Patients' knowledge and attitudes regarding living with implantable electronic devices: results of a multicentre, multinational patient survey conducted by the European Heart Rhythm Association.

The purpose of this patient survey was to analyse the knowledge, experiences, and attitudes regarding cardiac implantable electronic devices (CIED) in patients with pacemakers, implantable cardioverter-defibrillators (ICDs), or cardiac resynchronization devices. Of the 1644 patients with CIEDs from seven European countries, 88% were over 50 years of age. Most patients (90%) knew what device they were implanted with and felt sufficiently informed about the indications for therapy. As many as 42% of patients needed additional information on the battery replacement and limitations in physical activity. The self-reported incidence of complications was 9%, and among these, a quarter of the respondents felt insufficiently informed about the possibility of complications and their management. The majority of patients (83%) were followed by face-to-face visits, which was the most commonly preferred follow-up strategy by the patients. Nearly 75% of the patients reported improved quality of life after device implantation, but about 40% had worries about their device. Less than 20% had discussed with their physician or thought about device handling in the end-of-life circumstances or end-stage disease. Notably, almost 20% of the ICD patients did not wish to answer the question regarding what they wanted to be done with their ICD in case of end-stage disease, indicating the challenges in approaching these issues.

Simultaneous His Bundle and Left Ventricular Pacing for Optimal Cardiac Resynchronization Therapy Delivery: Acute Hemodynamic Assessment by Pressure-Volume Loops.

BACKGROUND: Previous studies have investigated the role of intrinsic conduction in optimizing cardiac resynchronization therapy. We investigated the role of fusing pacing-induced activation and intrinsic conduction in cardiac resynchronization therapy by evaluating the acute hemodynamic effects of simultaneous His-bundle (HIS) and left ventricular (LV) pacing. METHODS AND RESULTS: We studied 11 patients with systolic heart failure and left bundle-branch block scheduled for cardiac resynchronization therapy implantation. On implantation, LV pressure-volume data were determined via conductance catheter. Standard leads were placed in the right atrium, at the right ventricular apex, and in a coronary vein. An additional electrode was temporarily positioned in the HIS. The following pacing configurations were systematically assessed: standard biventricular (right ventricular apex+LV), LV-only, HIS, simultaneous HIS and LV (HIS+LV). Each configuration was compared with the AAI mode at multiple atrioventricular delays (AVD). In comparison with the AAI, right ventricular apex+LV and LV-only pacing resulted in improved stroke volume (85±32 mL and 86±33 mL versus 58±23 mL; P<0.001), stroke work, maximum pressure derivative, and systolic dyssynchrony at individually optimized AVD. The optimal AVD was close to the P-H interval in the majority of patients. By contrast, HIS-LV pacing improved hemodynamic indexes at all AVD (stroke volume >76 mL at all fixed intervals and 88±31 mL at optimal interval; all P<0.001). CONCLUSIONS: Standard right ventricular apex+LV and LV-only pacing enhanced systolic function and LV synchrony at individually optimized AVD close to the measured intrinsic P-H interval. By contrast, HIS+LV pacing yielded improvements, regardless of AVD setting. These findings support the hypothesis of the crucial role of intrinsic right ventricular conduction in optimal cardiac resynchronization therapy delivery.

Assessment of Myocardial Contractility by SonR Sensor in Patients Undergoing Cardiac Resynchronization Therapy.

BACKGROUND: SonR sensor signal correlates well with myocardial contractility expressed in terms of left ventricular (LV) dP/dt max. The aim of our study was to evaluate the changes in myocardial contractility during isometric effort in heart failure patients undergoing cardiac resynchronization therapy (CRT) with right atrial SonR sensor. METHODS: Thirty-one patients (19 men, 65 ± 7 years, LV ejection fraction [LVEF] 28% ± 5%, in sinus rhythm) were implanted with a CRT-defibrillator (CRT-D) device equipped with SonR sensor, which was programmed in VVI mode at 40 beats/min. Twenty-four hours after implantation, each patient underwent a noninvasive hemodynamic evaluation at rest and during isometric effort, including: (1) measurement of beat-to-beat endocavitary SonR signal; (2) echocardiographic assessment; and (3) continuous measurement of blood pressure with Nexfin method (BMEYE, Amsterdam, the Netherlands). The following contractility parameters were considered: (1) mean value of beat-to-beat SonR signal; (2) mean value of LV dP/dt by Nexfin system; and (3) fractional shortening (FS) by echocardiography. RESULTS: At the third minute of the isometric effort, mean value of SonR signal significantly increased from baseline (P < 0.001). Similarly, mean value of both LV dP/dt by Nexfin and FS significantly increased compared to the resting condition (P < 0.001; P < 0.001). While in 27 (88%) patients SonR signal increased at the third minute of the isometric effort, in four (12%) patients SonR signal decreased. In these patients, both LV dP/dt by Nexfin and FS consensually decreased. CONCLUSIONS: In CRT patients, SonR sensor is able to detect changes in myocardial contractility in a consensual way like noninvasive methods such as Nexfin system and echocardiography.

Cardiac resynchronization therapy acutely improves ventricular-arterial coupling by reducing the arterial load: assessment by pressure-volume loops.

BACKGROUND: Cardiac resynchronization therapy (CRT) has been demonstrated to improve ventricular-arterial coupling by reducing effective arterial elastance (Ea) on long-term follow-up. Detailed invasive studies showing possible acute peripheral effects of CRT are not available. We evaluated the hemodynamic effects of CRT in patients with systolic dysfunction, in order to investigate the impact on ventricular-arterial coupling and, in particular, on Ea immediately after the initiation of pacing. METHODS: We studied 37 heart failure patients undergoing CRT implantation based on conventional criteria. On implantation, left ventricular (LV) pressure and volume data were determined via a conductance catheter. Twelve patients with a standard indication for electrophysiologic study and preserved LV function served as a control group. RESULTS: In comparison with the control group, heart failure patients showed reduced systolic and diastolic function. LV end-systolic elastance (Ees: end-systolic pressure/volume) was impaired (0.79 ± 0.33 mm Hg/mL vs 1.84 ± 0.89 mm Hg/mL, P = 0.012) and Ees/Ea reduced (0.36 ± 0.17 vs 1.19 ± 1.81, P = 0.022). In heart failure patients, CRT immediately improved systolic function, increasing stroke work from 3.9 ± 1.8 L*mm Hg to 6.9 ± 3.3 L*mm Hg (P < 0.001) and Ees to 1.02 ± 0.62 mm Hg/mL (P = 0.001). Ea decreased from 2.59 ± 1.35 mm Hg/mL to 1.68 ± 0.91 mm Hg/mL (P < 0.001), leading to an increase in Ees/Ea to 0.70 ± 0.38 (P < 0.001). CONCLUSION: Our data indicate that switching CRT on induces an immediate reduction in arterial load, conceivably as a consequence of restored autonomic balance.

Acute hemodynamic effect of left ventricular endocardial pacing in cardiac resynchronization therapy: assessment by pressure-volume loops.

BACKGROUND: During cardiac resynchronization therapy (CRT) device implantation, the pacing lead is usually positioned in the coronary sinus (CS) to stimulate the left ventricular (LV) epicardium. Transvenous LV endocardial pacing via transseptal puncture has been proposed as an alternative method. In the present study, we evaluated the acute hemodynamic effects of CRT through LV endocardial pacing in heart failure patients by analyzing LV pressure-volume relationships. METHODS AND RESULTS: LV pressure and volume data were determined via conductance catheter during CRT device implantation in 10 patients. In addition to the standard epicardial CS pacing, the following endocardial LV sites were systematically assessed: the site transmural to the CS lead, the LV apex, the septal midwall, the basal lateral free wall, and the midlateral free wall. Four atrioventricular delays were tested. There was a significant improvement of systolic function with CRT in all LV pacing configurations, whereas no differences in systolic or diastolic function were detected between LV epicardial and endocardial transmural sites. The optimal pacing site varied among patients but was rarely related to relatively longer activation delays, as assessed by analyzing endocardial electric activation maps. Nonetheless, positioning the pacing lead at the optimal endocardial LV site in each patient significantly improved LV performance in comparison with conventional CS site stimulation (stroke volume, 83 [79-112] mL versus 73 [62-89] mL; P=0.034). CONCLUSIONS: Pacing at the optimal individual LV endocardial site yields enhanced LV performance in comparison with conventional CS site stimulation. Endocardial LV pacing might constitute an alternative approach to CRT, when CS pacing is not viable.

Temporal variability of atrial tachyarrhythmia burden in bradycardia-tachycardia syndrome patients.

AIMS: Several studies have tested non-pharmacological therapies for atrial tachyarrhythmias (ATs) by measuring the cumulative time (burden) the patient spends in arrhythmia. Contradictory results questioned either therapy efficacy or statistical power of the trials. We studied AT burden variability in patients paced for sinus node disease (SND) in order to interpret currently published data appropriately and to evaluate reliable sample sizes. METHODS AND RESULTS: One hundred and five patients with AT and SND received a dual chamber pacemaker with antitachyarrhythmia-pacing capability, and were followed for 13 months. Seventy-eight patients (74%) suffered AT recurrences. Device-gathered diagnostic measures were used to simulate results of randomized studies both with crossover and parallel design. The sample size required for statistically significant results was calculated as a function of the expected therapy-induced burden reduction. AT burden intra-patient variability was high: 43% of patients showed intrinsic fluctuations hiding any therapy-induced burden reduction lower than 30%. Demonstrating therapeutic breakthrough through a 6 month study would require 290 patients with crossover design and 5800 patients with parallel design. Doubling the study period requires 400 and 3000 patients, respectively. CONCLUSION: Patients with AT and paced for SND showed high intra-patient burden variability, which could possibly hide an AT burden reduction induced by a therapy. Previous studies involving non-pharmacological therapies utilizing AT burden endpoints could lack the power to reach statistical significance.

P wave assessment: state of the art update.

Diagnostic (mapping) and therapeutic (ablation, pacing) advances have provided insight into atrial depolarization processes and new developments in P wave analysis. Information about interatrial pathways is important to the understanding of interatrial conduction delay. A standardized method for P wave analysis is necessary for the development of a clinical role for management of patients with paroxysmal atrial fibrillation using signal-averaged P wave analysis and P wave dispersion. Algorithms for predicting localization of ectopic P waves may facilitate catheter ablation. P wave changes due to pacing at different atrial sites may be useful for permanent pacing for prevention of atrial fibrillation. Introduction of these developments into clinical practice should allow better prevention and treatment of atrial arrhythmias and could have considerable impact in view of their high frequency especially in the older population.