Comparative Evaluation of Rate Modulated Dual Chamber and VVIR Pacing

JUTZY, R.V., ET AL.: Comparative Evaluation of Rate Modulated Dual Chamber and VVIR Pacing. While dual chamber pacing is considered superior to VVI pacing at rest, there is a continuing debate as to the relative benefit of AV synchrony versus rate increase with exercise. To evaluate this question and to correlate different methods of evaluation, 14 patients with DDDR pacemakers were studied using serial treadmill exercise test with a CAEP protocol. Patients were exercised in DDD, DDDR, and VVIR modes. Echo-Doppler cardiac outputs were determined and pulmonary gas exchange was measured during exercise. There was a significant improvement in cardiac output with exercise in the DDDR versus VVIR modes, and in DDDR versus DDD modes in patients with chronotropic incompetence. There were small increases in exercise duration in DDDR versus VVIR modes, and small but consistent increases in VO, at all levels of exercise, though not statistically significant. In this group of patients, DDDR pacing was superior to VVIR pacing, and superior to DDD pacing when chronotropic incompetence was present.     

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.     

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.     

DDD versus VVIR Pacing in Patients,Ages 70 and Over,with Complete Heart Block

Background : Dual‐chamber pacing is believed to have an advantage over single‐chamber ventricular pacing. The aim of the study was to determine whether elderly patients with implanted pacemaker for complete atrioventricular block gain significant benefit from dual‐chamber (DDD) compared with single‐chamber ventricular demand (VVIR). Methods : The study was designed as a double‐blind randomized two‐period crossover study—each pacing mode was maintained for 3 months. Thirty patients (eight men, mean age 76.5 ± 4.3 years) with implanted PM were submitted to a standard protocol, which included an interview, functional class assessment, quality of life (QoL) questionnaires, 6‐minute walk test, and transthoracic echocardiographic examinations. QoL was measured by the SF‐36. All these parameters were obtained on DDD mode pacing and VVIR mode pacing. Paired data were compared. Results : QoL was significantly different between the two groups and showed the best values in DDD. Overall, no patient preferred VVIR mode, 18 preferred DDD mode, and 12 expressed no preference. No differences in mean walking distances were observed between patients with single‐chamber and dual‐chamber pacing. VVI pacing elicited marked decrease in left ventricle ejection fraction and significant enlargement of the left atrium. DDD pacing resulted in significant increase of the peak systolic velocities in lateral mitral annulus and septal mitral annulus. Early diastolic velocities on both sides of mitral annulus did not change. Conclusion : In active elderly patients with complete heart block, DDD pacing is associated with improved quality of life and systolic ventricular function compared with VVI pacing. (PACE 2010; 583–589)     

Pacemaker Electrocardiography of Rate Smoothing During DDD Pacing

A rate smoothing option is available in a new bipolar AV universal (DDD) pacemaker. In three patients, two with intact retrograde conduction and one with retrograde block, rate smoothing values of 3% and 6% were programmed. Irregular pacemaker-mediated tachycardia occurred in one patient and AV synchrony was temporarily lost in the other two patients. In this report, we describe the pacemaker electrocardiography of rate smoothing during DDD pacing.     

Failure to Sense P Waves During DDD Pacing

ECG tracings of three patients in whom AV universal (DDD) pacemakers were implanted intermittently demonstrated dropped P waves. In one patient, true atrial undersensing was present; in the others, sensing of the atrial electrode was appropriate, but sensing of sinus P waves was intermittently blocked by normal pacemaker operation. In this report we discuss the electrocardiographic diagnosis of atrial undersensing in order to avoid unnecessary reinterventions.     

Dynamic Electrophysiology of Ventriculoatrial Conduction: Implications for DDD and DDDR Pacing

CAZEAU, S., ET AL.: Dynamic Electrophysiology of Ventriculoatrial Conduction: Implications for DDD and DDDR Pacing. The behavior of ventriculoatrial conduction (VAC) during exercise remains unknown. In order to determine its characteristics and the consequences it might have on dual chamber pacemaker technology and programming, 17 patients underwent an electrophysiological study (EPS) of atrioventricular conduction (AVC) and of VAC during a protocol including three steps: supine rest, upright position, and finally during cycloergometric exercise; the measurements were done at progressively increasing pacing rates. During a preimplantation EPS, Wenckebach points AVC-W and VAC-W and conduction times, AVCT and VACT (as a function of pacing rate), were measured in ten consecutive patients using temporary leads and an external device. In another study, AVCT, VACT, AVC-W, and VAC-W were measured by telemetric recordings under identical conditions in seven patients implanted earlier with a DDD pacemaker. A 1/1 VAC was observed in 7/17 patients (41%) at rest, and in 13/17 patients (76%) at the end of the protocol; VAC was never observed in 4/17 patients [23%], but occurred in six of the ten patients initially free, three standing at rest and three on exercise. For all patients, the VAC behavior remained of “nodal” type, indicated by a progressive increase in VACT as pacing rate rose up to the VAC-W point. Neither the existence of exercise-induced VAC nor the maximal VACT-W could be predicted from AVC or VAC data obtained at rest. However, at the same pacing rates, standing up and exercise induced a shortening effect on VACT, and improved the VAC-W by an average of 33%. These results suggest that the electrophysiological behavior of VAC does not obey any general rule and cannot be predicted individually. It would thus appear unwise to base pacemaker mediated tachycardia (PMT) protection solely on long postventricular atrial refractory period (PVARP) programming in DDD patients. This work also revealed the potential risks of a rate responsive auto-adaptive PVARP algorithm as proposed in certain new devices.     

Dual Chamber Pacing with a Single-Lead DDD Pacing System

The successful application of single-lead VDD pacing during the last few years has generated the idea of single-lead DDD pacing. Preliminary data from several single-lead VDD studies attempting to pace the atrium by a floating atrial dipole are unsatisfactory, causing an unacceptably high current drain of the device. We studied the feasibility as well as the short- and long-term stability of atrioventricular sequential pacing, using a new single-pass, tined DDD lead. In eight consecutive patients (age 73+/-16 years) with symptomatic higher degree AV block and intact sinus node function, this new single-pass DDD lead was implanted in combination with a DDDR pacemaker. Correct VDD and DDD function was studied at implantation; at discharge; and at 1, 3, and 6 months of follow-up. At implant, the atrial stimulation threshold was 0.6+/-0.1 V/0.5 ms. During follow-up, the atrial pacing thresholds in different every day positions averaged 2.1+/-0.5 V at discharge, 2.9+/-0.5 V at 1 month, 3.8+/-0.4 V at 3 months, and 3.4+/-0.4 V at 6 months (pulse width always 0.5 ms). The measured P wave amplitude at implantation was 4.5+/-2.2 mV; during follow-up the telemetered atrial sensitivity thresholds averaged 2.1+/-0.3 mV. Phrenic nerve stimulation at high output pacing (5.0 V/0.5 ms) was observed in three (38%) patients at discharge and in one (13%) patient during follow-up; an intermittent unmeasurable atrial lead impedance at 3 and 6 months follow-up was documented in one (13%) patient. This study confirms the possibility of short- and long-term DDD pacing using a single-pass DDD lead. Since atrial stimulation thresholds are still relatively high compared to conventional dual-lead DDD pacing, further improvements of the atrial electrodes are desirable, enabling lower pacing thresholds and optimizing energy requirements as well as minimizing the potential disadvantage of phrenic nerve stimulation.     

Intrapatient Comparison Between Chronic VVIR and DDD Pacing 'In Patients Affected by High Degree AV Block Without Heart Failure

MENOZZI, C., ET AL.: Intrapatient Comparison Between Chronic VVIR and DDD Pacing in Patients Affected by High Degree AV Block Without Heart Failure. In patients affected by high degree AV block without preexisting congestive heart failure there is no definite demonstration that DDD pacing gives real clinical advantages in respect to VVIR pacing. We performed an intrapatient, long-term study between the two pacing modes in 14 high degree AV block patients, using the Medtronic Synergyst 7027 dual chamber pacemaker, who could be programmed alternatively in DDD or VVIR mode. After a 4-week run-in period following the pacemaker implant, patients completed a randomized, double-blind, cross-over study to compare the effect of 6-week period VVIR and DDD pacing on symptoms and cardiovascular parameters. A semiquantitative score scale was used to quantify the symptoms of general well-being, palpitations, dizziness, pulsating sensation in the neck or abdomen, shortness of breath at rest and during effort, chest pain, and NYHA classification. The sum of symptom scores was 10.4 ± 6.7 in VVIR period and 4.6 ± 2.7 in DDD period (p < 0.001); five patients (36%) crossed over early from VVIR to DDD because of intolerable symptoms; overall, eight patients preferred the DDD mode and no one preferred the VVIR. Cardiac output at rest (echo-Doppler method) was 4.7 ± 1.4 versus 5.7 ± 1.6 liter/min (p < 0.01), body weight was 65.9 ± 6.6 versus 64.9 ± 6.1 kg (p < 0.02), atrial natriuretic peptide was 236 ± 112 versus 198 ± 110 pg/mL (p < 0.01), respectively, during VVIR and DDD modes. Effort tolerance was similar with the two modes of pacing (68 ± 15 vs 70 ± 18 watt/min). In conclusion, hemodynamic advantages of atrial synchronization reflect a better quality of life for the patients even if an individual variability exists.     

A Comparison of VVIR and DDDR Pacing Following Cardiac Transplantation

We compared the clinical course of patients paced in VVIR versus DDDR mode to determine the most appropriate method of pacing following cardiac transplantation. Pacemaker implantation was required in 9 of 90 orthotopic cardiac transplants (10%). Indications included sinus bradycardia or sinus arrest (8 patients) and AV node dysfunction (1 patient). VVIR pacemakers were implanted in four patients and DDDR in five patients. DDDR patients : The mean P wave was 1.7 mV and the mean atrial stimulation threshold was 0.8 V (at 0.5 msec). During follow-up of 20 months, two atrial lead complications developed (29% of leads in 33% of patients). No lead complications were directly related to endomyocardial biopsy. VVIR patients : All four patients developed VA conduction with mean VA time 180 msec (160–240 msec). Two patients developed pacemaker syndrome. Conclusions : VA conduction and pacemaker syndrome may develop in cardiac transplant recipients paced in the VVIR mode. Dual chamber pacing is technically feasible and preferable following cardiac transplantation.     

Rate Adaptive Atrial Pacing in the Bradycardia Tachycardia Syndrome

In 42 patients (26 men, 16 women; mean age 69 ± 10 years), who were paced and medicated with antiarrhythmic drugs for the bradycardia tachycardia syndrome, chronotropic response and AV conduction with rapid atrial pacing during exercise were studied. Patients were included if they had no second- or third-degree AV block, no complete bundle branch or bifascicular block, and a PQ interval ≤ 240 ms during sinus rhythm at rest. The interval between the atrial spike and the following Q wave (SQ) was measured in the supine position at rest with an AAI pacing rate of 5 beats/min above the sinus rate (SQ-R+5), and at the end of exercise with 110 beats/min (SQ-E110). Bicycle ergometry was performed using the Chronotropic Assessment Exercise Protocol with the pacemakers being programmed to AAI with a fixed rate of 60 beats/min. Chronotropic incompetence was defined as peak exercise heart rate: (1) < 100 beats/min; (2) < 75% of the maximum predicted heart rate; or (3) the heart rate at half the maximum workload < 60 + 2 beats/min per mL O₂/kg per minute (calculated O₂ consumption). During exercise, one patient developed atrial fibrillation. Chronotropic incompetence was present in 71 % (29/41) of the patients according to definition 2, and in 76% (31/41) according to definition 1 or 3. Ten out of 41 patients (24%) exhibited a second-degree AV block with atrial pacing at 110 beats/min at the end of exercise. Only 9 out of the remaining 31 patients (29%) showed a physiological adaptation of the SQ-E110, and 21 patients (68%) exhibited a paradoxical increase of the SQ interval with rapid atrial pacing at the end of exercise as compared to the SQ-R+5. These observations indicate that the pacing system to be used in most patients paced and medicated for the bradycardia tachycardia syndrome should be dual chamber, and the option of rate adaptation should be considered.     

Reduction of right ventricular pacing in patients with sinus node dysfunction using an enhanced search AV algorithm

BACKGROUND: Dual chamber pacing typically results in a high percentage of ventricular pacing. A number of studies have been conducted suggesting detrimental effects of ventricular desynchronization produced by long-term RV pacing. Pacemaker algorithms that extend the AV interval to uncover intrinsic AV conduction have been utilized to reduce ventricular pacing. These algorithms are often limited to AV intervals below 250 ms limiting the ventricular pacing reduction. We hypothesized that by allowing AV intervals to extend beyond 300 ms, a marked reduction in RV pacing can be achieved. METHODS: A total of 30 patients (17 men, mean age 71 +/- 9) with standard Brady indications, and implanted with a Medtronic Kappa 700 pacemaker, were randomized to 2-week treatments with default Search AV (KSAV) parameters or Enhanced Search AV (ESAV) parameters. The Enhanced Search AV algorithm included the capability for continuous adjustment of AV delays and the ability to auto disable in patients with persistent AV block. RESULTS: Among patients with intact AV conduction, percent VP was greater in KSAV versus ESAV (70 +/- 40% vs 19 +/- 28%, P < 0.001). In patients with persistent AV block, the algorithm suspended appropriately and there was no significant change in the percent VP between both arms of the study. In 18/22 patients, percent VP was reduced below 40%. CONCLUSIONS: Substantial reduction in ventricular pacing can be achieved by allowing the AV interval parameters to extend beyond 300 ms using the ESAV algorithm. In patients with AV block, ESAV suspended and patients were paced at their nominal settings.     

Atrial Pacing: Efficacy and Safety

Atrial pacing has the advantages of simplicity, maintenance of AV synchrony, and economy. The major detraction has been the potential for deterioration of atrioventricular conduction. In this study, we followed 43 patients with sick sinus syndrome treated with atrial (AAI) pacing. Excellent initial implant parameters were obtained in all. Three early lead repositionings were required. Minor sensing and pacing problems could all otherwise be handled by reprogramming. FoIIow-up for a mean of 25 ± 20 months demonstrated excellent performance of the pacing systems. Pacing and sensing thresholds and lead impedance indicated excellent lead performance. There were no late lead failures. Nine patients have had mild deterioration in atrioventricular conduction and one of these had a change to DDD pacing at the time of elective battery change. All patients are asymptomatic. Thus, chronic atrial pacing in selected patients is safe and reliable with good chronic lead performance and low risk of subsequent conduction system disease.     

Atrial Pacing: Who do We Pace and What do We Expect? Experiences with 100 Atrial Pacemakers

The records of 100 patients with permanent atrial pacemakers implanted over a 7-year period were reviewed to assess the role and results of this mode of pacing. Indications for pacing were sick sinus syndrome in 91, carotid sinus hypersensitivity in 3, and use of an antitachycardia device in 6 patients. The mean follow-up period was 32.9 months. Symptomatic relief was good. Lead dislodgment occurred in 11 patients (usually in the first week). Threshold rises not amenable to reprogramming occurred in three patients and loss of sensing occurred in seven patients but only one required intervention. Overall, 21 patients required reoperation. The type of lead did not influence the need for reoperation that appeared to be related to the experience of the operator. Complete atrioventricular block occurred in three patients, two of whom had carotid sinus hypersensitivity and one had sick sinus syndrome. Chronic atrial fibrillation occurred in five patients, none of whom required revision of the pacemaker system. Atrial pacing is a satisfactory pacing mode in patients with sick sinus syndrome. Provided satisfactory atrioventricular conduction has been shown by incremental atrial pacing to at least 120 beats/min and carotid hypersensitivity is absent, progression to complete atrioventricular block is uncommon. Greater implanting skills are required for good results.     

Pacing for Carotid Sinus Syndrome and Sick Sinus Syndrome

BRIGNOLE, M., ET AL: Pacing for Carotid Sinus Syndrome and Sick Sinus Syndrome. The real incidence of pacemaker implants for carotid sinus syndrome (CSS) and the relation between CSS and sick sinus syndrome (SSS) is not precisely known. Patients who needed pacing therapy because of atrial bradyarrhythmias were investigated by means of carotid sinus massage, dynamic ECG, and invasive electrophysiological sinus node evaluation. Of 298 consecutive patients receiving a pacemaker implant, 36 (12%) had a severe cardioinhibitory carotid sinus reflex with reproducible spontaneous symptoms (CSS), 33 (11%) had sinus bradycardia < 50 beat/min or an abnormal electrophysiological evaluation (SSS) and 24 (8%) had both (CSS + SSS). The annual incidence was 40, 37, and 26, respectively, implants per year/million of inhabitants (total incidence 325). Patients affected by CSS, if compared with those affected by SSS, showed: a higher prevalence of syncope (97% vs 42%); more syncopal, episodes per patient (2.9 ± 2 vs 1.8 ± 0.9); a lower prevalence of associated cardiac diseases (53% vs 100%); cardiac enlargement (36% vs 88%); heart failure (6% vs 36%) and paroxysmal atrial fibrillation (0% vs 42%); and a more frequent indication for VVI pacing (75% vs 3%). In patients with CSS + SSS, intermediate characteristics were present. In conclusion, CSS is as frequent an indication to cardiac pacing as SSS; clinical differences justify a distinction between them, even if they are associated in 26% of cases.     

Ventricular Pacing in Children

Ventricular pacing in children. Ventricular pacing was performed in forty-one children ranging from one day to twenty years of age (median age = 10). Weight of the recipient at implant ranged from 2 kg. to 86 kg. Indications included presyncope, syncope, dyspnea on exertion, congestive heart failure, postoperative infra-Hisian heart block, and inadequate cardiac rate during pharmacotherapy. Four patients died during follow-up, but no deaths were attributable to pacemaker management. In contrast, 66% of the patients required more than one pacemaker related-operative procedure, and 43% of leads implanted failed by 48 hours. Indications for permanent cardiac pacing in this population at this time are symptomatic congenital AV block, symptomatic sinus node disease, and AV block in the postoperative period. Technological developments which might reduce complications seen in this population and electrophysiologic techniques which may better define indications for pacing in children are also reviewed.     

Hemodynamic Findings During Sinus Rhythm, Atrial and AV Sequential Pacing Compared to Ventricular Pacing In a Dog Model

The hemodynamic responses of atrial lAF], atrioventricu-lar sequential (AVP) and ventricuJar pacing (VP) were compared to sinus rhythm (SfiJ in seventeen anesthetized dogs with intact AV conduction. The atrium and/or ventricle were paced at fixed rates above the control sinus rate. An AV interval shorter than normal conduction was selected to capture the ventricle. The changes of pulmonary capillary wedge pressure (PCWP, mmHg). mean aortic pressure (MAP, mmHg), cardiac output (CO, L/min), systemic vascular resistance (SVR, dynes/s/cm⁻⁵), left ventricular stroke work index (SWI) and mean systolic ejection rate (MSER, ml/s) during sinus rhythm, atrial pacing and atrio-ventricular sequential pacing (expressed in percentages of the individual values during ventricular pacing) were:
The importance of atrial systole for cardiac performance was clearly demonstrated in dogs with normally compliant hearts. In both atrial and atrioventricular sequential pacing compared to ventricular pacing there was a reduction of pulmonary capillary wedge pressure (PCWP) (p < 0.01) and systemic vascular resistance (SVR) (p < 0.01) despite an increase in cardiac output (CO). The lesser mean systolic ejection rate (MSER) found during atrioventricular sequential pacing compared to sinus rhythm and atrial pacing may be explained by the abnormal ventricular depolarization in this pacing mode; nevertheless, the mean systolic ejection rate was still greater than that found during ventricular pacing (p < 0.05).     

Near elimination of ventricular pacing in SafeR mode compared to DDD modes: a randomized study of 422 patients

Aims: SafeR performance versus DDD/automatic mode conversion (DDD/AMC) and DDD with a 250‐ms atrioventricular (AV) delay (DDD/LD) modes was assessed toward ventricular pacing (Vp) reduction. Methods: After a 1‐month run‐in phase, recipients of dual‐chamber pacemakers without persistent AV block and persistent atrial fibrillation (AF) were randomly assigned to SafeR, DDD/AMC, or DDD/LD in a 1:1:1 design. The main endpoint was the percentage of Vp (%Vp) at 2 months and 1 year after randomization, ascertained from device memories. Secondary endpoints include %Vp at 1 year according to pacing indication and 1‐year AF incidence based on automatic mode switch device stored episodes. Results: Among 422 randomized patients (73.2 ± 10.6 years, 50% men, sinus node dysfunction 47.4%, paroxysmal AV block 30.3%, bradycardia‐tachycardia syndrome 21.8%), 141 were assigned to SafeR versus 146 to DDD/AMC and 135 to DDD/LD modes. Mean %Vp at 2 months was 3.4 ± 12.6% in SafeR versus 33.6 ± 34.7% and 14.0 ± 26.0% in DDD/AMC and DDD/LD modes, respectively (P < 0.0001 for both). At 1 year, mean %Vp in SafeR was 4.5 ± 15.3% versus 37.9 ± 34.4% and 16.7 ± 28.0% in DDD/AMC and DDD/LD modes, respectively (P < 0.0001 for both). The proportion of patients in whom Vp was completely eliminated was significantly higher in SafeR (69%) versus DDD/AMC (15%) and DDD/LD (45%) modes (P < 0.0001 for both), regardless of pacing indication. The absolute risk of developing permanent AF or of remaining in AF for >30% of the time was 5.4% lower in SafeR than in the DDD pacing group (ns). Conclusions: In this selected patient population, SafeR markedly suppressed unnecessary Vp compared with DDD modes. PACE 2012; 35:392–402)     

A Double-Blind Study of Submaximal Exercise Tolerance and Variation in Paced Rate in Atrial Synchronous Compared to Activity Sensor Modulated Ventricular Pacing

To assess the variation in paced rate during everyday activity and the importance of atrioventricular synchronization (AV synchrony) for submaximal exercise tolerance, atrial synchronous (DDD) and activity rate modulated ventricular (VVI,R) pacing were compared in 17 patients with high degree AV block. The patients were randomly assigned to either mode and evaluated by treadmill exercise to moderate exertion and by 24-hour Holter monitoring after 2 months in the DDD and VVI,R modes, respectively. At the end of the study, the patients were programmed to the pacing mode corresponding to the preferred study period. During the treadmill test, the mean exercise time to submaximal exertion (Borg 5/10), exertion ratings and respiratory rate did not differ between pacing modes despite a significantly lower ventricular rate in the VVI,R mode. The atrial rate during VVI,R pacing was significantly higher than the ventricular rate, but did not differ from the ventricular rate during DDD pacing. There was a diurnal variation in paced rate in both pacing modes. Paced ventricular rate was, however, higher and variation in paced rate greater in DDD compared to VVI,R pacing. Nine patients preferred the DDD mode, three patients preferred the VVI,R mode, while five subjects did not express any preference. The results from this study indicate that the variation in paced rate during activity sensor-driven VVI,R pacing does not match that during DDD pacing neither during everyday activities nor during submaximal treadmill exercise. Nevertheless, no differences in exercise time, Borg ratings, and respiratory rate during submaximal exercise were found. Thus, for most patients with high degree AV block, DDD and VVI,R pacing seem equally satisfactory for submaximal exercise.