maximal heart rate, VDD 106 +/- 17 beats/min vs VVI 79 +/- 19 beats/min, P = 0.03), and was associated with prolongation of exercise duration (VDD 11.2 +/- 2.9 minute vs VVI 10.5 +/- 3.1 minute; P = 0.01), and the onset of anaerobic threshold at a higher oxygen uptake (VDD 12.4 +/- 3.4 mL/min per kilogram vs VVI 10.0 +/- 2.1 mL/min per kilogram; P < 0.01). Atrial sensing was recognized in almost all normal sinus P waves for all cases examined using Holter ECG. Thus, chronotropic response during exercise by VDD pacemaker improved exercise tolerance, indicating that a VDD pacemaker might be useful for patients requiring physical activity.