Search

Background: The benefit derived from implantable cardioverter-defibrillators (ICD) in subjects with non-ischemic systolic HF (NICM) is less well-established., Aim: The study aimed to determine the incidence, predictors, and prognostic impact of ventricular arrhythmias in patients with ICD and NICM., Methods: The study sample included 377 consecutive patients with ICD or cardiac resynchronization cardioverter-defibrillators (CRT-D, 74% of patients) and NICM implanted and monitored remotely in a university hospital., Results: During the median (interquartile range [IQR]) follow-up of 1645 (960-2675) days, sustained ventricular arrhythmia occurred in 92 patients (24.4%). Of those, ventricular fibrillation (VF), ventricular tachycardia (VT), and both VT and VF occurred in 10 (10.9%), 72 (78.3%), and 10 (10.9%) patients, respectively. Patients with vs. those without ventricular arrhythmia differed concerning sex, left ventricular end-diastolic diameter (LVEDD), left ventricular end-systolic diameter (LVESD), left ventricular ejection fraction (LVEF), post-inflammatory etiology, atrial fibrillation/flutter occurrence, and supraventricular arrhythmia (SVT) other than AF/AFL during follow-up. In multivariable Cox regression, LVEDD (hazard ratio [HR], 1.05; 95% confidence interval [CI], 1.003-1.09; P = 0.03), AF/AFL (HR, 1.86; 95% CI, 1.21-2.85; P = 0.004), and SVT (HR, 1.77; 95% CI, 1.10-2.87; P = 0.02) were independent predictors of sustained VT, while AF/AFL (HR, 1.65; 95% CI, 1.07-2.56; P = 0.02) was independent predictor of VF. All-cause mortality in patients with VT/VF was significantly higher than in subjects without sustained ventricular arrhythmias (35.9% vs. 22.4%; P = 0.01)., Conclusions: Ventricular arrhythmia occurred in every fourth patient with NICM and ICD during 4.5 years of observation and was associated with significantly worse prognosis than in subjects free of VT/VF. Higher LVEDD, atrial fibrillation/atrial flutter, and supraventricular tachycardia flag patients at risk of ventricular arrhythmia.

Aims: To assess and compare long-term mortality and predictors thereof in de novo cardiac resynchronization therapy defibrillators (CRT-D) vs. upgrade from an implantable cardioverter-defibrillator (ICD) to CRT-D., Methods and Results: Study population consisted of 595 consecutive patients with CRT-D implanted between 2002 and 2015 in a tertiary care, university hospital, in a densely inhabited, urban region of Poland [480 subjects (84.3%) with CRT-D de novo implantation; 115 patients (15.7%) upgraded from ICD to CRT-D]. In a median observation of 1692 days (range 457-3067), all-cause mortality for de novo CRT-D vs. CRT-D upgrade was 35.5% vs. 43.5%, respectively (P = 0.045). On multivariable regression analysis including all CRT recipients, the previously implanted ICD was an independent predictor for death [hazard ratio (HR) 1.58, 95% confidence interval (CI) 1.10-2.29, P = 0.02]. For those, who were upgraded from ICD to CRT-D, the independent predictors for all-cause death were as follows: creatinine level (HR 1.01, 95% CI 1.00-1.02, P = 0.01), left ventricular end-systolic diameter (HR 1.07, 95% CI 1.02-1.11, P = 0.002), New York Heart Association (NYHA) IV class at baseline (HR 2.36, 95% CI 1.00-5.53, P = 0.049) and cardiac device-related infective endocarditis during follow-up (HR 2.42, 95% CI 1.02-5.75, P = 0.046). A new CRT scale (Creatinine ≥150 μmol/L; Remodelling, left ventricular end-systolic ≥59 mm; Threshold for NYHA, NYHA = IV) showed high prediction for mortality in CRT-D upgrades (AUC 0.70, 95% CI 0.59-0.80, P = 0.0007)., Conclusion: All-cause mortality in patients upgraded from ICD is significantly higher compared with de novo CRT-D implantations and reaches almost 45% within 4.5 years. A new CRT scale (Creatinine; Remodelling; Threshold for NYHA) has been proposed to help survival prediction following CRT upgrade., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.)

Aims: The number of patients with heart failure (HF) and implantable cardiac electronic devices has been growing steadily. Remote monitoring care (RC) of cardiac implantable electronic devices can facilitate patient-healthcare clinical interactions and prompt preventive activities to improve HF outcomes. However, studies that have investigated the efficacy of remote monitoring have shown mixed findings, with better results for the system including daily verification of transmission. The purpose of the RESULT study was to analyse the impact of remote monitoring on clinical outcomes in HF patients with implantable cardioverter-defibrillator [ICD/cardiac resynchronization therapy-defibrillator (CRT-D)] in real-life conditions., Methods and Results: The RESULT is a prospective, single-centre, randomized trial. Patients with HF and de novo ICD or CRT-D implantation were randomized to undergo RC vs. in-office follow-ups (SC, standard care). The primary endpoint was a composite of all-cause death and hospitalization due to cardiovascular reasons within 12 months after randomization. We randomly assigned 600 eligible patients (299 in RC vs. 301 in SC). Baseline clinical and echocardiographic characteristics were well-balanced and similar in both arms. The incidence of the primary endpoint differed significantly between RC and SC and involved 39.5% and 48.5% of patients, respectively, (P = 0.048) within the 12-month follow-up. The rate of all-cause mortality was similar between the studied groups (6% vs. 6%, P = 0.9), whereas hospitalization rate due to cardiovascular reasons was higher in SC (37.1% vs. 45.5%, P = 0.045)., Conclusion: Remote monitoring of HF patients with implanted ICD or CRT-D significantly reduced the primary endpoint rate, mostly as a result of a lower hospitalization rate in the RC arm (ClinicalTrials.gov Identifier: NCT02409225)., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.)

Introduction: New pacing technologies offer a greater choice of left ventricular pacing sites and greater personalization of cardiac resynchronization therapy (CRT). The effects on cardiac function of novel pacing configurations are often compared using multi-beat averages of acute hemodynamic measurements. In this analysis of the iSpot trial, we explore whether this is sufficient., Materials and Methods: The iSpot trial was an international, prospective, acute hemodynamic trial that assessed seven CRT configurations: standard CRT, MultiSpot (posterolateral vein), and MultiVein (anterior and posterior vein) pacing. Invasive and noninvasive blood pressure, and left ventricular (LV) dP/dt max were recorded. Eight beats were recorded before and after an alternation from AAI to the tested pacing configuration and vice-versa. Eight alternations were performed for each configuration at each of the five atrioventricular delays., Results: Twenty-five patients underwent the full protocol of eight alternations. Only four (16%) patients had a statistically significant >3 mm Hg improvement over conventional CRT configuration (posterolateral vein, distal electrode). However, if only one alternation was analyzed (standard multi-beat averaging protocol), 15 (60%) patients falsely appeared to have a superior nonconventional configuration. Responses to pacing were significantly correlated between the different hemodynamic measures: invasive systolic blood pressure (SBP) vs noninvasive SBP r = 0.82 (P < .001); invasive SBP vs LV dP/dt r = 0.57, r 2  = 0.32 (P < .001)., Conclusions: Current standard multibeat acquisition protocols are unfortunately unable to prevent false impressions of optimality arising in individual patients. Personalization processes need to include distinct repeated transitions to the tested pacing configuration in addition to averaging multiple beats. The need is not only during research stages but also during clinical implementation., (© 2019 Wiley Periodicals, Inc.)

Background: Multiple randomised clinical trials have proven that cardiac resynchronisation therapy (CRT) reduces morbidity and mortality in appropriately selected patients with congestive heart failure and is recommended for such patients as per the European Society of Cardiology guidelines., Aim: In this paper we compare the indications and demographics in cardiac resynchronisation recipients in Poland and other European countries., Methods: In 2015 and 2016, physicians from 42 European countries participated in the second edition of the European Cardiac Resynchronisation Therapy Survey. For 14 months, 288 implanting centres gathered data regarding demography, indications, implanting methods, and guidance compatibility from 11,088 patients receiving CRT., Results: The survey revealed that a vast group of patients were eligible for CRT implantation (although some of them with rela-tively weak guidance recommendations) and showed essential variety in clinical practice when national data were benchmarked., Conclusions: The population of CRT recipients in Poland and other European countries did not differ in terms of demographic and clinical characteristics. In most cases, indications for CRT were in accordance with the guidelines; however some devices were implanted in patients beyond the guideline recommendations. For these procedures, the decision regarding CRT im-plantation relies mainly on the physicians' experience.

The number of patients with heart failure implantable cardiac electronic devices (CIEDs) is growing. Hospitalization rate in this group is very high and generates enormous costs. To avoid the need for hospital treatment, optimized monitoring and follow-up is crucial. Remote monitoring (RM) has been widely put into practice in the management of CIEDs but it may be difficult due to the presence of differences in systems provided by device manufacturers and loss of gathered data in case of device reimplantation. Additionally, conclusions derived from studies about usefulness of RM in clinical practice apply to devices coming only from a single company. An integrated monitoring platform allows for more comprehensive data analysis and interpretation. Therefore, the primary objective of Remote Supervision to Decrease Hospitalization Rate (RESULT) study is to evaluate the impact of RM on the clinical status of patients with ICDs or CRT-Ds using an integrated platform. Six hundred consecutive patients with ICDs or CRT-Ds implanted will be prospectively randomized to either a traditional or RM-based follow-up model. The primary clinical endpoint will be a composite of all-cause mortality or hospitalization for cardiovascular reasons within 12 months after randomization. The primary technical endpoint will be to construct and evaluate a unified and integrated platform for the data collected from RM devices manufactured by different companies. This manuscript describes the design and methodology of the prospective, randomized trial designed to determine whether remote monitoring using an integrated platform for different companies is safe, feasible, and efficacious (ClinicalTrials.gov Identifier: NCT02409225)., (© 2016 Wiley Periodicals, Inc.)

Objectives: Chronic heart failure (HF) is associated with significantly increased prevalence of depression. The aim of the study was to assess the incidence and clinical impact of depression as well as the effectiveness of depression treatment in HF patients., Methods: A prospective interventional trial included 285 consecutive cardiac resynchronization therapy recipients. Patients underwent a psychiatric examination at the time of implantation and then it was routinely repeated at 3, 6, and 12 months after the procedure, and every 6 months thereafter. One hundred and thirty-five (47.4%) patients with depression were included in the depression group, whereas the control group was comprised of 150 patients free of depression. Sixty-eight (50.4%) subjects received antidepressants (treated group), whereas the observational group had 67 (49.6%) depressed patients who refused to take antidepressants., Results: Depression remission was achieved in 51 (75.0%) patients from the treated group. Long-term mortality and HF hospitalization rates were significantly higher in the depression group than in the control group (20.7 vs. 11.3% and 32.6 vs. 19.2%, respectively). However, remission from depression was associated with a 40% reduction in the relative risk of major adverse cardiac events (MACE)., Conclusions: Patients with HF and concomitant depression are at higher risk of MACE compared with those free of depression. Effective antidepressant treatment may significantly improve long-term outcomes in this population., (© 2017 S. Karger AG, Basel.)

Background: Incidence and clinical significance of transient, daily fluctuations of biventricular pacing percentage (CRT%) remain unknown. We assessed the value of daily remote monitoring in identifying prognostically critical burden of low CRT%., Methods and Results: Prospective, single-centre registry encompassed 304 consecutive heart failure patients with cardiac resynchronization therapy defibrillators (CRT-D). Patients with 24-h episodes of CRT% loss<95% were assigned to quartiles depending on cumulative time spent in low CRT%: quartile 1 (1-8days), 2 (9-20days), 3 (21-60days) and quartile 4 (>60days). During median follow-up of 35months 51,826 transmissions were analysed, including 15,029 in 208 (68.4%) patients with episodes of low CRT%. Overall, mean CRT%≥95% vs. <95% resulted in a 4-fold lower mortality (17.3 vs. 68.2%; p<0.001). Fifty-four percent of patients experienced episodes of CRT% loss, despite 85.6% having mean CRT%≥95%. Mortality was lowest in quartile 1 (7.7%), while longer periods of CRT% loss resulted in significantly higher death rates (25.0 vs. 34.6 vs. 57.7%; quartiles 2-4 respectively, p<0.001), despite mean CRT% still being ≥95% in quartiles 1-3. Cumulative low CRT% burden was the independent risk factor for death (HR 1.013; 95% CI 1.006-1.021; p<0.001). Mortality rose by 1.3 and 49% with every additional day and quartile of CRT% loss, respectively., Conclusions: Daily remote monitoring allows one to detect 24-h episodes of CRT% loss<95% in over two-thirds of CRT-D recipients during median observation of 3years. Cumulative low CRT% burden (in days) independently predicts mortality before mean CRT% drop., (Copyright © 2016. Published by Elsevier Ireland Ltd.)

Background: A substantial proportion of patients do not respond to cardiac resynchronization therapy (CRT). Various echocardiographic and biochemical markers including collagen turnover biomarkers were suggested to predict CRT results. However, pathological significance of collagen turnover biomarkers in CRT remains controversial., Objective: The aim of the present study was to evaluate the relationship between levels of collagen turnover biomarkers (amino-terminal propeptide of procollagen type I and amino-terminal propeptide of procollagen type III [PIIINP]), N-terminal of the prohormone brain natriuretic peptide (NT-proBNP), high-sensitivity C-reactive protein, and matrix metalloproteinases (metalloproteinase-2 and metalloproteinase-9) and echocardiographic response to CRT and clinical outcomes., Methods: The study population consisted of patients enrolled in the Triple Site Versus Standard Cardiac Resynchronization Therapy trial. Blood samples were obtained before implantation of a CRT with defibrillator. The levels of PIIINP, amino-terminal propeptide of procollagen type I, metalloproteinase-2, and metalloproteinase-9 were determined using commercially available ELISA kits. High-sensitivity C-reactive protein and NT-proBNP levels were determined in a standard way., Results: Samples were collected from 74 of 100 enrolled patients. The multivariate logistic regression analysis demonstrated that low PIIINP levels (odds ratio [OR] 3.56; 95% confidence interval [CI] 1.23-10.24; P = .017) and baseline ejection fraction (OR 2.14; 95% CI 1.11-4.11; P = .02) were favorably associated with echocardiographic response. PIIINP and NT-proBNP levels appeared to be independent predictors of all-cause mortality (PIIINP: OR 3.11; 95% CI 1.21-7.89; P = .033; NT-proBNP: OR 2.05; 95% CI 1.11-4.96; P = .039) and risk of major cardiac adverse event (PIIINP: OR 3.56; 95% CI 1.53-9.15; P = .007; NT-proBNP: OR 4.51; 95% CI 1.75-11.6; P = .001). PIIINP levels showed significant additive value in predicting mortality as compared with NT-proBNP levels, but they were not superior to ejection fraction in predicting response. Survival analysis with cutoff values identified by receiver operating characteristic analysis confirmed a significant benefit associated with low baseline PIIINP levels., Conclusion: Low PIIINP levels are associated with favorable echocardiographic response and long-term survival in CRT recipients., (Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Introduction: Recent efforts to increase CRT response by multiSPOT pacing (MSP) from multiple bipols on the same left ventricular lead are still inconclusive., Aim: The Left Ventricular (LV) MultiSPOTpacing for CRT (iSPOT) study compared the acute hemodynamic response of MSP pacing by using 3 electrodes on a quadripolar lead compared with conventional biventricular pacing (BiV)., Methods: Patients with left bundle branch block (LBBB) underwent an acute hemodynamic study to determine the %change in LV+dP/dtmax from baseline atrial pacing compared to the following configurations: BiV pacing with the LV lead in a one of lateral veins, while pacing from the distal, mid, or proximal electrode and all 3 electrodes together (i.e. MSP). All measurements were repeated 4 times at 5 different atrioventricular delays. We also measured QRS-width and individual Q-LV durations., Results: Protocol was completed in 24 patients, all with LBBB (QRS width 171±20 ms) and 58% ischemic aetiology. The percentage change in LV+dP/dtmax for MSP pacing was 31.0±3.3% (Mean±SE), which was not significantly superior to any BiV pacing configuration: 28.9±3.2% (LV-distal), 28.3±2.7% (LV-mid), and 29.5±3.0% (LV-prox), respectively. Correlation between LV+dP/dtmax and either QRS-width or Q-LV ratio was poor., Conclusions: In patients with LBBB MultiSPOT LV pacing demonstrated comparable improvement in contractility to best conventional BiV pacing. Optimization of atrioventricular delay is important for the best performance for both BiV and MultiSPOT pacing configurations., Trial Registration: ClinicalTrials.gov NTC01883141.

Aims: The aim of the study was to verify in what proportion of patients, device-detected atrial high rate (AHR) episodes are indeed atrial arrhythmias (AAs). We investigated also the reasons for inappropriate arrhythmia classification and assessed if patients with misdiagnosed arrhythmias have distinct characteristics that would help to identify them., Methods and Results: The study population consisted of 304 consecutive patients implanted with cardiac resynchronization therapy defibrillators (CRT-Ds) and subsequently monitored via remote monitoring for a median follow-up (FU) of 30.5 months. Intracardiac electrograms of every recorded AHR episode were assessed and classified (AA vs. no AA) by two experienced cardiologists. During FU, 14 386 episodes of AHR were recorded and classified in 176 (57.9%) patients. In 89.2% of them, these episodes were true AA (94% atrial fibrillation, 62% de novo). The reasons for AHR misdiagnosis were atrial far-field signals (89.5%) and noise (10.5%). The mean per cent of day spent in AHR (54.9 vs. 5.86%; P < 0.001) and the occurrence of periods with low CRT pacing (82.8 vs. 55%; P = 0.003) were significantly higher in AA subjects than in those with misdiagnosed AHR. Episode duration of properly detected AHRs was longer than that of misdiagnosed AHRs. Higher per cent of time spent in AHR was an independent marker of appropriate arrhythmia detection [adjusted hazard ratio (HR) 1.04; P = 0.023]., Conclusion: Nearly two-thirds of CRT-D patients had AHR episodes within 2.5 years after implantation. Almost 90% of AHRs were indeed AA. Misdetections were caused by far-field sensing or noise. A two-step diagnostic algorithm (>9% of time spent in AHRs and episode duration >36 s) allowed for proper detection of AA with a high hit-rate and specificity., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.)

Background: Due to the recent rapid increase in the number of patients implanted with pacemakers, cardioverter-defibrillators (ICD), and cardiac resynchronisation therapy devices (CRT), conventional monitoring at specialist clinics is becoming increasingly difficult. The development of technology has enabled remote device monitoring with the use of teletransmission systems., Aim: To assess the effectiveness of transmission and the possibility of using telemetric data for further clinical management of patients with heart failure (HF) treated with CRT-D., Methods: The analysis included 305 consecutive patients with chronic HF, New York Heart Association functional classes II-IV, treated with the use of CRT-D by Biotronik or Medtronic in the years 2006-2012. The patients received transmitters, enabling the remote monitoring of the implanted device from the patients' houses. Scheduled reports were automatically sent every month. The triggers for pre-specified emergency alert transmissions were as follows: ventricular tachycardia (VT) or ventricular fibrillation (VF) episodes, CRT-D intervention, ventricular extrasystoles > 110/h, any episode of atrial fibrillation (AF), atrial flutter (AFL) or supraventricular tachycardia, mean heart rate (HR) during, mean 24-h HR, CRT pacing < 95%, Elective Replacement Indicator, or End Of Service and device malfunction. The all-cause mortality of the study population has been assessed at the end of the follow-up period (mean of 20.5 months)., Results: Devices manufactured by Biotronik were provided to 71% of the study population, while 29% received devices by Medtronic. In 97.3% of cases, the monitors were wireless, fully automatic, and capable of immediate data transmission whenever a pre-specified alert notification was fulfilled. The analysis of long-term outcomes revealed that all-cause mortality of the whole study population was 13%. The effectiveness of report transmission was 98%. During follow-up a total of 31,198 transmissions were received and analysed, which constituted, on average, 4.9 transmissions per patient per month. Among analyses, 30% were reports generated by scheduled remote follow-ups, and 70% were caused by unscheduled device alerts. Correct functioning of the system was confirmed; the quality of the received data was 100%. In 63.9% of patients, decisions based on the information obtained from telemonitoring reports were made to modify the therapy, refer the patients to cardiology or electrophysiology clinics, or hospitalise them urgently. The most common medical reaction was device reprogramming (46.8%). Pharmacotherapy was modified in 33.7% of patients: beta-blocker dose increase (25.9%), anticoagulant treatment inclusion (15.7%), amiodarone inclusion (1.9%), or digoxin inclusion (4.5%). The remaining medical responses were referring patients for atrioventricular junction ablation (8.1%), VT ablation (2.9%), or AF/AFl ablation (1.6%)., Conclusions: Remote monitoring of implantable devices is feasible, safe, and effective in supervising patients with CRT-D devices. Daily-based remote monitoring of a large population of HF patients allows continuous "triage" of high-risk patients and selection of individuals who require urgent intervention.

Background: The aim of this study was to evaluate the value of device-based diagnostic parameters in predicting ventricular arrhythmias in cardiac resynchronization therapy (CRT) recipients., Methods: Ninety-six CRT-D patients participating in TRUST CRT Trial were analyzed. The inclusion criteria were: heart failure in NYHA ≥ 3 class, QRS ≥ 120 ms, LVEF £ 35% and significant mechanical dyssynchrony. Patients were divided into those with (n = 31, 92 arrhythmias) and without (n = 65) appropriate ICD interventions within follow-up of 12.03 ± 6.7 months. Daily monitored device-based parameters: heart rate (HR), thoracic impedance (TI), HR variability and physical activity were analyzed in 4 time windows: within 10, 7, 3 days and 1 day before appropriate ICD interventions., Results: A consistent pattern of changes in three monitored factors was observed prior to arrhythmia: 1) a gradual increase of day HR (from 103.43% of reference within 10-day window to 105.55% one day before, all p < 0.05 vs. reference); 2) variations in night HR (104.75% in 3 days, 107.65% one day before, all p < 0.05) and 3) TI decrease (from 97.8% in 10 days to 96.81% one day before, all p < 0.05). The combination of three parameters had better predictive value, which improved further after exclusion of patients with atrial fibrillation (AF). The predictive model combining HR and TI together with LVEF and NT-proBNP was more prognostic than the model involving LVEF and NT-proBNP alone (difference in AUC 0.05, 95% CI 0.0005-0.09, p = 0.04)., Conclusions: Daily device-monitored parameters show significant variations prior to ventricular arrhythmia. Combination of multiple parameters improves arrhythmia predictive performance by its additive value to baseline risk factors, while presence of AF diminishes it.

Background and Aim: Currently, cardiac resynchronisation therapy (CRT) is recommended only for New York Heart Association (NYHA) class IV ambulatory patients. However, some recent reports have suggested that CRT could also be beneficial for end-stage inotrope-dependent heart failure (HF) NYHA class IV patients. In this report, we summarise the results of CRT implantation in a group of 11 HF inotrope-dependent patients who were not candidates for urgent orthotopic heart transplantation (OHT)., Methods and Results: Between August 2006 and June 2011, 11 end-stage inotrope-dependent HF patients with wide QRS complex, ineligible for urgent OHT, were implanted with CRT in the Silesian Centre for Heart Diseases in Zabrze. Dependence on inotropic therapy was defined as an inability to stop the infusion of the drug without the occurrence of hypotension, oligooranuria and/or hypoxaemia. All patients were successfully implanted with CRT and subsequently weaned from inotropes in a median time of two (1-17) days. Mean QRS duration shortened from 190 ± 34 ms at baseline to 142 ± 25 ms (p < 0.001) after the procedure. Average left ventricular ejection fraction increased from 19 ± 4% to 25 ± 4% (p < 0.001). All patients were discharged from hospital. Median hospital stay after the procedure was ten (5-56) days. During the median follow-upof 1,212 (182-2,048) days, four patients died (one due to arrhythmic storm, three others due to progressive pump failure). During that period, 57 adequate device interventions occurred in three patients, including 52 therapies in one fatal case., Conclusions: CRT can be an alternative for end-stage inotrope-dependent HF patients with wide QRS who are ineligible for urgent heart transplantation.

Aims: The aim of the study was to assess the predictive value for outcomes of various response criteria currently used in patients undergoing cardiac resynchronization therapy (CRT)., Methods and Results: Data from TRUST CRT randomized trial in patients with New York Heart Association (NYHA) III-IV class, QRS ≥ 120 ms, ejection fraction ≤ 35%, and mechanical dyssynchrony was analysed. Ninety-seven subjects who survived 6 months after implantation of CRT-defibrillator were classified as responders or non-responders depending on 15 criteria used in most of the previous trials. Blindly adjudicated data on major adverse cardiac events (MACEs) within 1 year after classification were used to calculate the predictive value of response criteria. After adjustment for baseline confounding variables only eight criteria were significantly predictive for future MACEs. Sensitivity and specificity ranged substantially for clinical (32-94% and 26-63%) and echocardiographic criteria (40-93% and 22-70%, respectively). The most powerful clinical predictor was >a NYHA class reduction ≥ 1 [adjusted relative risk (RR) 4.41 for non-responders; 95% confidence interval (CI) 1.75-11.04, P = 0.002], while the strongest echocardiographic predictor was a reduction in the left ventricular end-systolic index by > 15% (RR 3.49; 95% CI 1.59-7.64, P = 0.002). A combination of these two criteria did not improve the predictive value of a single parameter. Both criteria showed multiple significant interactions with baseline patients' characteristics., Conclusion: Only some of the commonly used response criteria predict outcome in patients undergoing CRT. The predictive value varies substantially across different criteria, with a higher sensitivity observed for the clinical parameters and a higher specificity observed for echocardiographic parameters. Combining various criteria adds little to their prognostic value. The predictive accuracy of various criteria can be different in various subgroups due to multiple interactions with baseline characteristics. CLINICALTRIALS. GOV IDENTIFIER: NCT00814840.

Background: The purpose of this study was to assess the effectiveness of cardiac resynchronization therapy (CRT) in terms of outflow tract gradient reduction and functional improvement in symptomatic patients with hypertrophic obstructive cardiomyopathy (HOCM) requiring implantable cardioverter-defibrillator (ICD) implantation., Methods: Eleven consecutive symptomatic HOCM patients with a significant (≥40 mmHg) gradient and indications for ICD, but without indications for resynchronization, underwent CRT-D implantation. Nine of them (four female, median age of 50 years) in whom the procedure succeeded were screened for New York Heart Association (NYHA) class, outflow gradient, mechanical dyssynchrony, QRS-width change, and 6-minute walking distance (6MWD) and peak oxygen consumption (VO(2)peak) improvement after 6 months and remotely., Results: After 6 months of pacing, NYHA class decreased (median 1 vs 2, respectively); peak (33 vs 84 mmHg) and mean (13 vs 38 mmHg) outflow tract gradients were reduced; and QRS width (143 vs 105 ms), intraventricular dyssynchrony (35 vs 55 ms), and VO(2)peak (19.5 vs 14.2 mL/kg/min) increased significantly (all P < 0.05) compared to baseline. In six of nine patients (67%), the peak gradient was reduced >50% and reached <40 mmHg. After a median of 36 months, the outflow gradient decreased even more (8 mmHg) and was significantly (P < 0.05) lower than after 6 months of CRT., Conclusions: These preliminary data suggest that CRT seems to be an effective method of reducing the outflow tract gradient and improving the functional status of symptomatic HOCM patients requiring ICD implantation. Our findings need to be confirmed by more extensive studies.

Background: Cardiac resynchronization therapy (CRT) reduces morbidity and mortality in patients with heart failure (HF), lowered LV ejection fraction, and wide QRS. However, many patients (< or =40%) do not respond to this form of pacing. TRUST CRT is a prospective, single-center, randomized, single-blind, parallel, and controlled study that has been designed to treat patients with moderate to severe HF (NYHA III-IV), QRS > or =120 ms, sinus rhythm, LV dysfunction (EF < or = 35%), and signs of mechanical dyssynchrony., Objective: The primary objective will evaluate the 6-month's combined endpoint of alive status, freedom from hospitalization for HF or heart transplantation, relative > or =10% increase in LV ejection fraction, > or =10% in peak oxygen consumption, and > or =10% in 6-minute walking distance., Methods: Patients with HF receiving optimal pharmacotherapy, with LV dysfunction, mechanical dyssynchrony, wide QRS and sinus rhythm will be randomized in a 1: 1 fashion to standard or triple-site CRT-D. Patients will be followed for 1 week, 1, 3, and 6 months during a blind phase, then every 6 months until study completion. One hundred patients will be enrolled by the study center., Conclusions: TRUST CRT is a randomized, clinical trial in CRT candidates to evaluate the effectiveness of triple-site pacing versus standard resynchronization in patients with HF.

Background: The primary objectives of this study were to compare the implantation course of triple-site (double left-single right) and conventional cardiac resynchronization devices. The secondary target was to assess mid-term outcomes of both types of cardiac resynchronization therapy (CRT)., Methods: Fifty-four patients with NYHA classes III-IV, left ventricular EFor=120 ms were included; 27 received triple-site pacemakers (TRIV group), 27 conventional CRT devices (BIV group). Procedural course, clinical data, QRS duration, echocardiographic parameters, peak oxygen consumption (VO2max) and 6-minute walking distance (6MWD) were screened for inter-group differences., Results: Procedure duration was higher in TRIV than in BIV group (197.6 vs. 137.6 min, P<0.001), fluoroscopy exposure and complication-rates were similar. After 3 months of CRT, triple-site pacing was associated with a more significant (P<0.05) NYHA class reduction (by 1.4 vs. 1.0 class, respectively), increase in VO(2) max (2.9 vs. 1.1 mL/kg/min) and 6MWD (98.7 vs. 51.6 m) than conventional CRT. A higher EF and more improved intraventricular synchrony were observed in the TRIV than in the BIV group. The response rate in the TRIV group was 96.3% vs. 62.9% in the conventional group (P=0.002). Triple-site stimulation was an independent predictor of response to CRT (adjusted odds ratio 26.4, P=0.01)., Conclusions: Triple-site resynchronization appears to be more beneficial than conventional CRT. Upgrade to triple-site CRT may be considered in non-responders to standard resynchronization.

Aims: To assess and compare long-term mortality and predictors thereof in de novo cardiac resynchronization therapy defibrillators (CRT-D) vs. upgrade from an implantable cardioverter-defibrillator (ICD) to CRT-D.Methods and Results: Study population consisted of 595 consecutive patients with CRT-D implanted between 2002 and 2015 in a tertiary care, university hospital, in a densely inhabited, urban region of Poland [480 subjects (84.3%) with CRT-D de novo implantation; 115 patients (15.7%) upgraded from ICD to CRT-D]. In a median observation of 1692 days (range 457-3067), all-cause mortality for de novo CRT-D vs. CRT-D upgrade was 35.5% vs. 43.5%, respectively (P = 0.045). On multivariable regression analysis including all CRT recipients, the previously implanted ICD was an independent predictor for death [hazard ratio (HR) 1.58, 95% confidence interval (CI) 1.10-2.29, P = 0.02]. For those, who were upgraded from ICD to CRT-D, the independent predictors for all-cause death were as follows: creatinine level (HR 1.01, 95% CI 1.00-1.02, P = 0.01), left ventricular end-systolic diameter (HR 1.07, 95% CI 1.02-1.11, P = 0.002), New York Heart Association (NYHA) IV class at baseline (HR 2.36, 95% CI 1.00-5.53, P = 0.049) and cardiac device-related infective endocarditis during follow-up (HR 2.42, 95% CI 1.02-5.75, P = 0.046). A new CRT scale (Creatinine ≥150 μmol/L; Remodelling, left ventricular end-systolic ≥59 mm; Threshold for NYHA, NYHA = IV) showed high prediction for mortality in CRT-D upgrades (AUC 0.70, 95% CI 0.59-0.80, P = 0.0007).Conclusion: All-cause mortality in patients upgraded from ICD is significantly higher compared with de novo CRT-D implantations and reaches almost 45% within 4.5 years. A new CRT scale (Creatinine; Remodelling; Threshold for NYHA) has been proposed to help survival prediction following CRT upgrade. [ABSTRACT FROM AUTHOR]

Aims: The number of patients with heart failure (HF) and implantable cardiac electronic devices has been growing steadily. Remote monitoring care (RC) of cardiac implantable electronic devices can facilitate patient-healthcare clinical interactions and prompt preventive activities to improve HF outcomes. However, studies that have investigated the efficacy of remote monitoring have shown mixed findings, with better results for the system including daily verification of transmission. The purpose of the RESULT study was to analyse the impact of remote monitoring on clinical outcomes in HF patients with implantable cardioverter-defibrillator [ICD/cardiac resynchronization therapy-defibrillator (CRT-D)] in real-life conditions.Methods and Results: The RESULT is a prospective, single-centre, randomized trial. Patients with HF and de novo ICD or CRT-D implantation were randomized to undergo RC vs. in-office follow-ups (SC, standard care). The primary endpoint was a composite of all-cause death and hospitalization due to cardiovascular reasons within 12 months after randomization. We randomly assigned 600 eligible patients (299 in RC vs. 301 in SC). Baseline clinical and echocardiographic characteristics were well-balanced and similar in both arms. The incidence of the primary endpoint differed significantly between RC and SC and involved 39.5% and 48.5% of patients, respectively, (P = 0.048) within the 12-month follow-up. The rate of all-cause mortality was similar between the studied groups (6% vs. 6%, P = 0.9), whereas hospitalization rate due to cardiovascular reasons was higher in SC (37.1% vs. 45.5%, P = 0.045).Conclusion: Remote monitoring of HF patients with implanted ICD or CRT-D significantly reduced the primary endpoint rate, mostly as a result of a lower hospitalization rate in the RC arm (ClinicalTrials.gov Identifier: NCT02409225). [ABSTRACT FROM AUTHOR]

Paced QRS Area Predicts CRT Response Introduction Vectorcardiographic (VCG) QRS area of left bundle branch block (LBBB) predicts acute hemodynamic response in cardiac resynchronization therapy (CRT) patients. We hypothesized that changes in QRS area occurring with biventricular pacing (BV) might predict acute hemodynamic CRT response (AHR). Methods and Results VCGs of 624 BV paced electrocardiograms (25 LBBB patients with 35 different pacing configurations) were calculated according to Frank's orthogonal lead system. Maximum QRS vector amplitudes (XAmpl, YAmpl, ZAmpl, and 3DAmp) and QRS areas (XArea, YArea, ZArea, and 3DArea) in the orthogonal leads (X, Y, and Z) and in 3-dimensional projection were measured. Volume of the 3D vector loop and global QRS duration (QRSD) on the surface electrocardiogram were assessed. Differences (Δ) in VCG parameters between BV paced and LBBB QRS complexes were calculated. An increase of 10% in dP/dt max was considered as AHR. LBBB conduction is characterized by a large ZArea (109 μVs, interquartile range [IQR]:75;135), significantly larger than XArea (22 μVs, IQR:10;57) and YArea (44 μVs, IQR:32;62, P < 0.001). Overall, QRS duration, amplitudes, and areas decrease significantly with BV pacing (P < 0.001). Of all VCG parameters, 3DAmpl, Δ3DAmpl, ZArea, ΔZArea, Δ3DArea, and ΔQRSD differentiate AHR response from nonresponse (P < 0.05). ΔZArea predicted best positive AHR (area under the curve = 0.813) and outperformed any other VCG parameter or QRSD measurement. Conclusion Of all VCG parameters, reduction in QRS area, calculated in Frank's Z lead, predicts acute hemodynamic response best. This method might be an easy, noninvasive tool to guide CRT implantation and optimization. [ABSTRACT FROM AUTHOR]

Aims: The aim of the study was to verify in what proportion of patients, device-detected atrial high rate (AHR) episodes are indeed atrial arrhythmias (AAs). We investigated also the reasons for inappropriate arrhythmia classification and assessed if patients with misdiagnosed arrhythmias have distinct characteristics that would help to identify them.Methods and Results: The study population consisted of 304 consecutive patients implanted with cardiac resynchronization therapy defibrillators (CRT-Ds) and subsequently monitored via remote monitoring for a median follow-up (FU) of 30.5 months. Intracardiac electrograms of every recorded AHR episode were assessed and classified (AA vs. no AA) by two experienced cardiologists. During FU, 14 386 episodes of AHR were recorded and classified in 176 (57.9%) patients. In 89.2% of them, these episodes were true AA (94% atrial fibrillation, 62% de novo). The reasons for AHR misdiagnosis were atrial far-field signals (89.5%) and noise (10.5%). The mean per cent of day spent in AHR (54.9 vs. 5.86%; P < 0.001) and the occurrence of periods with low CRT pacing (82.8 vs. 55%; P = 0.003) were significantly higher in AA subjects than in those with misdiagnosed AHR. Episode duration of properly detected AHRs was longer than that of misdiagnosed AHRs. Higher per cent of time spent in AHR was an independent marker of appropriate arrhythmia detection [adjusted hazard ratio (HR) 1.04; P = 0.023].Conclusion: Nearly two-thirds of CRT-D patients had AHR episodes within 2.5 years after implantation. Almost 90% of AHRs were indeed AA. Misdetections were caused by far-field sensing or noise. A two-step diagnostic algorithm (>9% of time spent in AHRs and episode duration >36 s) allowed for proper detection of AA with a high hit-rate and specificity. [ABSTRACT FROM AUTHOR]

Background The prognostic impact of improvement in health-related quality of life (QoL) and its relation to response in cardiac resynchronization therapy (CRT) recipients remains unknown. Aim To assess the correspondence between response to CRT and improvements in QoL and to verify if a change in QoL after pacing influences outcome in CRT patients. Methods Ninety-seven participants of the Triple-Site Versus Standard Cardiac Resynchronization Therapy Trial (TRUST CRT) randomized trial, in New York Heart Association class III-IV, QRS width ≥ 120 ms, left ventricular ejection fraction ≤35%, and significant mechanical dyssynchrony were included. Subjects filled out the Minnesota-QoL questionnaire prior to and 6 months after CRT with defibrillator (CRT-D) implantation. Data on major adverse cardiac events (MACEs: death, heart failure hospitalization, heart transplant) collected within the next 2.5 years and adjudicated blindly constituted the censoring variables. Results Within the first 6 months of resynchronization QoL improved in 81%, while worsening in 19% of patients. Clinical response, but not the echocardiographic one, was associated with improved QoL. During subsequent 2.5 years MACEs occurred in 37% of patients (23% died). Subjects without QoL improvement were significantly (both P < 0.05) more prone to experience MACE (61% vs 32%) and die (44% vs 18%) within the follow-up. Unimproved QoL increased the probability of future MACE by 2.7 times (95% confidence intervals [CI]: 1.26-5.83; P = 0.01) and death by 3.2 times (95% CI: 1.23-8.32; P = 0.02) independently from clinical and echocardiographic response. Conclusions Clinical response, but not the echocardiographic one, was associated with improved QoL in CRT recipients. These preliminary data suggest that lack of improvement in QoL after CRT was associated with a strongly unfavorable prognosis, regardless of functional or echocardiographic response. Our results merit further studies with a larger number of patients. [ABSTRACT FROM AUTHOR]

Background: Silent atrial fibrillation (SAF) is common and is associated with poor outcomes. Aims: to study the risk factors for AF and SAF in the elderly (≥65 years) general population and to develop a risk stratification model for predicting SAF. Methods: Continuous ECG monitoring was performed for up to 30 days using a vest-based system in a cohort from NOMED-AF, a cross-sectional study based on a nationwide population sample. The independent risk factors for AF and SAF were determined using multiple logistic regression. ROC analysis was applied to validate the developed risk stratification score. Results: From the total cohort of 3014 subjects, AF was diagnosed in 680 individuals (mean age, 77.5 ± 7.9; 50.1% men) with AF, and, of these, 41% had SAF. Independent associations with an increased risk of AF were age, male gender, coronary heart disease, thyroid diseases, prior ischemic stroke or transient ischemic attack (ICS/TIA), diabetes, heart failure, chronic kidney disease (CKD), obesity, and NT-proBNP >125 ng/mL. The risk factors for SAF were age, male gender, ICS/TIA, diabetes, heart failure, CKD, and NT-proBNP >125 ng/mL. We developed a clinical risk scale (MR-DASH score) that achieved a good level of prediction in the derivation cohort (AUC 0.726) and the validation cohort (AUC 0.730). Conclusions: SAF is associated with various clinical risk factors in a population sample of individuals ≥65 years. Stratifying individuals from the general population according to their risk for SAF may be possible using the MR-DASH score, facilitating targeted screening programs of individuals with a high risk of SAF. [ABSTRACT FROM AUTHOR]

Aim To assess incidence, predisposing factors and outcomes of cardiac device-related infective endocarditis (CDRIE) in patients undergoing cardiac resynchronization therapy (CRT). Methods and results High-volume, single-center cardiology database was screened to identify all CDRIE cases, based on modified Duke criteria, amongst 765 consecutive CRT implantations between 2002 and 2015 (70.8% de novo implantations, 13.7% and 15.5% up-grades from pacemaker and implantable cardioverter–defibrillator [ICD], respectively). During the median follow-up (FU) of 1207 days (range: 256–2664) overall 38 CDRIE (4.97%) cases were identified (incidence: 15/1000 person-years). Multivariate Cox regression model, incorporating significant baseline differences as covariates (model 1), demonstrated that both up-grade from ICD to CRT and higher baseline NYHA class were independently associated with increased risk of CDRIE (adjusted HR 4.29, 95%CI 1.93–9.57; and HR 2.43, 95%CI 1.32–4.49, respectively). In the second model (including all differences with P < 0.2) up-grade from ICD (HR 4.36, 95%CI 1.96–9.69), higher NYHA class (HR 2.04, 95%CI 1.11–3.75), hypertrophic cardiomyopathy (HR 5.85, 95% CI 1.46–23.52), lower baseline hemoglobin level (HR 0.68, 95%CI 0.50–0.94) and chronic obstructive pulmonary disease (HR 2.46, 95%CI 1.05–5.77) were all independently associated with higher risk of CDRIE. All-cause mortality in patients with CDRIE was significantly higher than in subjects without infective complications (68.4% vs. 33.7%, P < 0.001), and 50% of patients with CDRIE died during index hospitalization. Conclusions The prevalence of CDRIE in CRT recipients is almost 5% within 3.5 years post implantation. Up-grade from ICD and high baseline NYHA class flag up patients at high-risk of CDRIE. CRT-related infective complications are associated with very poor prognosis. [ABSTRACT FROM AUTHOR]