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.

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.

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.

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.

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.

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.

Detection of acute myocardial ischemia during percutaneous transluminal coronary angioplasty by endocardial acceleration.

The first heart sound is generated by vibrations from the myocardium during isovolumic contraction. Peak endocardial acceleration (PEA) has been used previously to measure these vibrations in humans and correlates with myocardial contractility during inotropic interventions. It is unknown if changes in PEA can be used to characterize a reduction in contractility during ischemic episodes. This study was designed to evaluate the use of an endocardial accelerometer for the detection of acute myocardial ischemia. Thirteen patients undergoing routine percutaneous transluminal coronary angioplasty (PTCA) consented to having a single-axis, lead-based accelerometer positioned in the right ventricular apex. PEA was defined as the maximum peak-to-peak amplitude during a window 50 ms before to 200 ms following the peak R wave. Time of endocardial acceleration (TEA) was defined as the time from the peak R wave to the maximum accelerometer signal within this window. To obtain a more robust estimate of the strength of vibrations, a 100-beat template of the accelerometer signal was constructed at baseline and applied as a matched filter during ischemia. The peak magnitude of the filtered endocardial accelerometer signal (Max Filtered EA) was used as an index of signal intensity. Median baseline PEA, TEA, and Max Filtered EA were 0.91 +/- 0.35 g, 75.2 +/- 16.2 ms, and 0.40 +/- 0.20 g, respectively. PEA and Max Filtered EA significantly decreased by 7% during ischemia (0.91 to 0.85 g and 0.40 to 0.37 g, both P < 0.05, respectively). TEA did not significantly change from baseline (77.0 ms, P = ns). The results of this study suggest that acute ischemia can be detected with an endocardial accelerometer in humans.