Very Low Ventricular Pacing Rates Can Be Achieved Safely in a Heterogeneous Pacemaker Population and Provide Clinical Benefits: The CANadian Multi-Centre Randomised Study-Spontaneous AtrioVEntricular Conduction pReservation (CAN-SAVE R) Trial.

BACKGROUND: It is well recognized that right ventricular apical pacing can have deleterious effects on ventricular function. We performed a head-to-head comparison of the SafeR pacing algorithm versus DDD pacing with a long atrioventricular delay in a heterogeneous population of patients with dual-chamber pacemakers. METHODS AND RESULTS: In a multicenter prospective double-blinded randomized trial conducted at 10 centers in Canada, 373 patients, age 71±11 years, with indications for dual chamber DC pacemakers were randomized 1:1 to SafeR or DDD pacing with a long atrioventricular delay (250 ms). The primary objective was twofold: (1) reduction in the proportion of ventricular paced beats at 1 year; and (2) impact on atrial fibrillation burden at 3 years, defined as the ratio between cumulative duration of mode-switches divided by follow-up time. Statistical significance of both co-primary end points was required for the trial to be considered positive. At 1 year of follow-up, the median proportion of ventricular-paced beats was 4.0% with DDD versus 0% with SafeR (P<0.001). At 3 years of follow-up, the atrial fibrillation burden was not significantly reduced with SafeR versus DDD (median 0.00%, interquartile range [0.00% to 0.23%] versus median 0.01%, interquartile range [0.00% to 0.44%], respectively, P=0.178]), despite a persistent reduction in the median proportion of ventricular-paced beats (10% with DDD compared to 0% with SafeR). CONCLUSIONS: A ventricular-paced rate <1% was safely achieved with SafeR in a population with a wide spectrum of indications for dual-chamber pacing. However, the lower percentage of ventricular pacing did not translate into a significant reduction in atrial fibrillation burden. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov/ Unique identifier: NCT01219621.

Impact of AV conduction disorders on SafeR mode performance.

PURPOSE: CAN-SAVE R is a Canadian multicenter study that compares the effects of a new pacing mode algorithm designed to minimize right ventricular (V) pacing versus DDD mode with a long atrioventricular (AV) delay in a general population of pacemaker (PM) recipients. STUDY PARTICIPANTS: Patients with permanent atrial fibrillation (AF) or high-degree AV block (AVB) were excluded. We present preliminary data collected in 208 patients (mean age=71 +/- 11 years, 68% men), for the 2-month baseline period during which all PM were programmed in the new pacing mode. The pacing indications were sinus node disease (SND) without AVB in 39%, AVB without SND in 30%, SND and AVB in 16%, and miscellaneous in 15% of patients. RESULTS: The mean percent V pacing in the overall population was 9.5 +/- 23.8% (range=0-100%, median <1%), ranging between 0.5 +/- 1.5% (median=0) in patients without AVB and 18.7 +/- 31.2% in patients (median = 1) with AVB. Adverse events potentially related to the new pacing mode were observed in two patients with AVB. CONCLUSIONS: A new pacing mode was effective and safe in a general population of PM recipients without permanent AVB and was associated with an overall <1% median V pacing. CAN-SAVE R will compare the long-term effects of the new pacing mode with DDD with a long AV delay on clinical outcomes and cardiac function.

Prevention of inappropriate shocks in ICD recipients: a review of 10,000 tachycardia episodes.

BACKGROUND: The efficacy of dual-chamber ICD arrhythmia classification algorithms is crucial to prevent inappropriate shocks. We report our experience from a meta-analysis of five prospective clinical studies with inclusion phases ranging between 1997 and 2003. METHODS: Dual-chamber ICD using standard dual-chamber arrhythmia classification algorithms were implanted in 802 patients (mean age = 64 +/- 11 years, 88% men) in 74 medical centers. The ICD indication was secondary prevention in 95% of patients. Supraventricular tachyarrhythmias (SVT) were previously documented in 26% of patients. All spontaneous tachyarrhythmic events documented by the device memories were analyzed by a adjudicating committee. The episodes lasting > 12 seconds and/or treated by the ICD were analyzed. RESULTS: Over a mean follow-up of 302 +/- 113 days, 9,690 events were reported. Mean heart rate at the time of events was 131 +/- 45 bpm (100-430). Events were classified as oversensing in 1.4%, sinus tachycardia (ST) in 66%, SVT in 13%, slow (< 150 bpm) ventricular tachycardia (VT) in 8.7%, and VT or ventricular fibrillation (VF) in 10.3%. The sensitivity of slow VT detection was 94%, and of VT/VF detection 99.3%. The specificity of sinus rhythm/ST/SVT recognition was 94%, positive predictive value 79.3%, and negative predictive value 99.2%. A total of 1,918 episodes were treated in 330 patients: 1,472 appropriately in 213, and 446 inappropriately in 117 (15% of the overall population) patients. Only 62 episodes were inappropriately treated by shocks in 40 patients, representing 5% of the overall population. CONCLUSIONS: In this conventional ICD population, the overall specificity of standard dual-chamber arrhythmia detection settings reached 94%. This feature allows efficient detection of fast as well as slow VT events with a very low rate of inappropriate shocks.

AAIsafeR limits ventricular pacing in unselected patients.

INTRODUCTION: Dedicated pacing modes, such as AAIsafeR, prevent ventricular (V) pacing in selected patients. We report our experience in consecutive unselected patients. METHODS: All data collected in recipients of Symphony DR 2550 pacemakers (ELA Medical, Montrouge, France) were retrospectively analyzed. At each visit, the percentage of V and atrial (A) pacing and the number of endless-loop tachycardia (ELT) episodes detected by the device were retrieved. Data were pooled according to pacing mode and compared with non-paired Student's t-test. Between April 2004 and July 2005, our center recruited 147 patients (mean age = 80 +/- 9 years, 54% men) treated for AV block (n = 58), sinus node dysfunction (n = 48) or other indications (n = 41). Mean age at implant was 80 +/- 9 years, and 54% were men. AAIsafeR(R) was programmed in 96 patients, DDD(R) in 43, DDI in 7, and DDD/AMC in 1 patient. In DDD mode, the mean resting AV delay was set at 150 +/- 17 ms. Patients were seen 1 month after implantation of the pacing system to verify its proper function, and every 6 months thereafter. At each follow-up, the percentage of ventricular and atrial pacing, and the number of ELT detected by the device, were recorded. RESULTS: The mean follow-up was 7 +/- 6 months (range 1-21). No device was reprogrammed from AAIsafeR(R) to DDDI(R) because of permanent AF. Only 6 devices (6.25%) were automatically reprogrammed from AAIsafeR(R) to DDD(R) during follow-up due to permanent AV block. An empirical choice of AAIsafeR pacing mode at the time of implantation was effective in 94% of patients, allowing a significant decrease in the percentage of V pacing. AAIsafeR versions 1 or 2 significantly decreased the percentage of V pacing (9 +/- 21%) compared with DDD (95 +/- 14%), DDD/AMC (31 +/- 34%), and DDI (87 +/- 20%) pacing (P < 0.00001). The mean percentage of V pacing was 12 +/- 24% (median 0%, range 0-94) in AAIsafeR1 versus 4 +/- 12% (median 0%, range 0-52) in AAIsafeR2 (P = .055). In 16 devices upgraded from AAIsafeR version 1 to version 2, with follow-up analyzable in both modes, the mean percentage of V pacing decreased from 6.4 +/- 15.1% to 2.6 +/- 9.7% (ns). No adverse effect related to the AAIsafeR modes was observed. No patient reported palpitation, dyspnea, or lightheadedness attributable to overdrive pacing by the AF prevention algorithms, and there was no rehospitalization, need for cardioversion, device-related complication, or death. CONCLUSIONS: In unselected pacemaker recipients, AAIsafeR reliably prevented V pacing compared with other pacing modes. No adverse effects were reported by any patient. Furthermore, maintaining spontaneous AV conduction protected the patients against ELT episodes.

Incidence and predictive factors of atrial fibrillation in paced patients.

We have designed a prospective observational study to analyze the incidence and predictive factors of atrial fibrillation (AF) during a long follow-up, in a large population. Atrial fibrillation episodes were documented by the fallback mode switch (FMS) provided by implanted pacemakers. We have included 377 patients (61% men). The pacing indications were atrioventricular (AV) block (49%), sinus node disease (SND, 16%), bradycardia-tachycardia syndrome (BTS, 5%), AV block + SND (19%), AV block + BTS (6%), and BTS + SND (5%). The mean age at implant was 75 +/- 12 (range 28-95). Atrial fibrillation before inclusion was documented in 10% of patients. Drug therapy at first follow-up included beta-adrenergic blockers (17% of the patients), amiodarone (13%), and others (16%). The mean follow-up was 30 +/- 24 weeks. At least one AF episode was stored during follow-up in the memory of 169 pacemakers (45%). Among patients without history of AF at implant, 46% had documented FMS during follow-up. Patients with AF received more antiplatelet medications than patients without AF (P = 0.03). In patients with AF, New York Heart Association functional class was slightly higher, amiodarone and sotalol were more often prescribed, and the proportion of hypertension was higher than in patients without AF. However, these trends were not statistically significant. A significant higher incidence of premature atrial beats was observed in patients with AF than patients without AF (P < 0.0002). Patients with AF had a lower atrial percentage of paced events (55%) than patients without AF (63%, P < 0.02). These preliminary results confirm the high incidence of AF in paced patients and suggest a preventive effect of atrial pacing. The effects of other clinical variables may be confirmed with a longer follow-up in a larger population.

Enhanced specificity of a dual chamber ICD arrhythmia detection algorithm by rate stability criteria.

Inappropriate therapy remains an important limitation of implantable cardioverter defibrillators (ICD). PARAD+ was developed to increase the specificity conferred by the original PARAD detection algorithm in the detection of atrial fibrillation (AF). To compare the performances of the two different algorithms, we retrospectively analyzed all spontaneous and sustained episodes of AF and ventricular tachycardia (VT) documented by state-of-the-art ICDs programmed with PARAD or PARAD+ at the physicians' discretion. The results were stratified according to tachycardia rates <150 versus > or =150 beats/min. The study included 329 men and 48 women (64 +/- 10 years of age). PARAD was programmed in 263, and PARAD+ in 84 devices. During a mean follow-up of 11 +/- 3 months, 1,019 VT and 315 AF episodes were documented among 338 devices. For tachycardias with ventricular rates <150 beats/min, the sensitivity of PARAD versus PARAD+ was 96% versus 99% (NS), specificity 80% versus 93% (P < 0.002), positive predictive value (PPV) 94% versus 91% (NS), and negative predictive value (NPV) 86% versus 99% (P < 0.0001). In contrast, in the fast VT zone, the specificity and PPV of PARAD (95% versus 84% and 100% versus 96%) were higher than those of PARAD+ (NS, P < 0.001). Among 23 AF episodes treated in 16 patients, 3 episodes triggered an inappropriate shock in 3 patients, all in the PARAD population. PARAD+ significantly increased the ICD algorithm diagnostic specificity and NPV for AF in the slow VT zone without compromising patient safety.

Arrhythmia detection by dual-chamber implantable cardioverter defibrillators. A review of current algorithms.

This article reviews the arrhythmia detection criteria currently available in dual-chamber implantable cardioverter defibrillators (ICDs), and describes the implementation and performance of various detection algorithms. Nearly all criteria implemented in single-chamber devices appear to have been included in dual-chamber ICDs. However, two different strategies can be distinguished: the first adds dual-chamber inhibition criteria to a single-chamber detection configuration; the second is a new approach entirely based on a dual-chamber detection scheme. Despite widely available clinical data, an analysis of the implemented detection indexes, arrhythmia characteristics (induced vs spontaneous, minimum duration), device programming (detection rate, programme maintenance and tuning during follow-up), and different storage capabilities among various ICD models, leaves the results of these studies ultimately ambiguous. New algorithms are under study, but only protocols using a single set of arrhythmias and the same programming for all devices may allow relevant comparisons of the performances of detection algorithms. Furthermore, a criterion is required to distinguish reliably between haemodynamically stable and unstable tachycardias, not simply based on rate, but including the underlying cardiac function.