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Aims: Female sex is considered an independent risk factor of transvenous leads extraction (TLE) procedure. The aim of the study was to evaluate the effectiveness of TLE in women compared with men.Methods and Results: A post hoc analysis of risk factors and effectiveness of TLE in women and men included in the ESC-EHRA EORP ELECTRa registry was conducted. The rate of major complications was 1.96% in women vs. 0.71% in men; P = 0.0025. The number of leads was higher in men (mean 1.89 vs. 1.71; P < 0.0001) with higher number of abandoned leads in women (46.04% vs. 34.82%; P < 0.0001). Risk factors of TLE differed between the sexes, of which the major were: signs and symptoms of venous occlusion [odds ratio (OR) 3.730, confidence interval (CI) 1.401-9.934; P = 0.0084], cumulative leads dwell time (OR 1.044, CI 1.024-1.065; P < 0.001), number of generator replacements (OR 1.029, CI 1.005-1.054; P = 0.0184) in females and the number of leads (OR 6.053, CI 2.422-15.129; P = 0.0001), use of powered sheaths (OR 2.742, CI 1.404-5.355; P = 0.0031), and white blood cell count (OR 1.138, CI 1.069-1.212; P < 0.001) in males. Individual radiological and clinical success of TLE was 96.29% and 98.14% in women compared with 98.03% and 99.21% in men (P = 0.0046 and 0.0098).Conclusion: The efficacy of TLE was lower in females than males, with a higher rate of periprocedural major complications. The reasons for this difference are probably related to disparities in risk factors in women, including more pronounced leads adherence to the walls of the veins and myocardium. Lead management may be key to the effectiveness of TLE in females. [ABSTRACT FROM AUTHOR]

Aims: The present study sought to determine predictors for success and outcomes of patients who underwent cardiac implantable electronic devices (CIED) extraction indicated for systemic or local CIED related infection in particular where complete lead removal could not be achieved.Methods and Results: ESC-EORP ELECTRa (European Lead Extraction ConTRolled Registry) is a European prospective lead extraction registry. Out of the total cohort, 1865/3510 (52.5%) patients underwent removal due to CIED related infection. Predictors and outcomes of failure were analysed. Complete removal was achieved in 1743 (93.5%) patients, partial (<4 cm of lead left) in 88 (4.7%), and failed (>4 cm of lead left) in 32 (1.8%) patients. Removal success was unrelated to type of CIED infection (pocket or systemic). Predictors for failure were older leads and older patients [odds ratio (OR) 1.14 (1.08-1.19), P < 0.0001 and OR 2.68 (1.22-5.91), P = 0.0146, respectively]. In analysis by lead, predictors for failure were: pacemaker vs. defibrillator removal and failure to engage the locking stylet all the way to the tip [OR 0.20 (0.04-0.95), P = 0.03 and OR 0.32 (0.13-0.74), P = 0.008, respectively]. Significantly higher complication rates were noted in the failure group (40.6% vs. 15.9 for partial and 8.7% for success groups, P < 0.0001). Failure to remove a lead was a strong predictor for in hospital mortality [hazard ratio of 2.05 (1.01-4.16), P = 0.046].Conclusion: A total of 6.5% of infected CIED patients failed attempted extraction. Only were >4 cm of lead remained resulted in higher procedural complications and mortality rates. [ABSTRACT FROM AUTHOR]

Background: To date, there are no data from randomized controlled studies on the benefit of cardiac resynchronization therapy (CRT) when implanted as an upgrade in patients with a previous device as compared to de novo CRT. In the CRT Survey II we compared the baseline data of patients upgraded to CRT (CRT-P/CRT-D) from a previous pacemaker (PM) or implantable cardioverter-defibrillator (ICD) to de novo CRT implantation.Methods and Results: In the European CRT Survey II, clinical practice data of patients undergoing CRT and/or ICD implantation across 42 European Society of Cardiology (ESC) countries were collected between October 2015 and December 2016. Out of a total of 11 088 patients, 2396 (23.2%) were upgraded from a previous PM or ICD and 7933 (76.8%) underwent de novo implantation. Compared to de novo implantations, upgraded patients were older, more often male, more frequently had ischaemic heart failure aetiology, atrial fibrillation, reduced renal function, worse heart failure symptoms, and higher N-terminal pro-B-type natriuretic peptide levels. Upgraded patients were more often PM-dependent and less frequently received CRT-D. Total peri-procedural, in-hospital complications and length of hospital stay were similar. Upgraded patients were less frequently treated with heart failure medication at discharge.Conclusion: Despite a lack of evidenced-based data, close to one quarter of all CRT implantations across 42 ESC countries were upgrades from a previous PM or ICD. Despite older age and worse symptoms, the CRT implantation procedures in upgraded patients were equally frequently successful and complications similar to de novo implantations. These results call for more studies. [ABSTRACT FROM AUTHOR]

Background: Cardiac resynchronisation therapy (CRT) reduces morbidity and mortality in appropriately selected patients with heart failure and is strongly recommended for such patients by guidelines. A European Society of Cardiology (ESC) CRT survey conducted in 2008-2009 showed considerable variation in guideline adherence and large individual, national and regional differences in patient selection, implantation practice and follow-up. Accordingly, two ESC associations, the European Heart Rhythm Association and the Heart Failure Association, designed a second prospective survey to describe contemporary clinical practice regarding CRT.Methods and Results: A survey of the clinical practice of CRT-P and CRT-D implantation was conducted from October 2015 to December 2016 in 42 ESC member countries. Implanting centres provided information about their hospital and CRT service and were asked to complete a web-based case report form collecting information on patient characteristics, investigations, implantation procedures and complications during the index hospitalisation. The 11 088 patients enrolled represented 11% of the total number of expected implantations in participating countries during the survey period; 32% of patients were aged ≥75 years, 28% of procedures were upgrades from a permanent pacemaker or implantable cardioverter-defibrillator and 30% were CRT-P rather than CRT-D. Most patients (88%) had a QRS duration ≥130 ms, 73% had left bundle branch block and 26% were in atrial fibrillation at the time of implantation. Large geographical variations in clinical practice were observed.Conclusion: CRT Survey II provides a valuable source of information on contemporary clinical practice with respect to CRT implantation in a large sample of ESC member states. The survey permits assessment of guideline adherence and demonstrates variations in patient selection, management, implantation procedure and follow-up strategy. [ABSTRACT FROM AUTHOR]

Aims To assess the cost-effectiveness and the cost utility of remote patient monitoring (RPM) when compared with the usual care approach based upon differences in the number of hospitalizations, estimated from a meta-analysis of randomized clinical trials (RCTs). Methods and results We reviewed the literature published between January 2000 and September 2009 on multidisciplinary heart failure (HF) management, either by usual care or RPM to retrieve the number of hospitalizations and length of stay (LOS) for HF and for any cause. We performed a meta-analysis of 21 RCTs (5715 patients). Remote patient monitoring was associated with a significantly lower number of hospitalizations for HF [incidence rate ratio (IRR): 0.77, 95% CI 0.65–0.91, P < 0.001] and for any cause (IRR: 0.87, 95% CI: 0.79–0.96, P = 0.003), while LOS was not different. Direct costs for hospitalization for HF were approximated by diagnosis-related group (DRG) tariffs in Europe and North America and were used to populate an economic model. The difference in costs between RPM and usual care ranged from €300 to €1000, favouring RPM. These cost savings combined with a quality-adjusted life years (QALYs) gain of 0.06 suggest that RPM is a ‘dominant’ technology over existing standard care. In a budget impact analysis, the adoption of an RPM strategy entailed a progressive and linear increase in costs saved. Conclusions The novel cost-effectiveness data coupled with the demonstrated clinical efficacy of RPM should encourage its acceptance amongst clinicians and its consideration by third-party payers. At the same time, the scientific community should acknowledge the lack of prospectively and uniformly collected economic data and should request that future studies incorporate economic analyses. [ABSTRACT FROM PUBLISHER]

Aims The aim of this study was to investigate (i) the baseline patterns of segmental peak myocardial strain (PMS) in heart failure (HF) patients with ventricular conduction delay, (ii) changes in patterns of segmental PMS induced by cardiac resynchronization therapy (CRT), and (iii) whether they differ between CRT responders and non-responders. Methods and results Segmental and global longitudinal (L-) and radial (R-) PMS measurements derived from speckle tracking were prospectively obtained in 85 HF patients with intraventricular conduction delay before and 6 months after CRT device implantation and in 30 healthy subjects. Segmental strain analysis in HF patients showed pronounced heterogeneity both in longitudinal and in radial directions with the lowest amplitudes in the septum and the highest amplitudes in the lateral and posterior walls. After CRT, 60% of the patients were responders (≥15% reduction in end-systolic volume). Before CRT, responders showed higher global R-PMS than non-responders (19.5 ± 13.4 vs.13.1 ± 4.8%, respectively; P = 0.04) despite similar global L-PMS. After CRT, responders showed an increase in L-PMS in most segments and a homogeneous increase in R-PMS, leading to a more uniform pattern of strain and an improved global L-PMS and R-PMS. In contrast, in non-responders, the gain in L-PMS and R-PMS in septal segments was completely offset by a decrease in posterolateral segments, failing to decrease segmental heterogeneity and to increase global L-PMS and R-PMS. Conclusion Heart failure patients with ventricular conduction delay show pronounced heterogeneous patterns of segmental PMS, which can be reversed by CRT. [ABSTRACT FROM AUTHOR]

Aims: Female sex is considered an independent risk factor of transvenous leads extraction (TLE) procedure. The aim of the study was to evaluate the effectiveness of TLE in women compared with men., Methods and Results: A post hoc analysis of risk factors and effectiveness of TLE in women and men included in the ESC-EHRA EORP ELECTRa registry was conducted. The rate of major complications was 1.96% in women vs. 0.71% in men; P = 0.0025. The number of leads was higher in men (mean 1.89 vs. 1.71; P < 0.0001) with higher number of abandoned leads in women (46.04% vs. 34.82%; P < 0.0001). Risk factors of TLE differed between the sexes, of which the major were: signs and symptoms of venous occlusion [odds ratio (OR) 3.730, confidence interval (CI) 1.401-9.934; P = 0.0084], cumulative leads dwell time (OR 1.044, CI 1.024-1.065; P < 0.001), number of generator replacements (OR 1.029, CI 1.005-1.054; P = 0.0184) in females and the number of leads (OR 6.053, CI 2.422-15.129; P = 0.0001), use of powered sheaths (OR 2.742, CI 1.404-5.355; P = 0.0031), and white blood cell count (OR 1.138, CI 1.069-1.212; P < 0.001) in males. Individual radiological and clinical success of TLE was 96.29% and 98.14% in women compared with 98.03% and 99.21% in men (P = 0.0046 and 0.0098)., Conclusion: The efficacy of TLE was lower in females than males, with a higher rate of periprocedural major complications. The reasons for this difference are probably related to disparities in risk factors in women, including more pronounced leads adherence to the walls of the veins and myocardium. Lead management may be key to the effectiveness of TLE in females., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: journals.permissions@oup.com.)

Aims: The present study sought to determine predictors for success and outcomes of patients who underwent cardiac implantable electronic devices (CIED) extraction indicated for systemic or local CIED related infection in particular where complete lead removal could not be achieved., Methods and Results: ESC-EORP ELECTRa (European Lead Extraction ConTRolled Registry) is a European prospective lead extraction registry. Out of the total cohort, 1865/3510 (52.5%) patients underwent removal due to CIED related infection. Predictors and outcomes of failure were analysed. Complete removal was achieved in 1743 (93.5%) patients, partial (<4 cm of lead left) in 88 (4.7%), and failed (>4 cm of lead left) in 32 (1.8%) patients. Removal success was unrelated to type of CIED infection (pocket or systemic). Predictors for failure were older leads and older patients [odds ratio (OR) 1.14 (1.08-1.19), P < 0.0001 and OR 2.68 (1.22-5.91), P = 0.0146, respectively]. In analysis by lead, predictors for failure were: pacemaker vs. defibrillator removal and failure to engage the locking stylet all the way to the tip [OR 0.20 (0.04-0.95), P = 0.03 and OR 0.32 (0.13-0.74), P = 0.008, respectively]. Significantly higher complication rates were noted in the failure group (40.6% vs. 15.9 for partial and 8.7% for success groups, P < 0.0001). Failure to remove a lead was a strong predictor for in hospital mortality [hazard ratio of 2.05 (1.01-4.16), P = 0.046]., Conclusion: A total of 6.5% of infected CIED patients failed attempted extraction. Only were >4 cm of lead remained resulted in higher procedural complications and mortality rates., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: journals.permissions@oup.com.)

Objectives: This study sought to compare sex difference for procedural aspects and complications in the European Society of Cardiology CRT Survey II, exploring whether adverse events were related to the type of CRT device implanted., Background: Sex-related differences in procedural aspects and complications in patients undergoing cardiac resynchronization therapy (CRT) implantation has not been explored in a real-life population., Methods: A post-hoc analysis of procedural data and complications in different sexes and factors associated with events was performed from data collected in the European Society of Cardiology CRT Survey II., Results: Of all patients (n = 11,088) included, 24.3% were women. The mean age (70 years of age) of male and female recipients was similar. Female patients more frequently had an idiopathic cardiomyopathy (67.4% vs. 44.1%) and fewer comorbidities, including atrial fibrillation (34.8% vs. 42.8%), diabetes (29.1% vs. 32.1%), chronic obstructive lung disease (10.3% vs. 12.6%), and renal failure (28.7% vs. 31.9%), compared with men. More women compared with men had a pacemaker (56.6% vs. 46.3%) and much less often an implantable cardioverter-defibrillator (CRT-D) (19.0% vs. 34.7%) implant. Periprocedural event rate was the highest in women with CRT with defibrillator (7.1% vs. 4.8% in men), followed by women with a CRT with pacing (5.5% vs. 4.4% in men). The higher periprocedural event rate in CRT-D women was attributable primarily to the occurrence of pneumothorax (1.4%), coronary sinus dissection (2.1%), and pericardial tamponade (0.3%). The rate of in-hospital major adverse events (6.0%) and complications necessitating reoperation (4.0%) was not different among sex and device type., Conclusions: Women are more likely to experience adverse procedure-related events during CRT implantation. Thus, preventive strategies should be employed to minimize complication rate., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: A sub-analysis of the ESC-EHRA European Lead Extraction ConTRolled (ELECTRa) Registry to evaluate the clinical impact of antithrombotic (AT) on transvenous lead extraction (TLE) safety and efficacy., Methods and Results: ELECTRa outcomes were compared between patients without AT therapy (No AT Group) and with different pre-operative AT regimens, including antiplatelets (AP), anticoagulants (AC), or both (AP + AC). Out of 3510 pts, 2398 (68%) were under AT pre-operatively. AT patients were older with more comorbidities (P < 0.0001). AT subgroups, defined as AP, AC, or AP + AC, were 1096 (31.2%), 985 (28%), and 317 (9%), respectively. Regarding AP patients, 1413 (40%) were under AP, 1292 (91%) with a single AP, interrupted in 26% about 3.8 ± 3.7 days before TLE. In total, 1302 (37%) patients were under AC, 881 vitamin K antagonist (68%), 221 (17%) direct oral anticoagulants, 155 (12%) low weight molecular heparin, and 45 (3.5%) unfractionated heparin. AC was 'interrupted without bridging' in 696 (54%) and 'interrupted with bridging' in 504 (39%) about 3.3 ± 2.3 days before TLE, and 'continued' in 87 (7%). TLE success rate was high in all subgroups. Only overall in-hospital death (1.4%), but not the procedure-related one, was higher in the AT subgroups (P = 0.0500). Age >65 years and New York Heart Association Class III/IV, but not AT regimens, were independent predictors of death for any cause. Haematomas were more frequent in AT subgroups, especially in AC 'continued' (P = 0.025), whereas pulmonary embolism in the No-AT (P < 0.01)., Conclusions: AT minimization is safe in patients undergoing TLE. AT does not seem to predict death but identifies a subset of fragile patients with a worse in-hospital TLE outcome., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: journals.permissions@oup.com.)

Introduction: Little data are available on anticoagulation (AC) management in patients with cardiac resynchronization (CRT) devices who undergo transvenous lead extraction (TLE) procedure. We investigated the impact of AC on periprocedural complications in CRT patients undergoing TLE, enrolled in the ESC-EHRA European Lead Extraction ConTrolled (ELECTRa) registry., Methods and Results: All CRT patients treated with TLE enrolled in the registry were considered. Perioperative AC management was left to the discretion of the Center. Major and minor intraprocedural and postprocedural complications were compared between patients without AC (Gp1) and patients with AC (Gp2). Regression analyses were performed to identify predictors of complications for Gp2. Out of 734 CRT pts, 328 (44.7%) were under AC (Gp2). Patients from Gp2 presented lower LVEF (Gp2 32.5 ± 10.9 vs Gp1 34.5 ± 11.9%; P = 0.03), more advanced heart failure disease (NYHA III/IV: Gp2 42.0 vs Gp1 31.5%; P = 0.02), and renal impairment (Gp2 39.0 vs Gp1 24.3%; P < 0.001). Perioperative regimens included AC interruption (Gp2A: n = 169, 51.5%), "bridging" (Gp2B: n = 135, 41.2%), or continued AC (Gp2C: n = 24, 7.3%). TLE complete success rates (98% in both groups) and major complication rates were comparable for both groups; minor bleeding events were more frequent in Gp2 (5.5%) compared to Gp1 (2.5%; P = 0.051). No independent predictors were identified for Gp2, but minor complications were associated with "bridging" approach (Gp2B: 16 events vs Gp2A/C: 9 events; P = 0.020)., Conclusion: CRT patients treated with TLE under AC were more compromised but did not present more major complications compared to patients without AC. More minor complications were associated with "bridging" AC regimen., (© 2019 Wiley Periodicals, Inc.)

Clinicians accept that there are many unknowns when we make diagnostic and therapeutic decisions. Acceptance of uncertainty is essential for the pursuit of the profession: bedside decisions must often be made on the basis of incomplete evidence. Over the years, physicians sometimes even do not realize anymore which the fundamental gaps in our knowledge are. As clinical scientists, however, we have to halt and consider what we do not know yet, and how we can move forward addressing those unknowns. The European Heart Rhythm Association (EHRA) believes that scanning the field of arrhythmia / cardiac electrophysiology to identify knowledge gaps which are not yet the subject of organized research, should be undertaken on a regular basis. Such a review (White Paper) should concentrate on research which is feasible, realistic, and clinically relevant, and should not deal with futuristic aspirations. It fits with the EHRA mission that these White Papers should be shared on a global basis in order to foster collaborative and needed research which will ultimately lead to better care for our patients. The present EHRA White Paper summarizes knowledge gaps in the management of atrial fibrillation, ventricular tachycardia/sudden death and heart failure., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: journals.permissions@oup.com.)

Aims: The decision to implant a cardiac resynchronization therapy pacemaker (CRT-P) or a cardiac resynchronization therapy defibrillator (CRT-D) may be challenging. There are no clear guideline recommendations as no randomized study of cardiac resynchronization therapy (CRT) has been designed to compare the effects of CRT-P with those of CRT-D on patients' outcomes. In the CRT Survey II, we studied patient and implantation centre characteristics associated with the choice of CRT-P vs. CRT-D., Methods and Results: Clinical practice data from 10 692 patients undergoing CRT implantation of whom 7467 (70%) patients received a CRT-D and 3225 (30%) received a CRT-P across 42 ESC countries were collected and analysed between October 2015 and January 2017. Factors favouring the selection of CRT-P implantation included age >75 years, female gender, non-ischaemic heart failure (HF) aetiology, New York Heart Association functional Class III/IV symptoms, left ventricular ejection fraction >25%, atrial fibrillation, atrioventricular (AV) block II/III, and implantation in a university hospital., Conclusion: In a large cohort from the CRT Survey II, we found that patients allocated to receive CRT-P exhibited particular phenotypes with more symptomatic HF, more frequent comorbidities, advanced age, female gender, non-ischaemic HF aetiology, atrial fibrillation, and evidence of AV block. There were substantial differences in the proportion of patients allocated to receive CRT-P vs. CRT-D between countries., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: journals.permissions@oup.com.)

Aims: We aimed at describing outcomes and predictors of cardiac avulsion or tear (CA/T) with tamponade and vascular avulsion or tear (VA/T) after transvenous lead extraction (TLE) in the ESC-EHRA European Lead Extraction ConTRolled (ELECTRa) registry., Methods and Results: A total of 3555 consecutive patients of whom 3510 underwent TLE at 73 centres in 19 European countries were enrolled. Among 58 patients (1.7%) with procedure-related major complications, 49 (84.5%) patients (30 CA/T and 19 VA/T) presented cardiovascular complications requiring pericardiocentesis, chest tube positioning and/or surgical repair. The mortality was 20% in patients with tamponade due to CA/T and 31.6% in patients with VA/T. Pericardiocentesis as first manoeuvre followed by rescue surgical repair was highly effective in case of CA/T (93.8%). At multivariate analysis, CA/T with tamponade was more common in RIATA lead extraction, female patients, leads with a mean dwelling time more than 10 years, and when ≥3 leads were extracted or multiple sheaths required. Occlusion or critical stenosis of superior venous access and the leads mean dwelling time more than 10 years were independent predictors for VA/T, while mechanical dilatation was an independent predictor of a lower incidence of this complication as compared to the use of powered sheaths., Conclusions: In the ELECTRa registry, RIATA lead extraction and superior venous access occlusion/thrombosis are two new independent predictors for cardiac tamponade and major vascular complications, respectively. The use of mechanical sheaths seems to be associated with a lower incidence of VA/T. A strategy of pericardiocentesis followed by a rescue surgical approach seems to be reasonable in order to treat a CA/T with tamponade., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2018. For permissions, please email: journals.permissions@oup.com.)

Aim: Between October 2015 and December 2016, 11,088 patients from 42 countries having cardiac resynchronisation therapy (CRT) devices implanted were included in the CRT II Survey. We compared the characteristics of Swiss CRT recipients with the overall European population., Methods: Demographic and procedural data from seven Swiss centres recruiting all consecutive patients undergoing either de-novo CRT implantation or an upgrade to a CRT system were collected and compared with the European population., Results: A total of 320 Swiss patients (24.4% female, mean age 71.0 ± 10.2 years, 47% ischaemic cardiomyopathy) were enrolled, which amounts to 38% of all CRT implantations in Switzerland during this period. Of the patients enrolled, 38% had atrial fibrillation, 27% second- or third-degree atrioventricular block, and 68% complete left bundle-branch block. Swiss patients had significantly less often the classical indication of heart failure with a wide QRS complex (40 vs 61%; odds ratio [OR] 0.44, 95% confidence interval [CI] 0.35-0.55; p <0.001). Compared with the European population, Swiss patients were significantly older (71 vs 68.5 years, p <0.001), less symptomatic from heart failure and had more chronic kidney disease. Swiss patients significantly more often received a CRT-pacemaker (37 vs 30%; OR 1.37; 95% CI 1.09-1.73; p = 0.007) and quadripolar left ventricular leads (69 vs 57%; OR 1.67, 95% CI 1.32-2.13; p <0.001)., Conclusion: Compared with European CRT recipients, Swiss CRT patients are older, less symptomatic and suffer more often from comorbidities. Although two thirds of the implantations were CRT-defibrillator systems, Swiss patients more often received CRT-pacemaker systems than their European counterparts.

Aims: Subcutaneous implantable cardioverter-defibrillator (S-ICD) can avoid important complications associated with transvenous leads in patients with inherited primary arrhythmia syndromes, who do not need pacing therapy. Few data are available on the percentage of patients with inherited arrhythmia syndromes eligible for S-ICD implantation. Aim of this study was to analyse the eligibility for S-ICD in a series of patients with Brugada syndrome (BrS), and to compare it with patients with other channelopathies., Methods and Results: Patients presenting with BrS, long-QT syndrome (LQTS), early repolarization syndrome (ERS), and idiopathic ventricular fibrillation (IVF) were considered eligible for this study. ECG screening was performed by analysis of QRS complex and T wave morphology recorded in standing and supine position. Eligibility was defined when ≥1 sense vector was acceptable in both supine and standing position. A total of 100 patients (72 males; mean age: 46 ± 17 years) underwent S-ICD sensing screening. Sixty-one patients presented with BrS, 21 with LQTS, 14 with IVF, and 4 with ERS. Thirty-four patients with BrS (56%) presented with spontaneous type 1 ECG. In the other 27 patients (44%), type 1 ECG was unmasked by ajmaline. Overall, rate of screening failure was 13%. Patients with BrS had a higher rate of inappropriate morphology analysis as compared with other channelopathies (18% vs. 5%, P = 0.07) and had a lower number of suitable sensing vectors (49.6% vs. 84.7% vs. P < 0.001). Ajmaline challenge unmasked sensing failure in 14.8% of drug-induced BrS patients previously considered eligible. In all patients, the reason for sensing inappropriateness was due to the presence of high T wave voltages., Conclusion: S-ICD screening failure occurs in up to 13% of patients with inherited primary arrhythmia syndromes. Patients with BrS present a higher rate of screening failure as compared with other cardiac channelopathies.

Background: In the major trials of cardiac resynchronization therapy (CRT), the survival benefit of the therapy, relative to control subjects, increases with QRS duration. In the non-CRT heart failure population, however, a wide QRS duration is associated with a shorter survival. Relative survival benefit from a therapy, however, is not synonymous with a longer absolute survival. We sought to determine whether baseline QRS duration relates to the absolute survival after CRT., Methods and Results: In this prospective, longitudinal, observational study, 3,319 consecutive patients undergoing CRT (QRS 120-149 ms 26%, QRS 150-199 ms 58%, and QRS ≥200 ms 16%) were assessed in relation to mortality over 10 years. Overall mortality rates (per 100 patient-years) were 9.2%, 9.3%, and 13.3% in the 3 groups, respectively (all P < .001). Cardiac mortality rates were 6.2, 6.0, and 9.9 per 100 patient-years, respectively (all P < .001). Compared with the QRS 120-149 ms group, cardiac mortality was highest in the QRS ≥200 ms group (hazard ratio [HR] 1.72 [95% CI 1.35-2.19], P < .001), independent of age, gender, New York Heart Association class, presence of atrial fibrillation, heart failure etiology, and left ventricular ejection fraction. Median survival after CRT was longest in patients with a width of QRS 120-149 ms and shortest in patients with a QRS ≥200 ms (P < .001). In multivariable analyses, a QRS ≥200 ms emerged as a powerful independent predictor of both overall (HR 1.44 [95% CI 1.07-1.94], P = .017) and cardiac mortality (HR 1.59 [95% CI 1.14-2.24], P = .007)., Conclusions: At long-term follow-up, absolute overall and cardiac survival after CRT is similar in patients with a preimplant QRS duration of 120 to 149 ms and 150 to 199 ms but markedly shorter in patients with a QRS ≥200 ms., (© 2014.)

Implantations of cardiac devices therapies and ablation procedures frequently depend on accurate and reliable imaging modalities for pre-procedural assessments, intra-procedural guidance, detection of complications, and the follow-up of patients. An understanding of echocardiography, cardiovascular magnetic resonance imaging, nuclear cardiology, X-ray computed tomography, positron emission tomography, and vascular ultrasound is indispensable for cardiologists, electrophysiologists as well as radiologists, and it is currently recommended that physicians should be trained in several imaging modalities. There are, however, no current guidelines or recommendations by electrophysiologists, cardiac imaging specialists, and radiologists, on the appropriate use of cardiovascular imaging for selected patient indications, which needs to be addressed. A Policy Conference on the use of imaging in electrophysiology and device management, with representatives from different expert areas of radiology and electrophysiology and commercial developers of imaging and device technologies, was therefore jointly organized by European Heart Rhythm Association (EHRA), the Council of Cardiovascular Imaging and the European Society of Cardiac Radiology (ESCR). The objectives were to assess the state of the level of evidence and a first step towards a consensus document for currently employed imaging techniques to guide future clinical use, to elucidate the issue of reimbursement structures and health economy, and finally to define the need for appropriate educational programmes to ensure clinical competence for electrophysiologists, imaging specialists, and radiologists.

We are in the midst of a rapidly evolving era of technology-assisted medicine. The field of telemedicine provides the opportunity for highly individualized medical management in a way that has never been possible before. Evolving medical technologies using cardiac implantable devices (CIEDs) with capabilities for remote monitoring permit evaluation of multiple parameters of cardiovascular physiology and risk, including cardiac rhythm, device function, blood pressure values, the presence of myocardial ischaemia, and the degree of compensation of congestive heart failure. Cardiac risk, device status, and response to therapies can now be assessed with these electronic systems of detection and reporting. This document reflects the extensive experience from investigators and innovators around the world who are shaping the evolution of this rapidly expanding field, focusing in particular on implantable pacemakers (IPGs), implantable cardioverter-defibrillators (ICDs), devices for cardiac resynchronization therapy (CRT) (both, with and without defibrillation properties), loop recorders, and haemodynamic monitoring devices. This document covers the basic methodologies, guidelines for their use, experience with existing applications, and the legal and reimbursement aspects associated with their use. To adequately cover this important emerging topic, the International Society for Holter and Noninvasive Electrocardiology (ISHNE) and the European Heart Rhythm Association (EHRA) combined their expertise in this field. We hope that the development of this field can contribute to improve care of our cardiovascular patients.

Aims: The European CRT Survey is a joint initiative of the Heart Failure Association (HFA) and the European Heart Rhythm Association (EHRA) of the European Society of Cardiology evaluating the contemporary implantation practice of cardiac resynchronization therapy (CRT) in Europe., Methods and Results: Patients who had a successful CRT implantation were enrolled from 141 centres in 13 countries between November 2008 and June 2009. Baseline demographics, clinical and implantation data were collected, with a follow-up of ∼1 year (9-15 months). The current report describes clinical outcomes including symptom severity, cardiovascular (CV) hospitalization, and survival. A total of 2438 patients were enrolled, and follow-up data were acquired from 2111 patients (87%). The population included important groups of patients poorly represented in randomized controlled trials, including very elderly patients and those with prior device implantation, atrial fibrillation, and/or QRS duration <120 ms. Investigators reported substantial improvement in New York Heart Association (NYHA) functional class at follow-up. Patient self-assessment indicated that 81% of the patients felt improved, 16% reported no change, and 4% reported deterioration. During follow-up, 207 (10%) patients died, 346 (16%) had a CV hospitalization, and 501 (24%) died or had CV hospitalization. Worse NYHA functional class, atrial fibrillation, ischaemic aetiology, and device type (CRT-P, i.e. CRT alone) were associated with poorer survival. Women had a better outcome, as did patients who had a CRT-D (with an implantable cardioverter defibrillator function) device., Conclusions: Outcomes including death and hospitalization in this European CRT survey were consistent with results from clinical trials of CRT. At 1 year follow-up, most patients who received a CRT device considered their symptoms improved compared with their pre-implant assessment. Although prospective, this is an observational study of successful CRT implantations, and outcomes in subgroup analyses must be interpreted with appropriate conservatism.

Aims: Cardiac resynchronization therapy (CRT) is an effective treatment for a subset of patients with chronic heart failure. Data on the benefit of CRT in heart failure patients with previous right ventricular pacemakers or standard defibrillators are sparse., Methods and Results: The European (HFA, Heart Failure Association/EHRA, European Heart Rhythm Association) CRT Survey enrolled patients from 141 centres in 13 countries in Europe collecting baseline demographic, echocardiographic, clinical, and implant data, with follow-up at ∼1 year. The present analysis reports implantation data and 1 year outcomes regarding New York Heart Association (NYHA) class, global patient assessment, hospitalizations, complications, and mortality in patients undergoing de novo CRT implantations compared with those receiving an upgrade of a previously implanted device (pacemaker or implantable cardioverter-defibrillators). This analysis includes 2367 CRT implant procedures of which 692 (28%) were upgrades to CRT. Distribution of NYHA functional class and left ventricular function were similar between the groups. Procedural duration was also similar, although fluoroscopy time was shorter in the 'upgrades'. There was no difference in the frequency of peri-procedural complications. There were similar improvements in NYHA functional class and similar reduction in QRS duration, but more patients reported unchanged global assessment status in the upgraded group. Total and cause-specific mortality at 1 year was low and the same in both groups., Conclusions: More than one quarter of all CRT procedures are upgrades from existing systems, although this group has not been subject to randomized clinical trials. Our data suggest that there are no significant differences in clinical outcomes or complication rates between upgrades and de novo procedures. Clinical study no NCT 01185392.

Heart failure , a syndrome associated with increasing prevalence, high mortality, and frequent hospital admissions, imposes a significant economic burden on western healthcare systems that is expected to further increase in the future due to the ageing population. Hospitalizations are responsible for the largest part of treatment costs and, thus, the main target for strategies aiming at cost reduction. Current literature suggests that evidence-based therapy with drugs, devices, and modern disease management programmes improves clinical outcomes of the large population of heart failure patients in a largely cost-effective manner. However, comprehensive knowledge about the cost of treatment is important to guide clinicians in the responsible allocation of today's limited health-care resources. This review provides information about the total cost of heart failure and the contribution of different treatment components to the overall costs.

This multicenter longitudinal observational trial was designed to analyze the long-term outcome of patients with heart failure (HF) treated with cardiac resynchronization therapy (CRT) alone or with implantable cardioverter-defibrillator (ICD) backup in a daily practice scenario. It is unknown whether the magnitude of survival benefits conferred by CRT in a daily practice scenario is comparable to what has been observed in randomized controlled trials and whether this benefit is sustained over the long term. The outcome of 1,303 consecutive patients with ischemic or nonischemic cardiomyopathy on optimal pharmacologic therapy treated from August 1, 1995 to August 1, 2004 at 4 European centers with CRT alone (44%) or with ICD backup for symptomatic HF and prolonged QRS duration was assessed. Cumulative event-free survival was evaluated for a combined end point, defined as death from any cause, urgent transplantation, or implantation of a left ventricular assist device. The cumulative incidence of competing events, HF, sudden cardiac death, and noncardiac death, was also assessed. Event-free survival was similar across the different centers. At 1 and 5 years, cumulative event-free survivals were 92% (95% confidence interval [CI] 91 to 94) and 56% (95% CI 48 to 64), respectively. The cumulative incidence of HF deaths was 25.1% (95% CI 19 to 31.7), whereas that of sudden death was 9.5% (95% CI 5.1 to 15.7). Using multivariate analysis, CRT with an ICD backup was associated with a nonsignificant decrease in mortality by 20% (hazard ratio 0.83, 95% CI 0.58 to 1.17, p = 0.284), with a highly significant protective effect against sudden cardiac death (hazard ratio 0.04, 95% CI 0.04 to 0.28, p <0.002). In conclusion, patients with advanced HF and a wide QRS complex routinely treated with CRT have a favorable long-term outcome that was reproducible at different centers. The leading cause of death in these patients remained HF, and this mode of death was competing with other causes in determining outcome. Total mortality was 20% lower with ICD backup (95% CI 42% lower to 17% higher) due to a protective effect against sudden cardiac death.

Objectives: We sought to determine whether radial left ventricular (LV) asynchrony in patients with heart failure predicts systolic function improvement with cardiac resynchronization therapy (CRT)., Background: We quantified LV wall motion by echocardiography to correlate the effects of CRT on LV systolic function with wall motion synchrony., Methods: Thirty-four patients underwent echocardiographic phase analysis of LV septal and lateral wall motion and hemodynamic testing before CRT. Phase relationships were measured by the difference between the lateral (Phi(L)) and septal (Phi(S)) wall motion phase angles: Phi(LS) = Phi(L) - Phi(S). The absolute value of Phi(LS) was used as an order-independent measure of synchrony: the absolute value Phi(LS) = the absolute value of Phi(L) - Phi(S)., Results: Three phase relationships were identified (mean +/- SD): type 1 (n = 4; peak positive LV pressure [dP/dt(max)] 692 +/- 310 mm Hg/s; Phi(LS) = 5 +/- 6 degrees, synchronous wall motion); type 2 (n = 17; dP/dt(max) 532 +/- 148 mm Hg/s; Phi(LS) = 77 +/- 33 degrees, delayed lateral wall motion); and type 3 (n = 13; dP/dt(max) 558 +/- 154 mm Hg/s; Phi(LS) = -115 +/- 33 degrees, delayed septal wall motion, triphasic). A large absolute value of Phi(LS) predicted a larger increase in dP/dt(max) with CRT (r = 0.74, p < 0.001). Sixteen patients were studied during right ventricular (RV), LV and biventricular (BV) pacing. Cardiac resynchronization therapy acutely reduced the absolute value of Phi(LS) from 104 +/- 41 degrees (OFF) to 86 +/- 45 degrees (RV; p = 0.14 vs. OFF), 71 +/- 50 degrees (LV; p = 0.001 vs. OFF) and 66 +/- 42 degrees (BV; p = 0.001 vs. OFF). A reduction in the absolute value of Phi(LS) predicted an improvement in dP/dt(max) in type 2 patients for LV (r = 0.87, p = 0.005) and BV CRT (r = 0.73, p = 0.04)., Conclusions: Echocardiographic quantification of LV asynchrony identifies patients likely to have improved systolic function with CRT. Improved synchrony is directly related to improved hemodynamic systolic function in type 2 patients.