Impact of pacing mode and different echocardiographic parameters on cardiac output (PADIAC).

Introduction: The extent of the hemodynamic benefit from AV-synchronous pacing in patients with sinus rhythm and AV block is not completely understood. Thus, we systematically investigated the association of an array of echocardiographic and epidemiological parameters with the change in cardiac output depending on the stimulation mode (AV-synchronous or AV-asynchronous pacing). Methods: Patients in sinus rhythm after previous dual chamber pacemaker implantation underwent a thorough basic echocardiographic assessment of diastolic and systolic left ventricular function, and atrial function (26 echo parameters, including novel speckle tracking strain measurements). Then, stroke volume was measured with AV-synchronous (DDD) and AV-asynchronous (VVI) pacing. Each patient represented their own control, and the sequence of stroke volume measurements was randomized. Results: In this prospective single-center study (NCT04068233, registration August 22nd 2019), we recruited 40 individuals. The stroke volume was higher in all patients when applying AV-synchronous DDD pacing [median increase 12.8 ml (16.9%), P < 0.001]. No echo parameter under investigation was associated with the extent of stroke volume increase in a linear regression model. Of all epidemiological variables, a history of acute myocardial infarction (AMI) was associated with an attenuated stroke volume gain in a univariate and a multivariate regression model that adjusted for confounders. A- and S-wave velocities were reduced in the AMI group. Discussion: In our cohort of patients, each subject benefited from AV-synchronous DDD pacing. No single echo parameter could predict the amount of stroke volume increase. The beneficial effect of AV-synchronous pacing on stroke volume was attenuated after prior acute myocardial infarction.ClinicalTrials.gov identifier (NCT number): NCT04068233.

Correlation between AV synchrony and device collected AM-VP sequence counter in atrioventricular synchronous leadless pacemakers: A real-world assessment.

INTRODUCTION: Micra atrioventricular (AV) provides leadless atrioventricular synchronous pacing by sensing atrial contraction (A4 signal). Real-world operation and reliability of AV synchrony (AVS) assessment using device data have not been described. The purposes of this study were to (1) assess the correlation between AVS and atrial mechanical sensed-ventricular pacing (AM-VP) percentages in patients with permanent high-degree AV block and (2) report on the real-world effectiveness of Micra AV. METHODS: The correlation between ECG-determined AVS in-clinic and device-collected %AM-VP was assessed using data from 40 patients with high-degree AV block enrolled in the Micra Atrial tRacking using a Ventricular AccELerometer (MARVEL) 2 study. A retrospective analysis to assess continuously-sampled %AM-VP since last session, device programming, and electrical parameters was performed using Micra AV transmissions from the Medtronic CareLink database. Patients with transmissions ≥180 days postimplant were included. RESULTS: Among the 40 MARVEL 2 AV block patients with a median %VP of 99.7%, AVS was highly correlated with AM-VP (median AVS 87.1%, median AM-VP 79.1%; R2 = 0.764, p < .001). The CareLink cohort included 4384 patients programmed to VDD mode. The mean A4 amplitude was 2.3 ± 1.8 m/s2 at implant and 2.3 ± 1.6 m/s2 at 28 weeks. In patients with %VP >90% (n = 1662), the median %AM-VP was 74.7%. For the full cohort, median %VP was 65.6% and median projected battery longevity was 10.5 years. CONCLUSION: In patients with a high pacing burden, %AM-VP provides a reasonable estimation of AVS. The first large real-world analysis of Micra AV patients with >90% VP showed stable atrial sensing over time with a median %AM-VP, a correlate of AVS, of 74.7%.

Ambulatory atrioventricular synchronous pacing over time using a leadless ventricular pacemaker: Primary results from the AccelAV study.

BACKGROUND: Previous studies demonstrated that accelerometer-based, mechanically timed atrioventricular synchrony (AVS) is feasible using a leadless ventricular pacemaker. OBJECTIVE: The purpose of this study was to determine the performance of a leadless ventricular pacemaker with accelerometer-based algorithms that provide AVS pacing. METHODS: AccelAV was a prospective, single-arm study to characterize AVS in patients implanted with a Micra AV, which uses the device accelerometer to mechanically detect atrial contractions and promote VDD pacing. The primary objective was to characterize resting AVS at 1 month in patients with complete atrioventricular block (AVB) and normal sinus function. RESULTS: A total of 152 patients (age 77 ± 11 years; 48% female) from 20 centers were enrolled and implanted with a leadless pacemaker. Among patients with normal sinus function and complete AVB (n = 54), mean resting AVS was 85.4% at 1 month, and ambulatory AVS was 74.8%. In the subset of patients (n = 20) with programming optimization, mean ambulatory AVS was 82.6%, representing a 10.5% improvement (P <.001). Quality of life as measured by the EQ-5D-3L (EuroQol Five-Dimensions Three-Level questionnaire) improved significantly from preimplant to 3 months (P = .031). In 37 patients with AVB at both 1 and 3 months, mean AVS during rest did not differ (86.1% vs 84.1%; P = .43). There were no upgrades to dual-chamber devices or cardiac resynchronization therapy through 3 months. CONCLUSION: Accelerometer-based mechanical atrial sensing provided by a leadless pacemaker implanted in the right ventricle significantly improves quality of life in a select cohort of patients with AV block and normal sinus function. AVS remained stable through 3 months, and there were no system upgrades to dual-chamber pacemakers.

Behavior of AV synchrony pacing mode in a leadless pacemaker during variable AV conduction and arrhythmias.

INTRODUCTION: MARVEL 2 assessed the efficacy of mechanical atrial sensing by a ventricular leadless pacemaker, enabling a VDD pacing mode. The behavior of the enhanced MARVEL 2 algorithm during variable atrio-ventricular conduction (AVC) and/or arrhythmias has not been characterized and is the focus of this study. METHODS: Of the 75 patients enrolled in the MARVEL 2 study, 73 had a rhythm assessment and were included in the analysis. The enhanced MARVEL 2 algorithm included a mode-switching algorithm that automatically switches between VDD and ventricular only antibradycardia pacing (VVI)-40 depending upon AVC status. RESULTS: Forty-two patients (58%) had persistent third degree AV block (AVB), 18 (25%) had 1:1 AVC, 5 (7%) had variable AVC status, and 8 (11%) had atrial arrhythmias. Among the 42 patients with persistent third degree AVB, the median ventricular pacing (VP) percentage was 99.9% compared to 0.2% among those with 1:1 AVC. As AVC status changed, the algorithm switched to VDD when the ventricular rate dropped less than 40 bpm. During atrial fibrillation (AF) with ventricular response greater than 40 bpm, VVI-40 mode was maintained. No pauses longer than 1500 ms were observed. Frequent ventricular premature beats reduced the percentage of AV synchrony. During AF, the atrial signal was of low amplitude and there was infrequent sensing. CONCLUSION: The mode switching algorithm reduced VP in patients with 1:1 AVC and appropriately switched to VDD during AV block. No pacing safety issues were observed during arrhythmias.

Predictors of atrial mechanical sensing and atrioventricular synchrony with a leadless ventricular pacemaker: Results from the MARVEL 2 Study.

BACKGROUND: The MARVEL (Micra Atrial TRacking Using a Ventricular AccELerometer) 2 study assessed the efficacy of atrioventricular (AV) synchronous pacing with a Micra leadless pacemaker. Average atrioventricular synchrony (AVS) was 89.2%. Previously, low amplitude of the Micra-sensed atrial signal (A4) was observed to be a factor of low AVS. OBJECTIVE: The purpose of this study was to identify predictors of A4 amplitude and high AVS. METHODS: We analyzed 64 patients enrolled in MARVEL 2 who had visible P waves on electrocardiogram for assessing A4 amplitude and 40 patients with third-degree AV block for assessing AVS at rest. High AVS was defined as >90% correct atrial-triggered ventricular pacing. The association between clinical factors and echocardiographic parameters with A4 amplitude was investigated using a multivariable model with lasso variable selection. Variables associated with A4 amplitude together with premature ventricular contraction burden, sinus rate, and sinus rate variability (standard deviation of successive differences of P-P intervals [SDSD]) were assessed for association with AVS. RESULTS: In univariate analysis, low A4 amplitude was inversely related to atrial function assessed by E/A ratio and e'/a' ratio, and was directly related to atrial contraction excursion (ACE) and atrial strain (Ɛa) on echocardiography (all P ≤.05). The multivariable lasso regression model found coronary artery bypass graft history, E/A ratio, ACE, and Ɛa were associated with low A4 amplitude. E/A ratio and SDSD were multivariable predictors of high AVS, with >90% probability if E/A <0.94 and SDSD <5 bpm. CONCLUSION: Clinical parameters and echocardiographic markers of atrial function are associated with A4 signal amplitude. High AVS can be predicted by E/A ratio <0.94 and low sinus rate variability at rest.

Atrioventricular Synchronous Pacing Using a Leadless Ventricular Pacemaker: Results From the MARVEL 2 Study.

OBJECTIVES: This study reports on the performance of a leadless ventricular pacemaker with automated, enhanced accelerometer-based algorithms that provide atrioventricular (AV) synchronous pacing. BACKGROUND: Despite many advantages, leadless pacemakers are currently only capable of single-chamber ventricular pacing. METHODS: The prospective MARVEL 2 (Micra Atrial tRacking using a Ventricular accELerometer 2) study assessed the performance of an automated, enhanced accelerometer-based algorithm downloaded to the Micra leadless pacemaker for up to 5 h in patients with AV block. The primary efficacy objective was to demonstrate the superiority of the algorithm to provide AV synchronous (VDD) pacing versus VVI-50 pacing in patients with sinus rhythm and complete AV block. The primary safety objective was to demonstrate that the algorithm did not result in pauses or heart rates of >100 beats/min. RESULTS: Overall, 75 patients from 12 centers were enrolled; an accelerometer-based algorithm was downloaded to their leadless pacemakers. Among the 40 patients with sinus rhythm and complete AV block included in the primary efficacy objective analysis, the proportion of patients with ≥70% AV synchrony at rest was significantly greater with VDD pacing than with VVI pacing (95% vs. 0%; p < 0.001). The mean percentage of AV synchrony increased from 26.8% (median: 26.9%) during VVI pacing to 89.2% (median: 94.3%) during VDD pacing. There were no pauses or episodes of oversensing-induced tachycardia reported during VDD pacing in all 75 patients. CONCLUSIONS: Accelerometer-based atrial sensing with an automated, enhanced algorithm significantly improved AV synchrony in patients with sinus rhythm and AV block who were implanted with a leadless ventricular pacemaker. (Micra Atrial Tracking Using a Ventricular Accelerometer 2 [MARVEL 2]; NCT03752151).

Novel Method for Assessment of His Bundle Pacing Morphology Using Near Field and Far Field Device Electrograms.

BACKGROUND: The 12-lead ECG is considered the gold standard to differentiate between selective (S), nonselective (NS) His bundle pacing (HBP), and right ventricular septal capture in routine clinical practice. We sought to assess the utility of device EGM recordings as a tool to identify the type of HBP morphology. METHODS: One hundred forty-eight consecutive patients underwent HBP with a 3830 Select Secure lead (Medtronic, Inc) at 3 centers between October 2016 and October 2017. The near field V-EGM morphology (NF EGM), near field V-EGM time to peak (NFTime to peak), and far-field EGM QRS duration (QRSd) were recorded while pacing the His lead with simultaneous 12-lead ECG rhythm strips. RESULTS: Indications for HBP were sinus node dysfunction, atrioventricular conduction disease, and cardiac resynchronization therapy in 68 (46%), 56 (38%), and 24 (16%) patients, respectively. Baseline QRSd was 108±38 ms with QRSd >120 ms in 57 (39%) patients (27 right bundle branch block, 18 left bundle branch block, and 12 intraventricular conduction delay). S-HBP was noted in 54 (36%) patients. A positive NFEGM and NFTime to peak >40 ms were highly sensitive (94% and 93%, respectively) and specific (90% and 94%) for S-HBP irrespective of baseline QRSd. All 3 parameters (+NFEGM, NFTime to peak >40 ms, and far-field EGM QRSd <120 ms) had high negative predictive value (97%, 95%, and 92%). A novel device-based algorithm for S-HBP was proposed. EGM transitions correlated with ECG transitions during threshold testing and can help accurately differentiate between S-HBP, NS-HBP, and right ventricular septal pacing with a cumulative positive predictive value of 91% (positive predictive value =100% in patients with baseline QRSd <120 ms). CONCLUSIONS: We propose a novel and simple criteria for accurate differentiation between S-HBP, NS-HBP, and right ventricular septal capture morphologies by careful analysis of device EGMs alone. This study paves the way for future studies to assess autocapture algorithms for devices with HBP.

Behavior of leadless AV synchronous pacing during atrial arrhythmias and stability of the atrial signals over time-Results of the MARVEL Evolve subanalysis.

INTRODUCTION: The MARVEL study demonstrated at a single time point that accelerometer (ACC)-based atrial sensing improves atrioventricular (AV) synchrony (AVS) in patients with AV block and a Micra pacemaker (Medtronic, Minneapolis, MN, USA). The purpose of the MARVEL Evolve substudy was to assess the performance over time. METHODS: This prospective single-center study compared AVS and ACC signals at two visits ≥6 months apart. Custom software was temporarily downloaded into the Micra at each visit and AVS was measured during 30 min at rest. RESULTS: Nine patients from the MARVEL study were enrolled. The mean (±standard deviation) age was 82.3 ± 6.0 years old, 67% were male, and a Micra was implanted for 6.0 ± 6.4 months. High-degree AV block was present in four patients, whereas five with predominantly intrinsic conduction required intermittent pacing for bradycardia. The mean interval between visits was 7.1 ± 0.6 months. Seven patients had normal sinus node function at both visits and were included in a paired analysis. Both ACC signal amplitude (visit 2-visit 1 = 1.4 mG; 95% confidence interval [CI] [-25.8 to 28.4 mG]; P = 0.933) and AVS (visit 1: 90.8%, 95% CI [72.4, 97.4] and visit 2: 91.4%, 95% CI [63.8, 98.5]; P = 0.740) remained stable. Three patients had spontaneous atrial tachycardia. During atrial fibrillation, no atrial contraction was detected or tracked. During atrial flutter, intermittent tracking resulted in a ventricular rate of 60 ± 8 beats per minute (bpm); there was no ventricular pacing >100 bpm. CONCLUSION: ACC signals amplitude and performance of AVS pacing were stable over time. During atrial arrhythmias, the AV synchronous pacing mode behaved safely.

Physical activity detection in patients with intracardiac leadless pacemaker.

INTRODUCTION: The Micra Transcatheter Pacing System provides a rate adaptive pacing using an individually programmable three-axis accelerometer. We evaluated the short- and mid-term performance of the Micra activity sensor by testing all three available activity vectors during the exercise tests. METHODS AND RESULTS: Implantation and follow-up data were prospectively collected from the patients undergoing Micra implantation at our institution. Patients underwent a 5-minute exercise test for each vector at predischarge (initial testing) and at scheduled in-office visits (repeat testing). On the basis of measurements of activity counts during the test, vectors were categorized to be adequate (excellent or acceptable) or poor. A total of 278 tests with 818 vector measurements were analyzed in 51 patients during follow-up (median duration was 18 months). Initial testing revealed the adequate quality of the nominal Vector 1 in 74.5% of the patients. Upon repeated testing at subsequent in-office visits, Vectors 1 and 3 were comparable (adequate quality in 64.7% vs 68.6% of the patients; P = 0.65) but better compared with Vector 2 (51.0%; P = 0.10 vs Vector 1, P = 0.01 vs Vector 3). In a subgroup of 45 patients programmed to VVIR mode, Vector 1 was selected in 46.7% of the patients after the initial test (Vector 2, 8.9%; Vector 3, 44.4%). Vector change was performed in 10 patients (22.2%) following repeated tests within 3 months of postimplantation. CONCLUSION: The three-axis accelerometer-based rate adaptive pacing feature proved to be feasible after manual selection of an adequate activity vector. Vector testing in Micra patients with chronotropic incompetence appears to be beneficial compared with the use of nominal Vector 1.

Accelerometer-based atrioventricular synchronous pacing with a ventricular leadless pacemaker: Results from the Micra atrioventricular feasibility studies.

BACKGROUND: Micra is a leadless pacemaker that is implanted in the right ventricle and provides rate response via a 3-axis accelerometer (ACC). Custom software was developed to detect atrial contraction using the ACC enabling atrioventricular (AV) synchronous pacing. OBJECTIVE: The purpose of this study was to sense atrial contractions from the Micra ACC signal and provide AV synchronous pacing. METHODS: The Micra Accelerometer Sensor Sub-Study (MASS) and MASS2 early feasibility studies showed intracardiac accelerations related to atrial contraction can be measured via ACC in the Micra leadless pacemaker. The Micra Atrial TRacking Using A Ventricular AccELerometer (MARVEL) study was a prospective multicenter study designed to characterize the closed-loop performance of an AV synchronous algorithm downloaded into previously implanted Micra devices. Atrioventricular synchrony (AVS) was measured during 30 minutes of rest and during VVI pacing. AVS was defined as a P wave visible on surface ECG followed by a ventricular event <300 ms. RESULTS: A total of 64 patients completed the MARVEL study procedure at 12 centers in 9 countries. Patients were implanted with a Micra for a median of 6.0 months (range 0-41.4). High-degree AV block was present in 33 patients, whereas 31 had predominantly intrinsic conduction during the study. Average AVS during AV algorithm pacing was 87.0% (95% confidence interval 81.8%-90.9%), 80.0% in high-degree block patients and 94.4% in patients with intrinsic conduction. AVS was significantly greater (P <.001) during AV algorithm pacing compared to VVI in high-degree block patients, whereas AVS was maintained in patients with intrinsic conduction. CONCLUSION: Accelerometer-based atrial sensing is feasible and significantly improves AVS in patients with AV block and a single-chamber leadless pacemaker implanted in the right ventricle.

Rate adaptive pacing in an intracardiac pacemaker.

BACKGROUND: The Micra transcatheter pacemaker was designed to have similar functionality to conventional transvenous VVIR pacing systems. It provides rate adaptive pacing using a programmable 3-axis accelerometer designed to detect patient activity in the presence of cardiac motion. OBJECTIVE: The purpose of this study was to evaluate the system's performance during treadmill tests to maximum exertion in a subset of patients within the Micra Transcatheter Pacing Study. METHODS: Patients underwent treadmill testing at 3 or 6 months postimplant with algorithm programming at physician discretion. Normalized sensor rate (SenR) relative to the programmed upper sensor rate was modeled as a function of normalized workload in metabolic equivalents (METS) relative to maximum METS achieved during the test. A normalized METS and SenR were determined at the end of each 1-minute treadmill stage. The proportionality of SenR to workload was evaluated by comparing the slope from this relationship to the prospectively defined tolerance margin (0.65-1.35). RESULTS: A total of 69 treadmill tests were attempted by 42 patients at 3 and 6 months postimplant. Thirty tests from 20 patients who completed ≥4 stages with an average slope of 0.86 (90% confidence interval 0.77-0.96) confirmed proportionality to workload. On an individual test basis, 25 of 30 point estimates (83.3%) had a normalized slope within the defined tolerance range (range 0.46-1.08). CONCLUSION: Accelerometer-based rate adaptive pacing was proportional to workload, thus confirming rate adaptive pacing commensurate to workload is achievable with an entirely intracardiac pacing system.

Early Performance and Safety of the Micra Transcatheter Pacemaker in Pigs.

BACKGROUND: The Micra® Transcatheter Pacing System (TPS; Medtronic Inc., Minneapolis, MN, USA) is a miniaturized single-chamber pacemaker system that is delivered via catheter through the femoral vein. In this study, the electrical performance was compared between the TPS and a traditional leaded pacemaker. In addition, the safety profile of the two systems was compared by thorough monitoring for a number of adverse events. METHODS: The TPS was implanted in the right ventricular apex of 10 Yucatan mini pigs and a Medtronic single-lead pacemaker (SLP) was implanted in the right ventricular apex of another 10 pigs and connected to a traditional pacemaker. The electrical performance of all devices was monitored for 12 weeks. The safety profile of each system was characterized using x-ray, computed tomography, ultrasound, blood work, and necropsy to monitor for a variety of adverse events. RESULTS: At implant the mean pacing thresholds were 0.58 ± 0.17 V @0.24 ms and 0.75 ± 0.29 V @0.21 ms for the TPS and the SLP respectively. After 12 weeks, mean thresholds were 0.94 ± 0.46 V and 1.85 ± 0.75 V (P < 0.0001). There were two pulmonary emboli that were small and past the tertiary branch, and one occurred in each arm. There were also two infections with one in each arm. There were no dislodgements (macro or micro), tissue injury, tamponade, or valve injury. CONCLUSIONS: Overall, despite the 10-fold size reduction of the Micra TPS, it appears to perform similarly and have a similar safety profile to a traditional pacemaker system.

Early performance of a miniaturized leadless cardiac pacemaker: the Micra Transcatheter Pacing Study.

AIMS: Permanent cardiac pacing is the only effective treatment for symptomatic bradycardia, but complications associated with conventional transvenous pacing systems are commonly related to the pacing lead and pocket. We describe the early performance of a novel self-contained miniaturized pacemaker. METHODS AND RESULTS: Patients having Class I or II indication for VVI pacing underwent implantation of a Micra transcatheter pacing system, from the femoral vein and fixated in the right ventricle using four protractible nitinol tines. Prespecified objectives were >85% freedom from unanticipated serious adverse device events (safety) and <2 V 3-month mean pacing capture threshold at 0.24 ms pulse width (efficacy). Patients were implanted (n = 140) from 23 centres in 11 countries (61% male, age 77.0 ± 10.2 years) for atrioventricular block (66%) or sinus node dysfunction (29%) indications. During mean follow-up of 1.9 ± 1.8 months, the safety endpoint was met with no unanticipated serious adverse device events. Thirty adverse events related to the system or procedure occurred, mostly due to transient dysrhythmias or femoral access complications. One pericardial effusion without tamponade occurred after 18 device deployments. In 60 patients followed to 3 months, mean pacing threshold was 0.51 ± 0.22 V, and no threshold was ≥2 V, meeting the efficacy endpoint (P < 0.001). Average R-wave was 16.1 ± 5.2 mV and impedance was 650.7 ± 130 ohms. CONCLUSION: Early assessment shows the transcatheter pacemaker can safely and effectively be applied. Long-term safety and benefit of the pacemaker will further be evaluated in the trial. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov ID NCT02004873.

His-bundle pacing versus biventricular pacing in cardiac resynchronization therapy patients: A crossover design comparison.

BACKGROUND: Cardiac resynchronization therapy (CRT) typically is attempted with biventricular pacing (BiVP). One-third of patients are nonresponders. His-bundle pacing (HBP) has been evaluated as an alternative means of effecting CRT because it generates truly physiologic ventricular activation, as evidenced in part by the morphologic identity between normally conducted and paced QRS complexes. OBJECTIVE: The purpose of this study was to assess the feasibility of, and clinical response to, permanent HBP as an alternative to BiVP in CRT-indicated patients. METHODS: Patients were implanted with a right atrial pacing lead, defibrillation lead, left ventricular (LV) lead via the coronary sinus, and HBP lead. His and LV leads were plugged into the LV port via a Y-adapter. After successful implant, patients were randomized in single patient-blinded fashion to either HBP or BiVP. After 6 months, patients were crossed over to the other pacing modality and followed for another 6 months. Quality-of-life assessments, echocardiographic measurements, New York Heart Association classification, and 6-minute hall walk test were obtained at baseline and at each 6-month follow-up. RESULTS: Twenty-nine patients were enrolled; 21 (72%) demonstrated electrical resynchronization (QRS narrowing) at implant. Twelve patients completed the crossover analysis at 1 year. Clinical outcomes (quality of life, New York Heart Association functional class, 6-minute hall walk test, LV ejection fraction) were significantly improved for both pacing modes compared with baseline measures. CONCLUSION: In this crossover comparison between HBP and BiVP, HBP was found to effect an equivalent CRT response. QRS narrowing was observed in 21 of 29 patients, suggesting this approach may be feasible in more patients with left bundle branch block than previously assumed.

The influence of atrial and ventricular pacing on the incidence of atrial fibrillation: a meta-analysis.

BACKGROUND: The effect of atrial pacing on the incidence of atrial fibrillation (AF) is unknown. Furthermore, the threshold of ventricular pacing that is associated with a higher incidence of AF has yet to be determined. Thus, we set out to determine the optimal pacing modality in patients with sinus node dysfunction (SND) for the prevention of AF. METHODS: Individual patient data from four contemporary pacemaker studies were gathered and analyzed. Since AF would inherently lead to a reduction in atrial pacing, percent atrial and ventricular pacing (%AP and %VP) were determined at the first follow-up visit and then used as a surrogate for all endpoints. Patients with >5 minutes of AF at the first visit were excluded. The primary endpoint was defined as 7 consecutive days of AF. RESULTS: A total of 1,507 patients were included. During a mean follow-up of 14.3 ± 8.7 months, 77 patients developed AF (annual rate of 4.3%). The incidence of AF in the first (0-32%), second (32-66%), third (66-89%), and fourth (89-100%) quartiles of %AP was 1.3%, 5.3%, 5.8%, and 8.0%, respectively (P < 0.001). A multivariable analysis found that pacing above the first quartile was associated with a relative risk of 2.93 (95% confidence interval 1.16-7.39, P = 0.023). The grouping of %VP into first (0-2%), second (2-7%), third (7-84%), and fourth (84-100%) quartiles yielded an AF incidence of 2.4%, 3.4%, 6.6%, and 8.0%, respectively (P = 0.001). CONCLUSION: We demonstrated that in patients with SND both atrial and ventricular pacing are associated with a higher incidence of AF.

Atrial pacing or ventricular backup-only pacing in implantable cardioverter-defibrillator patients.

BACKGROUND: The need for pacing support in typical ICD patients is unknown. OBJECTIVE: This study sought to determine whether atrial pacing with ventricular backup pacing is equivalent to ventricular backup pacing only in implantable cardioverter-defibrillator (ICD) patients. METHODS: We randomized 1,030 patients from 84 sites with indications for ICDs, with sinus rhythm, and without symptomatic bradycardia to atrial pacing with ventricular backup at 60 beats/min (518) or ventricular backup pacing at 40 beats/min (512). The primary end points were time to death, heart failure hospitalization (HFH), and heart failure-related urgent care (HFUC). RESULTS: Follow-up was 2.4 ± 0.8 years when the trial was stopped for futility. There were 355 end point events (103 deaths, 252 HFH/HFUC) in 194 patients favoring ventricular backup pacing (event-free rate 77.7% vs. 80.3% for atrial pacing at 30 months; hazard ratio 1.14, upper confidence bound 1.59, prespecified noninferiority threshold 1.21), therefore equivalence between pacing arms was not demonstrated. Overall HFH/HFUC rates were slightly higher during atrial pacing (event-free rate 85.4% vs. 86.4% for ventricular backup pacing). Exploratory analyses revealed that the difference in HFH/HFUC rates was largely seen in patients with a PR interval ≥230 ms. There were no differences between groups for atrial fibrillation, ventricular tachycardia/ventricular fibrillation, quality of life, or echocardiographic measurements. Fewer patients in the atrial pacing group were reported to develop an indication for bradycardia pacing (3.7% vs. 7.3%, P = .0053). CONCLUSION: Equivalence between atrial pacing and ventricular backup pacing only could not be demonstrated. CLINICAL TRIALS IDENTIFIER: NCT00281099.

Factors influencing pacemaker generator longevity: results from the complete automatic pacing threshold utilization recorded in the CAPTURE Trial.

OBJECTIVES: The CAPTURE study evaluated the accuracy of automated atrial and right ventricular (RV) threshold algorithms. BACKGROUND: Modern pacemakers include many added features designed to improve the ease of patient follow-up, as well as algorithms to reduce pacing outputs and/or reduce the atrial or ventricular pacing percentages, thus improving longevity. METHODS: Automated atrial and RV threshold measurements were assessed versus manual measurements at 6 months. The projected longevity was assessed and compared between subjects with the threshold-tracking feature On versus Off. In addition, the projected longevity effect of device features to reduce atrial pacing and reduce ventricular pacing, and device characteristics such as battery size and high impedance leads (> or =1,000 ohms), was investigated. RESULTS: Atrial and RV manual versus automatic measurements were equivalent in 683 of 691 subjects (98.8%) and 736 of 746 subjects (98.7%), respectively. Thresholds were stable with 99.6% of atrial and 99.2% of RV consecutive measurements within +/-0.25V. Algorithms for threshold tracking, reducing ventricular pacing, and reducing atrial pacing were associated with 0.8, 0.9, and 0.2 years projected longevity improvements. High impedance leads were associated with a 0.8-year projected longevity improvement. Approximately 2 years of longevity improvement was projected for a 1-cc increase in device size. CONCLUSIONS: The atrial and RV algorithms were accurate and reliable in all leads tested. Threshold tracking, reduced ventricular pacing, and high impedance leads result in increased device longevity. Battery capacity was the strongest determinant of increased projected longevity.

The effects of rate-adaptive atrial pacing versus ventricular backup pacing on exercise capacity in patients with left ventricular dysfunction.

BACKGROUND: Atrial rate-adaptive pacing may improve cardiopulmonary reserve in patients with left ventricular dysfunction. METHODS: A randomized, blinded, single-crossover design enrolled dual-chamber implantable defibrillator recipients without pacing indications and an ejection fraction < or =40% to undergo cardiopulmonary exercise treadmill stress testing in both atrial rate-adaptive pacing (AAIR) and ventricular demand pacing (VVI) pacing modes. The primary endpoint was change in peak oxygen consumption (VO(2)). Secondary endpoints were changes in anaerobic threshold, perceived exertion, exercise duration, and peak blood pressure. RESULTS: Ten patients, nine males, eight with New York Heart Association class I, mean ejection fraction 24 +/- 7%, were analyzed. Baseline VO(2) was 3.6 +/- 0.5 mL/kg/min. Heart rate at peak exercise was significantly higher during AAIR versus VVI pacing (142 +/- 18 vs 130 +/- 23 bpm; P = 0.05). However, there was no difference in peak VO(2) (AAIR 23.7 +/- 6.1 vs VVI 23.8 +/- 6.3 mL/kg/min; P = 0.8), anaerobic threshold (AAIR 1.3 +/- 0.3 vs VVI 1.2 +/- 0.2 L/min; P = 0.11), rate of perceived exertion (AAIR 7.3 +/- 1.5 vs VVI 7.8 +/- 1.2; P = 0.46), exercise duration (AAIR 15 minutes, 46 seconds +/- 2 minutes, 54 seconds vs VVI 16 minutes, 3 seconds +/- 2 minutes, 48 seconds; P = 0.38), or peak systolic blood pressure (AAIR 155 +/- 22 vs VVI 153 +/- 21; P = 0.61) between the two pacing modes. CONCLUSION: In this study, AAIR pacing did not improve peak VO(2,) anaerobic threshold, rate of perceived exertion, or exercise duration compared to VVI backup pacing in patients with left ventricular dysfunction and no pacing indications.

Severe atrioventricular decoupling, uncoupling, and ventriculoatrial coupling during enhanced atrial pacing: incidence, mechanisms, and implications for minimizing right ventricular pacing in ICD patients.

UNLABELLED: AV Decoupling During Enhanced AAIR Pacing. BACKGROUND: Enhanced AAI/R pacing minimizes right ventricular pacing but may permit or induce AV decoupling (AV-DC) due to unrestricted AV intervals (AVIs). The purpose of this study was to characterize and quantify AVI behavior in a randomized trial of enhanced AAI/R pacing in ICD patients. METHODS: One hundred twenty-one patients in the Marquis ICD MVPtrade mark Study, a randomized 1-month crossover comparison of cumulative% ventricular pacing (Cum%VP) in enhanced AAIR (MVP) vs DDD/R, were analyzed. AV-DC was defined as >or=40% AVIs >300 ms; VA coupling (VA-C) was defined as%V-atrial pace (AP) intervals <300 ms. Dynamic AVI behavior and increases in Cum%VP due to AV block (AV uncoupling, AV-UC) were characterized using Holters with real-time ICD telemetry. RESULTS: AV-DC occurred in 17 (14%) of patients. Baseline PR, amiodarone, nighttime, lower rate >60 beats/min, rate response, and Cum%AP were associated with longer AVIs. Logistic regression identified baseline PR (odds ratio [OR]= 1.024, 95% confidence interval [CI] 1.007-1.042; P = 0.005), and Cum%AP (OR = 1.089, 95% CI 1.027-1.154; P = 0.004) as predictors of AV-DC. AV-DC was associated with approximately 10-fold increases in both Cum%VP (13.6 +/- 28.3% vs 1.2 +/- 3.9%; P = 0.023) due to transient AV-UC) and VA-C (6.0 +/- 17.5% vs 0.5 +/- 1.2%, P = 0.028). AV coupling (<40% AVIs >300 ms) was preserved in 104 (86%) patients. CONCLUSIONS: AV-DC, VA-C, and AV-UC may be worsened or induced by enhanced AAI/R pacing. Conservative programming of lower rate and rate response should reduce the risk of AV-DC by reducing Cum%AP.