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Introduction: We aimed to investigate the impact of the 2021 European Society of Cardiology (ESC) guideline changes in left bundle branch block (LBBB) definition on cardiac resynchronization therapy (CRT) patient selection and outcomes. Methods: The MUG (Maastricht, Utrecht, Groningen) registry, consisting of consecutive patients implanted with a CRT device between 2001 and 2015 was studied. For this study, patients with baseline sinus rhythm and QRS duration ≥ 130ms were eligible. Patients were classified according to ESC 2013 and 2021 guideline LBBB definitions and QRS duration. Endpoints were heart transplantation, LVAD implantation or mortality (HTx/LVAD/mortality) and echocardiographic response (LVESV reduction ≥15%). Results: The analyses included 1.202, typical CRT patients. The ESC 2021 definition resulted in considerably less LBBB diagnoses compared to the 2013 definition (31.6% vs. 80.9%, respectively). Applying the 2013 definition resulted in significant separation of the Kaplan–Meier curves of HTx/LVAD/mortality (p <.0001). A significantly higher echocardiographic response rate was found in the LBBB compared to the non‐LBBB group using the 2013 definition. These differences in HTx/LVAD/mortality and echocardiographic response were not found when applying the 2021 definition. Conclusion: The ESC 2021 LBBB definition leads to a considerably lower percentage of patients with baseline LBBB then the ESC 2013 definition. This does not lead to better differentiation of CRT responders, nor does this lead to a stronger association with clinical outcomes after CRT. In fact, stratification according to the 2021 definition is not associated with a difference in clinical or echocardiographic outcome, implying that the guideline changes may negatively influence CRT implantation practice with a weakened recommendation in patients that will benefit from CRT. [ABSTRACT FROM AUTHOR]

Aims: The European REMOTE-CIED study is the first randomized trial primarily designed to evaluate the effect of remote patient monitoring (RPM) on patient-reported outcomes in the first 2 years after implantation of an implantable cardioverter-defibrillator (ICD).Methods and Results: The sample consisted of 595 European heart failure patients implanted with an ICD compatible with the Boston Scientific LATITUDE® RPM system. Patients were randomized to RPM plus a yearly in-clinic ICD check-up vs. 3-6-month in-clinic check-ups alone. At five points during the 2-year follow-up, patients completed questionnaires including the Kansas City Cardiomyopathy Questionnaire and Florida Patient Acceptance Survey (FPAS) to assess their heart failure-specific health status and ICD acceptance, respectively. Information on clinical status was obtained from patients' medical records. Linear regression models were used to compare scores between groups over time. Intention-to-treat and per-protocol analyses showed no significant group differences in patients' health status and ICD acceptance (subscale) scores (all Ps > 0.05). Exploratory subgroup analyses indicated a temporary improvement in device acceptance (FPAS total score) at 6-month follow-up for secondary prophylactic in-clinic patients only (P < 0.001). No other significant subgroup differences were observed.Conclusion: Large clinical trials have indicated that RPM can safely and effectively replace most in-clinic check-ups of ICD patients. The REMOTE-CIED trial results show that patient-reported health status and ICD acceptance do not differ between patients on RPM and patients receiving in-clinic check-ups alone in the first 2 years after ICD implantation.ClinicalTrials.gov Identifier: NCT01691586. [ABSTRACT FROM AUTHOR]

Background: Patient satisfaction with remote patient monitoring (RPM) of implantable cardioverter defibrillators (ICDs) seems to be high, yet knowledge on long‐term patient experiences is limited. The European REMOTE‐CIED study explored patients' experiences with RPM, examined patient's preferences for ICD follow‐up, and identified determinants of patient's preferences in the first 2 years postimplantation. Methods: European heart failure patients (N = 300; median age = 66 years [interquartile range (IQR) = 59‐73], and 22% female) with a first‐time ICD received a Boston Scientific LATITUDE RPM system (Marlborough, MA, USA) and had scheduled in‐clinic follow‐ups once a year. Patients completed questionnaires at 1‐2 weeks and also at 3, 6, 12, and 24 months postimplantation and clinical data were obtained from their medical records. Patient evaluation data were analyzed descriptively, and Student's t‐tests/Man‐Whitney U tests or Chi‐square tests/Fisher's exact tests were performed to examine determinants of patient preferences. Results: At 2 years postimplantation, the median patient satisfaction score with the RPM system was 9 out of 10 (IQR = 8‐10), despite 53% of the patients experiencing issues (eg, failure to transmit data). Of the 221 patients who reported their follow‐up preferences, 43% preferred RPM and 19% preferred in‐clinic follow‐up. Patients with a preference for RPM were more likely to be higher educated (P = 0.04), employed (P = 0.04), and equipped with a new LATITUDE model (P = 0.04), but less likely to suffer from chronic obstructive pulmonary disease (P = 0.009). Conclusion: In general, patients were highly satisfied with RPM, but a subgroup preferred in‐clinic follow‐up. Therefore, physicians should include patients' concerns and preferences in the decision‐making process, to tailor device follow‐up to individual patients' needs and preferences. [ABSTRACT FROM AUTHOR]

Aims: The European REMOTE-CIED study is the first randomized trial primarily designed to evaluate the effect of remote patient monitoring (RPM) on patient-reported outcomes in the first 2 years after implantation of an implantable cardioverter-defibrillator (ICD)., Methods and Results: The sample consisted of 595 European heart failure patients implanted with an ICD compatible with the Boston Scientific LATITUDE® RPM system. Patients were randomized to RPM plus a yearly in-clinic ICD check-up vs. 3-6-month in-clinic check-ups alone. At five points during the 2-year follow-up, patients completed questionnaires including the Kansas City Cardiomyopathy Questionnaire and Florida Patient Acceptance Survey (FPAS) to assess their heart failure-specific health status and ICD acceptance, respectively. Information on clinical status was obtained from patients' medical records. Linear regression models were used to compare scores between groups over time. Intention-to-treat and per-protocol analyses showed no significant group differences in patients' health status and ICD acceptance (subscale) scores (all Ps > 0.05). Exploratory subgroup analyses indicated a temporary improvement in device acceptance (FPAS total score) at 6-month follow-up for secondary prophylactic in-clinic patients only (P < 0.001). No other significant subgroup differences were observed., Conclusion: Large clinical trials have indicated that RPM can safely and effectively replace most in-clinic check-ups of ICD patients. The REMOTE-CIED trial results show that patient-reported health status and ICD acceptance do not differ between patients on RPM and patients receiving in-clinic check-ups alone in the first 2 years after ICD implantation.ClinicalTrials.gov Identifier: NCT01691586., (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 to evaluate within the MADIT-CRT database whether different enrollment characteristics between US and non-US centres affected the clinical course of study patients., Methods and Results: We evaluated differences in baseline characteristics, procedure-associated complications, clinical as well as echocardiographic response to cardiac resynchronization therapy with a defibrillator (CRT-D), between patients enrolled in 87 US centres (n = 1271) and 23 non-US centres (n = 549) in MADIT-CRT. Non-US patients displayed significant differences in baseline characteristics from US patients, including a higher frequency of left bundle branch block, a more advanced heart failure (HF) functional class >3 months prior to enrollment, and larger baseline cardiac volumes. Procedure-related complications occurred at a significantly higher frequency among patients enrolled in non-US centres (17%) than among those enrolled in US centres (10%; P < 0.001). During follow-up, CRT-D was associated with 42% (P = 0.003) and 38% (P < 0.001) reductions in the risk of HF or death in the two respective groups (P for the difference = 0.80), and with similar reductions in cardiac volumes (all P > 0.10). Subgroup analysis showed a more pronounced effect of CRT-D among women in the US group, including a significant 71% (P = 0.02) reduction in the risk of death, whereas CRT-D therapy was associated with a significant clinical benefit in men only in the non-US group., Conclusion: Patients enrolled in US and non-US centres in MADIT-CRT displayed significant differences in baseline clinical and echocardiographic characteristics and in the frequency of procedure-related complications, but experienced an overall similar clinical and echocardiographic response to CRT-D.