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Aims: Implantable cardioverter defibrillators (ICDs) are used for primary or secondary prevention of sudden cardiac death. We sought to clarify prognosis and causes of death after ICD implantation., Methods and Results: A total of 2743 patients with ICDs implanted during 1990-2020 were analyzed. Median age was 68.5 (59.6-74.6) years; 21% women, median left ventricular ejection fraction (LVEF) was 30 (23-35), 52% had an ischemic etiology and 77% had a primary preventive indication. Mortality rate after 10 years was 22, 44, 55, and 72% in the 1st, 2nd, 3rd, and 4 th age quartile, respectively. The calculated median sex and age adjusted loss of life years compared to the average German population was 9.7 (6.1-14.0) years. Prognosis was independently related to sex, age, LVEF, and glomerular filtration rate. 713 out of 852 deaths could be classified to a specific cause. Congestive heart failure (CHF) accounted for death in 214 (30%) and sudden death (SD) for 144 patients (20%). Postmortem interrogation of devices in 74 patients revealed VT/VF in 39 and no episodes in 35 patients. Cancer was identified as the cause of death in 121 patients (17% of cases), of which 36 were bronchial carcinomas. 73 (10%) of patients died due to infection. 67 patients (9%) died within 24 h of procedures. Compared to other causes, significantly more life years were lost associated with procedures and SD: 9.3 (5.7-12.9) versus 12.1 (7.4-15.2) and 11.9 (7.6-17.8) years., Conclusion: Life expectancy of ICD patients is lower than for the general population. Mortality is predominantly due to CHF, but there is still a considerable rate of SD. The occurrence of cancers, most importantly bronchial carcinomas, and infections, warrants protective measures. Some deaths during procedures are possibly preventable. Patients with ICDs comprise a vulnerable cohort, and treatment has to be optimized in many directions to improve prognosis.

Background: A significant proportion of patients receiving CRT are non-responders. We evaluated the efficacy of Cardiac Contractility Modulation in subjects with reduced LVEF who, despite cardiac resynchronization therapy (CRT), continued to experience clinically significant symptoms., Methods: This was a multi-center, open label, treatment-only, feasibility study of 17 CRT non-responders who received CCM therapy. Changes in NYHA class, ejection fraction (EF), Minnesota Living with Heart Failure Questionnaire (MLWHFQ) score, and exercise tolerance (6 minute walk test; 6MWT and peak VO 2 ) were analyzed over 6 months. Mortality and hospitalization rates were determined., Results: Patients (82% male) were 69.4 ± 9.6 years of age with baseline EF = 22.8 ± 6.5%. Among primary endpoints, peak VO 2 increased 1.1 ± 1.6 ml/kg/min (p = 0.03) and MLWHFQ improved (-16 ± 16 points; p < 0.01). Mean NYHA class improved (-0.33 ± 0.49; p = 0.02), 6MWT increased (52 ± 60 m; p < 0.01), while EF trended up (2.9 ± 5.8%; p = 0.08) at 6 months. During the 6-month follow-up period, there were 18 hospitalizations in 9 subjects and 2 patients died., Conclusions: Patients with heart failure and reduced ejection fraction who remain moderately to severely symptomatic despite use of CRT, may benefit from CCM therapy with improvement in quality of life and exercise tolerance. A larger prospective study in this population is warranted., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Patients receiving dual-chamber implantable cardioverter-defibrillator (DR-ICD) therapy are at risk of developing atrial arrhythmia because of the increased rate of ventricular pacing and the progression of heart failure. Remote monitoring (RM) may identify the patients at highest risk of adverse events such as atrial arrhythmias. A total of 283 patients with 91,632 remote transmissions during a 15-month follow-up (FU) period enrolled in the LION registry were analysed. The parameters retrieved included the pacing mode, lower rate limit, percentage of atrial (%AP) and ventricular pacing (%VP), and percentage of atrial arrhythmia burden (%AB). In 92.7% of patients, the devices were initially programmed in DDD(R) or DDI(R), with changes of the pacing mode in 19.3% only. The lower rate limit remained stable in 80.4% of patients. At the first transmission, 8.7% of patients suffered from RM-detected atrial arrhythmia, which reached 36% during FU. The %AP was not associated with increased AB ( p = 0.67), but the %VP was different in patients developing RM-detected atrial arrhythmia (26.9% vs. 13.7%, p < 0.00001). The %VP increased in 105 patients (significance level of α = 0.05), and 11 patients crossed the border of 50% VP. The LION substudy supports the concept of using RM in a real-world DR-ICD population. Remote monitoring of DR-ICDs allows for the quantification of the course of the pacing parameters and AB. Based on these observations, device parameters can be adjusted and optimized.

Aims: One option to improve cardiac resynchronization therapy (CRT) responder rates lies in the optimization of pacing intervals. A haemodynamic sensor embedded in the SonRtip atrial lead measures cardiac contractility and provides a systematic automatic atrioventricular and interventricular delays optimization. This multi-centre study evaluated the safety and performance of the lead, up to 1 year., Methods and Results: A total of 99 patients were implanted with the system composed of the lead and a CRT-Defibrillator device. Patients were followed at 1, 3, 6, and 12 months post-implant. The primary safety objective was to demonstrate that the atrial lead complication free rate was superior to 90% at 3-months follow-up visit. A lead handling questionnaire was filled by implanting investigators. Lead electrical performances and the performance of the system to compute AV and VV delays were evaluated at each study visit over 1 year. The complication free rate at 3 months post-implant was 99.0% [95%CI 94.5-100.0%], P < 0.001. Electrical performances of the lead were adequate whatever the atrial lead position and remained stable over the study period. The optimization algorithm was able to compute AV and VV delays in 97% of patients, during >75% of the weeks., Conclusion: The atrial lead is safe to implant and shows stable electrical performance over time. It therefore offers a promising tool for automatic CRT optimization to further improve responder rates to CRT., (© The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Objective: Implantable cardioverter-defibrillators (ICDs) alone or combined with cardiac resynchronization therapy (CRT-Ds) featuring automatic home monitoring (HM) function can be monitored remotely on a daily basis. Different ways of implementing HM into clinical routines are possible, with efficient patient management being the main objective. In this study, a concept using a telemedical service center (TmSC) to manage HM data was developed and investigated regarding patients' satisfaction, physicians' satisfaction, and alert filtering., Subjects and Methods: Fifty-five ICD or CRT-D patients with symptomatic heart failure were enrolled. The TmSC received HM data, identified "actionable parameters" (APs) by following protocol-defined procedures, conducted structured patient interviews, and forwarded selected APs to the respective follow-up clinic. Satisfaction of patients and physicians with the TmSC was evaluated at the end of the study by purpose-designed questionnaires., Results: During a mean follow-up of 402±200 days, 3,831 APs were identified and analyzed at the TmSC (5.28 per patient-month). Most APs were triggered by a pilot detection algorithm for worsening heart failure (2.80 per patient-month), followed by atrial tachyarrhythmia episodes (1.10 per patient-month) and ventricular pacing issues (0.87 per patient-month). The TmSC forwarded 682 APs (18% of all APs) to 10 study sites. Approximately 65% of physicians and patients deemed the TmSC improved patient care., Conclusions: The TmSC-based management concept was well accepted and appreciated by the majority of physicians and patients. It may be helpful in gaining symptomatic information on top of automatic HM data and in supporting smaller clinics in the follow-up of their device patients.

Aim: To investigate whether diagnostic data from implanted cardiac resynchronization therapy defibrillators (CRT-Ds) retrieved automatically at 24 h intervals via a Home Monitoring function can enable dynamic prediction of cardiovascular hospitalization and death., Methods and Results: Three hundred and seventy-seven heart failure patients received CRT-Ds with Home Monitoring option. Data on all deaths and hospitalizations due to cardiovascular reasons and Home Monitoring data were collected prospectively during 1-year follow-up to develop a predictive algorithm with a predefined specificity of 99.5%. Seven parameters were included in the algorithm: mean heart rate over 24 h, heart rate at rest, patient activity, frequency of ventricular extrasystoles, atrial-atrial intervals (heart rate variability), right ventricular pacing impedance, and painless shock impedance. The algorithm was developed using a 25-day monitoring window ending 3 days before hospitalization or death. While the retrospective sensitivities of the individual parameters ranged from 23.6 to 50.0%, the combination of all parameters was 65.4% sensitive in detecting cardiovascular hospitalizations and deaths with 99.5% specificity (corresponding to 1.83 false-positive detections per patient-year of follow-up). The estimated relative risk of an event was 7.15-fold higher after a positive predictor finding than after a negative predictor finding., Conclusion: We developed an automated algorithm for dynamic prediction of cardiovascular events in patients treated with CRT-D devices capable of daily transmission of their diagnostic data via Home Monitoring. This tool may increase patients' quality of life and reduce morbidity, mortality, and health economic burden, it now warrants prospective studies. ClinicalTrials.gov  NCT00376116.

Cardiac resynchronization therapy (CRT) using coronary sinus (CS) leads is an established therapy for congestive heart failure in patients with asynchronous ventricular contractions. CRT improves not only exercise tolerance but also the patient's prognosis. Appropriate patient selection for CRT is essential for a successful therapeutic response. Inclusion criteria are based on symptoms (New York Heart Association classes III and IV), a reduced ejection fraction, and a widened QRS complex. The presence of objective markers of heart failure can be considered a prerequisite for successful CRT. CRT procedures are much longer than regular pacemaker implantations, and thus the risk of infection may be greater. Successful therapy depends on the placement of left ventricular leads, usually via the CS, which is a technically more challenging procedure than regular pacemaker implantations. Complications specific to CRT include ventricular arrhythmia, such as ventricular tachycardia or ventricular fibrillation; total atrioventricular block or sinus arrest without any escape rhythm; and CS dissection.

The authors wanted to investigate whether the heart failure survival score (HFSS) is useful for sudden cardiac arrest (SCA) risk stratification and whether there is a difference with regard to congestive heart failure (CHF) etiology. Data of 712 severe CHF patients (New York Heart Association III/IV 58%/42%, mean age 62+/-8 years, mean left ventricular ejection fraction 26%+/-11%) during the period from 1993-2003 were analyzed. The HFSS was calculated using the Aaronson formula. SCA-free survival was calculated using Kaplan-Meier analysis according to the etiology of CHF: coronary artery disease (CAD) (n=317) vs no CAD (n=395). In regard to SCA risk, the authors found no significant overall difference between patients with or without CAD. Non-CAD HFSS high-risk patients had a significantly higher risk for SCA than all the other groups ( P<.001). The HFSS is useful for the detection of a subgroup of non-CAD severe CHF patients at very high risk for SCA.

Aims: Chronotropic incompetence (CI) in patients with congestive heart failure (CHF) develops frequently under beta-blocker and amiodarone therapy. It can be corrected by pacing. We performed a randomized study to test whether pacing is beneficial in CHF patients with CI., Methods and Results: Congestive heart failure patients under combined beta-blocker and amiodarone therapy (n = 77) were randomly assigned to inhibited pacing (INH; basal rate 40 bpm/hysteresis 30 bpm; n = 38) or to DDDR pacing with optimized atrioventricular delay (OPT; stimulation rate 65-120 bpm, n = 39). Groups showed similar baseline values in NYHA class, heart rate, and ejection fraction (EF) and were followed up to 10 years. The resting and mean 24 h heart rate after 1 year decreased by -2.6/-5 bpm in INH, but increased by +3.6/+6.0 bpm in the OPT group (P < 0.001). The QRS interval after 1 year increased by 12 +/- 23 ms in the INH group, but +32 +/- 36 ms in the OPT group (P < 0.01). Patients with INH developed a greater left ventricular EF (LVEF) when compared with OPT patients (+10.6 +/- 8 vs. +2 +/- 10%, respectively; P = 0.04). Changes in LVEF were negatively correlated with heart rate, but not with QRS width changes. Prognosis and the event rate were better in the INH group., Conclusion: In the long-term follow-up, single-site ventricular pacing in patients with CHF and low LVEF is associated with significant clinical events and a poor prognosis.

Introduction: Left bundle brunch block (LBBB) and right ventricular stimulation (RVS) may be associated with asynchrony and heart failure. Differences between these two entities and their response to cardiac resynchronization therapy (CRT) are not well defined., Methods: Patients receiving CRT from 1999 to 2006 were analyzed for cardiac events and prognosis separated between primary implants for LBBB (n = 221) and upgrades from RVS (n = 107). A subgroup of 105 patients (LBBB = 69; RVS = 36) was studied in more detail (New York Heart Association [NYHA], quality of life, brain natriuretic peptide, peak VO2, left ventricular ejection fraction [LVEF], wedge pressure, Cardiac Index, QRS, left-right preejection period using pulsed wave doppler, septum-lateral wall motion delay using tissue doppler imaging) at baseline and after 1 year., Results: Age (68.4 +/- 11 years vs 68.7 +/- 15 years, n. s.), NYHA class (3.1 vs 3.1, n. s.), LVEF (26.4 vs 28.1, n. s.), and clinical parameters were comparable between LBBB and RVS. The latter group consisted of more patients with chronic atrial fibrillation (14% vs 37%, P = 0.03). After 1 year, NYHA class (-0.8 +/- 0.8 vs -0.6 +/- 0.8, n. s.), LVEF (+13.7 +/- 14% vs +8.7 +/- 10%, n. s.), and clinical parameters improved similarly. After a median follow-up of 2.33 +/- 1.8 years in the LBBB versus 2.43 +/- 1.9 years in the RVS group, there was no difference in long-term prognosis or cardiac events in the total cohort (5-year event rate, 53% vs 55%, P = n. s.)., Conclusion: Upgrade patients showed similar baseline parameters and response to CRT as to primary implants. No difference in events or long-term prognosis could be observed.

Aims: To evaluate the utility of intrathoracic impedance monitoring for detecting heart failure (HF) deterioration in patients with an implanted cardiac resynchronization/defibrillation device., Methods and Results: Patients enrolled in the European InSync Sentry Observational Study were audibly alerted by a device algorithm if a decrease in intrathoracic impedance suggested fluid accumulation. Clinical HF status and device data were assessed at enrolment, during regular follow-up, and if patients presented with an alert or HF deterioration. Data from 373 subjects were analysed. Fifty-three alert events and a total of 53 clinical events (HF deterioration defined by worsening of HF signs and symptoms) were reported during a median of 4.2 months. Adjusted for multiple events per patient, the alert detected clinical HF deterioration with 60% sensitivity (95% CI 46-73) and with a positive predictive value of 60% (95% CI 46-73). Higher NYHA class at baseline was predictive for adequate alert events during follow-up (P < 0.05). In 11 of 20 HF deteriorations without preceding alert, an upstroke of the fluid index occurred without reaching the programmed alert threshold., Conclusion: A device-based algorithm that alerts patients in case of decreasing intrathoracic impedance facilitates the detection of HF deterioration. Future randomized, controlled trials are needed to test whether the tailored use of intrathoracic impedance monitoring can improve the ambulatory management of patients with chronic HF and an implanted device.

Aims: One option to improve cardiac resynchronization therapy (CRT) responder rates lies in the optimization of pacing intervals. A haemodynamic sensor embedded in the SonRtip atrial lead measures cardiac contractility and provides a systematic automatic atrioventricular and interventricular delays optimization. This multi-centre study evaluated the safety and performance of the lead, up to 1 year.Methods and Results: A total of 99 patients were implanted with the system composed of the lead and a CRT-Defibrillator device. Patients were followed at 1, 3, 6, and 12 months post-implant. The primary safety objective was to demonstrate that the atrial lead complication free rate was superior to 90% at 3-months follow-up visit. A lead handling questionnaire was filled by implanting investigators. Lead electrical performances and the performance of the system to compute AV and VV delays were evaluated at each study visit over 1 year. The complication free rate at 3 months post-implant was 99.0% [95%CI 94.5-100.0%], P < 0.001. Electrical performances of the lead were adequate whatever the atrial lead position and remained stable over the study period. The optimization algorithm was able to compute AV and VV delays in 97% of patients, during >75% of the weeks.Conclusion: The atrial lead is safe to implant and shows stable electrical performance over time. It therefore offers a promising tool for automatic CRT optimization to further improve responder rates to CRT. [ABSTRACT FROM AUTHOR]

Abstract: Background: A novel method to estimate cardiac volumes based on impedance measurements using the leads of a resynchronization device has been developed. This study investigated the method in patients with ischemic cardiomyopathy and documented wall motion abnormalities. Method and Results: Fifteen postinfarction patients (age 68 ± 8 years, ejection fraction 27 ± 5%) with symptomatic heart failure and ≥1 akinetic or dyskinetic segment were included. During the implantation of a cardiac resynchronization therapy (CRT) device, acute impedance curves were recorded along with stroke volume determined by the arterial pulse contour method. In an overdrive protocol, the impedance parameter “stroke impedance” decreased in significant correlation with stroke volume in all patients. The median correlation coefficient between stroke volume and stroke impedance was 0.83 (interquartile range 0.70–0.89). Furthermore, the atrioventricular delay was optimized based on impedance and reference stroke volume. After optimization by the impedance method, it differed by 18 ± 15 ms from the figure after optimization by the invasive reference. Compared with a standard atrioventricular delay of 120 ms, stroke volume was improved by 8.6 ± 9.8% with the use of invasive optimization and by 6.4 ± 10.8% with the use of impedance-based optimization. Conclusions: In CRT patients with chronic infarction and wall motion abnormalities, impedance is a valid parameter to estimate stroke volume and to guide optimization of CRT timing. [Copyright &y& Elsevier]

Aims: Chronotropic incompetence (CI) in patients with congestive heart failure (CHF) develops frequently under β-blocker and amiodarone therapy. It can be corrected by pacing. We performed a randomized study to test whether pacing is beneficial in CHF patients with CI. [ABSTRACT FROM PUBLISHER]

Background: Carvedilol and at least in some studies, amiodarone have been shown to improve symptoms and prognosis of patients with heart failure. There are no reports on the outcome of combined treatment with both drugs on top of angiotensin-converting enzyme inhibitors (ACEI), diuretics and digitalis.Methods and Results: In 109 patients with severe heart failure submitted for heart transplantation at one single center between the years 1996 and 1998 [left ventricular ejection fraction (LVEF) 24.6+/-11%, 85% males, 52% idiopathic dilated cardiomyopathy (DCM), mean observation time 1. 9+/-0.4 years] a therapy with low-dose amiodarone (1000 mg/week) plus titrated doses of carvedilol (target 50 mg/day) was instituted. In addition, patients received a prophylactic dual chamber pacemaker (PM) in order to protect from bradycardia and for continuous holter monitoring. The devices were programmed in back-up mode with a basal rate of 40 i.p.m. with a hysteresis of 25%. Significantly, more patients were in sinus rhythm after 1 year than at study entry (85% vs. 63%, P<0.01). In 47 patients, under therapy over at least 1 year, the resting heart rate fell from 90+/-19 to 59+/-5 b.p.m. (P<0.001). Ventricular premature contractions in 24-h holter ECGs were suppressed from 1.0+/-3 to 0.1+/-0.3%/24 h (P167 b.p.m. detected by the pacemaker (1.2+/-2.8 episodes/patient/3 months vs. 0.3+/-0.8 episodes/patient/3 months after 1 year (P<0.01). The LVEF increased from 26+/-10 to 39+/-13% (P<0.001). NYHA class improved from 3. 17+/-0.3 to 1.8+/-0.6 (P<0.001) as well as right heart catheterization data. From the total cohort, seven patients (6%) developed symptomatic documented bradycardic rhythm disturbances requiring reprogramming of their pacemakers to DDD(R)/VVI(R) mode with higher basic rates. Two of these patients developed AV block, four sinu-atrial blocks or sinus bradycardia and one patient had bradycardic atrial fibrillation. During the observation period five patients died (3 sudden, 1 due to heart failure and 1 due to mesenteric infarction). Two patients had undergone heart transplants. The 1-year survival rate (Kaplan-Meier) without transplantation was 89%. Compared to historic control patients with amiodarone only (n=154) or without either agent (n=283) this rate was 64 and 57% (P<0.01).Conclusions: Heart failure patients benefit from a combined therapy with carvedilol and amiodarone resulting in a markedly improved NYHA stage, an increase in LV ejection fraction, a stabilization of sinus rhythm, a significant reduction in heart rate, a delay of electrical signal conduction and a suppression of ventricular ectopies. Approximately 6% of patients under such a regime became pacemaker-dependent in the first year. Compared to historic controls prognosis was better and the need for heart transplantation was lower. The exact role of either agent in combination or alone should be clarified in larger randomized studies. [ABSTRACT FROM AUTHOR]

Cardiac Resynchronization therapy (CRT) using coronary sinus (CS) leads is an established method for the therapy of congestive heart failure (CHF) in the case of inter- and intraventricular conduction delays. However implantation of CS leads is somewhat challenging due to a high number of peri- or postoperative dislocations at a rate of about 10%. The retained guidewire technique has been proposed for the implantation of coronary sinus leads for stabilization in case of repetitive intraoperative dislocations. This report describes CS lead and guidewire fracture 2 years after such an implant. [ABSTRACT FROM AUTHOR]