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Background: In patients with cardiac resynchronization therapy defibrillators (CRT-Ds), the need for implantable cardioverter-defibrillator (ICD) back-up may be questionable at time of CRT-D replacement (REP) if ICD implant criteria are no longer met due to an improved left ventricular ejection fraction (LVEF) and if no major ventricular arrhythmic event (VAE) occurred during the CRT-D lifetime. The aim of our study was to assess the relevance of ICD back-up and predictors of VAE after REP in primary prevention CRT-D patients., Methods: The prospective, observational, international BioCONTINUE study investigated the rate of patients with at least 1 sustained VAE (sVAE) post-REP and searched for predictive factors of sVAE., Results: Two hundred seventy-six patients (70 ± 10 years, 77% men, mean LVEF 40.6 ± 12.6%) were followed for 28.4 ± 10.2 months. The rate of patients with sVAE was 8.3%, 10.3%, and 21.2% at 1, 2, and 4 years post-REP. Patients without persistent ICD indication at REP still had a sVAE rate of 5.7% (95% CI 2.3-11.5%) at 2 years. In multivariate analysis, predictive factors of subsequent sVAE were (i) persistent ICD indication (hazard ratio (HR) 3.6; 95% CI 1.6-8.3; p = 0.003); (ii) 64-72 years of age as compared to ≥ 79 years (HR 3.7; 95% CI 1.4-9.7; p = 0.008); and (iii) ischemic heart disease (HR 4.4; 95% CI 2.1-9.3; p < 0.0001)., Conclusions: The risk of sVAE (21.2% at 4 years post-REP) depends on age, ischemic heart disease, and ICD indication at the time of REP. A non-trivial risk of sVAE remains in patients without persistent ICD indication., Clinical Trial Registration: NCT02323503., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Aims: While elevated resting heart rate measured at a single point of time has been associated with cardiovascular outcomes, utility of continuous monitoring of nocturnal heart rate (NHR) has never been evaluated. We hypothesized that dynamic NHR changes may predict, at short term, impending cardiovascular events in patients equipped with a wearable cardioverter-defibrillator (WCD)., Methods and Results: The WEARIT-France prospective cohort study enrolled heart failure patients with WCD between 2014 and 2018. Night-time was defined as midnight to 7 a.m. NHR initial trajectories were classified into four categories based on mean NHR in the first week (High/Low) and NHR evolution over the second week (Up/Down) of WCD use. The primary endpoint was a composite of cardiovascular death and heart failure hospitalization. A total of 1013 [61 (interquartile range, IQR 53-68) years, 16% women, left ventricular ejection fraction 26% (IQR 22-30)] were included. During a median WCD wear duration of 68 (IQR 44-90) days, 58 patients (6%) experienced 69 events. After considering potential confounders, High-Up NHR trajectory was significantly associated with the primary endpoint compared to Low-Down [adjusted hazard ratio (HR) 6.08, 95% confidence interval (CI) 2.56-14.45, P < 0.001]. Additionally, a rise of >5 bpm in weekly average NHR from the preceding week was associated with 2.5 higher composite event risk (HR 2.51, 95% CI 1.22-5.18, P = 0.012) as well as total mortality (HR 11.21, 95% CI 3.55-35.37, P < 0.001) and cardiovascular hospitalization (HR 2.70, 95% CI 1.51-4.82, P < 0.001)., Conclusion: Dynamic monitoring of NHR may allow timely identification of impending cardiovascular events, with the potential for 'pre-emptive' action., Registration Number: Clinical Trials.gov Identifier: NCT03319160., Competing Interests: Conflict of interest: E.M. is consultant for ZOLL, Boston, Medtronic and received unrestricted grants from industrial partners (Medtronic, Abbott, Boston Scientific, Microport, Biotronik and ZOLL). R.G. have been compensated by ZOLL for giving presentations. The remaining authors have nothing to disclose., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Objectives: Temporary circulatory support (TCS) as a bridge-to-left ventricular assist device (BTL) in cardiogenic shock patients has been increasing, but limited data exists on this BTL strategy. We aimed at analyzing the outcome of BTL patients in a population of cardiogenic shock patients compared with those without TCS at the time of the left ventricular assist device (LVAD) surgery and identify predictors of postoperative mortality in this specific population., Design: A multicenter retrospective observational study conducted in 19 centers from 2006 to 2016., Setting: Nineteen French centers., Patients: A total of 329 cardiogenic shock patients at the time of LVAD implantation were analyzed. Patients were divided in three groups: those under TCS at the time of LVAD implantation (n = 173), those with TCS removal before LVAD surgery (n = 24), and those who did not undergo a bridging strategy (n = 152). Primary endpoint was 30-day mortality., Interventions: None., Measurements and Main Results: Among the BTL group, 68 (39.3%), 18 (10.4%), and 15 (8.7%) patients were under venoarterial extracorporeal membrane oxygenation, Impella, and IABP support alone, and 72 patients (20.6%) were under multiple TCS support. BTL patients presented similar 30 days survival compared with the TCS removal and non-BTL groups. However, BTL group had a significantly longer ICU duration stay, with two-fold duration of mechanical ventilation time, but the three groups experienced similar postoperative complications. Multivariate analysis identified three independent predictors of mortality in the BTL group: combined surgery with LVAD, body mass index (BMI), and heart failure (HF) duration. BTL strategy was not an independent predictor of mortality in cardiogenic shock patients who underwent LVAD., Conclusions: BTL strategy is not associated with a lower survival among cardiogenic shock patients with LVAD implantation. Predictors of mortality are combined surgery with LVAD, higher BMI, and HF duration., Competing Interests: Drs. Delmas and Gaudard received funding from Abiomed. Drs. Delmas and Blangy received funding from Abbott. Dr. Blangy received funding from Boston and Zoll. The remaining authors have disclosed that they do not have any potential conflicts of interest., (Copyright © 2022 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.)

Aims: Despite regularly updated guidelines, there is still a delay in referral of advanced heart failure patients to mechanical circulatory support and transplant centres. We aimed to analyse characteristics and outcome of non-inotrope-dependent patients implanted with a left ventricular assist device (LVAD)., Methods and Results: The ASSIST-ICD registry collected LVAD data in 19 centres in France between February 2006 and December 2016. We used data of patients in Interagency Registry for Mechanically Assisted Circulatory Support Classes 4-7. The primary endpoint was survival analysis. Predictors of mortality were searched with multivariable analyses. A total of 303 patients (mean age 61.0 ± 9.9 years, male sex 86.8%) were included in the present analysis. Ischaemic cardiomyopathy was the leading heart failure aetiology (64%), and bridge to transplantation was the main implantation strategy (56.1%). The overall likelihood of being alive while on LVAD support or having a transplant at 1, 2, 3, and 5 years was 66%, 61.7%, 58.7%, and 55.1%, respectively. Age [hazard ratio (HR) 1.03, 95% confidence interval (CI) 1.00-1.05; P = 0.02], a concomitant procedure (HR 2.32, 95% CI 1.52-3.53; P < 0.0001), and temporary mechanical right ventricular support during LVAD implantation (HR 2.94, 95% CI 1.49-5.77; P = 0.002) were the only independent variables associated with mortality. Heart failure medications before or after LVAD implantation were not associated with survival., Conclusion: Ambulatory heart failure patients displayed unsatisfactory survival rates after LVAD implantation. A better selection of patients who can benefit from LVAD may help improving outcomes., (© 2021 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Background: In this study we aimed to assess long-term outcomes in subcutaneous implantable cardioverter-defibrillator (S-ICD) recipients with structural heart disease by focussing especially on shock incidence, predictors, and associated prognoses., Methods: In this multicenter registry‒based study, we retrospectively included all patients who underwent S-ICD implantation at 3 tertiary centers. The prognostic impact of S-ICD shock was assessed with a composite outcome that included all-cause death and hospitalisation for heart failure., Results: A total of 351 patients with underlying cardiomyopathy were included in the investigation. Using multivariable Fine and Gray regression models, secondary prevention, left ventricular ejection fraction (LVEF), conditional shock threshold, and QRS duration appeared to be independent predictors of appropriate S-ICD shock occurrence. In the multivariate Cox regression model adjusted for age, baseline LVEF, underlying cardiomyopathy subtype, New York Heart Association class, and appropriate shocks were significantly associated with increased composite prognostic outcome risk (hazard ratio [HR], 2.61; 95% confidence interval [CI], 1.21-5.65; P = 0.014), whereas inappropriate shocks were not (HR, 1.35; 95% CI, 0.75-4.48; P = 0.18). The analysis of each component of the composite prognostic outcome highlighted that the occurrence of appropriate shocks was associated with an increased risk of hospitalisation for heart failure (HR, 3.10; 95% CI, 1.26-7.58; P = 0.013) and a trend for mortality (HR, 2.19; 95% CI, 0.78-6.16; P = 0.14)., Conclusions: Appropriate S-ICD shocks were associated with a 3-fold increase in acute heart failure admission, whereas inappropriate shocks were not. Conditional shock threshold programming is an independent predictor of S-ICD shock, and its prognostic impact should be investigated further in patients with structural heart disease., (Copyright © 2020 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Background: Left ventricular assist device (LVAD) implantation may be an attractive alternative therapeutic option for elderly patients with heart failure who are ineligible for heart transplantation., Aim: We aimed to describe the characteristics and outcomes of elderly patients (i.e. aged≥70 years) receiving an LVAD., Methods: This observational study was conducted in 19 centres between 2006 and 2016. Patients were divided into two groups-younger (aged<70 years) and elderly (aged≥70 years), based on age at time of LVAD implantation., Results: A total of 652 patients were included in the final analysis, and 74 patients (11.3%) were aged≥70 years at the time of LVAD implantation (maximal age 77.6 years). The proportion of elderly patients receiving an LVAD each year was constant, with a median of 10.6% (interquartile range 8.0-15.4%) per year, and all were implanted as destination therapy. Elderly and younger patients had similar durations of hospitalization in intensive care units and total lengths of hospital stays. Both age groups experienced similar rates of LVAD-related complications (i.e. stroke, bleeding, driveline infection and LVAD exchange), and the occurrence of LVAD complications did not impact survival in the elderly group compared with the younger group. Lastly, when compared with younger patients implanted as destination therapy, the elderly group also exhibited similar mid-term survival., Conclusion: This work strongly suggests that selected elderly adults can be scheduled for LVAD implantation., (Copyright © 2020 Elsevier Masson SAS. All rights reserved.)

Objectives: Our goal was to provide a picture of left ventricular assist device (LVAD) activity in France between 2007 and 2016 based on the multicentric ASSIST-ICD registry., Methods: We retrospectively collected 136 variables including in-hospital data, follow-up survival rates and adverse events from 671 LVAD recipients at 20 out of 24 LVAD implant centres in France. The average follow-up time was 1.2 years (standard deviation: 1.4); the total follow-up time was 807.5 patient-years., Results: The included devices were the HeartMate II®, HeartWare LVAS® or Jarvik 2000®. The overall likelihood of being alive while on LVAD support or having a transplant (primary end point) at 1, 2, 3 and 5 years postimplantation was 65.2%, 59.7%, 55.9% and 47.7%, respectively, given a cumulative incidence of 29.2% of receiving a transplant at year 5. At implantation, 21.5% of patients were on extracorporeal life support. The overall rate of cardiogenic shock at implantation was 53%. The major complications were driveline infection (26.1%), pump pocket or cannula infection (12.6%), LVAD thrombosis (12.2%), ischaemic (12.8%) or haemorrhagic stroke (5.4%; all strokes 18.2%), non-cerebral haemorrhage (9.1%) and LVAD exchange (5.2%). The primary end point (survival) was stratified by age at surgery and by the type of device used, with inference from baseline profiles. The primary end point combined with an absence of complications (secondary end point) was also stratified by device type., Conclusions: The ASSIST-ICD registry provides a real-life picture of LVAD use in 20 of the 24 implant centres in France. Despite older average age and a higher proportion of patients chosen for destination therapy, survival rates improved compared to those in previous national registry results. This LVAD registry contrasts with other international registries because patients with implants have more severe disease, and the national policy for graft attribution is distinct. We recommend referring patients for LVAD earlier and suggest a discussion of the optimal timing of a transplant for bridged patients (more dismal results after the second year of support?)., (© The Author(s) 2020. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Despite the increasingly high rate of implantation of pacemakers (PMs) and implantable cardioverter defibrillators (ICDs) in elderly patients, data supporting their clinical and cost-effectiveness in this age stratum are ambiguous and contradictory. We reviewed the data regarding the applicability, safety and effectiveness of conventional pacing, ICDs and cardiac resynchronization therapy (CRT) in elderly patients. Although periprocedural risk may be slightly higher in the elderly, the implantation procedure for PMs and ICDs is still relatively safe in this age group. In older patients with sinus node disease, the general consensus is that DDD pacing with the programming of an algorithm to minimize ventricular pacing is preferred. In very old patients presenting with intermittent or suspected atrioventricular block, VVI pacing may be appropriate. In terms of correcting potentially life-threatening arrhythmias, the effectiveness of ICD therapy is similar in older and younger individuals. However, the assumption of persistent ICD benefit in the elderly population is questionable, as any advantageous effect of the device on arrhythmic death may be attenuated by higher total non-arrhythmic mortality. While septuagenarians and octogenarians have higher annual all-cause mortality rates, ICD therapy may remain effective in selected patients at high risk of arrhythmic death and with minimum comorbidities despite advanced age. ICD implantation among the elderly, as a group, may not be cost-effective, but the procedure may reach cost-effectiveness in those expected to live more than 5-7years after implantation. Elderly patients usually experience significant functional improvement after CRT, similar to that observed in middle-aged patients. Management of CRT non-responders remains globally the same, while considering a less aggressive approach in terms of reinterventions (revision of left ventricular [LV] lead placement, addition of a right ventricular or LV lead, LV endocardial pacing configuration). Overall, physiological age, general status and comorbidities rather than chronological age per se should be the decisive factors in making a decision about device implantation selection for survival and well-being benefit in elderly patients., (Copyright © 2016 Elsevier Masson SAS. All rights reserved.)

Background: Defibrillation testing (DT) is usually performed during implantable cardioverter defibrillator (ICD) implantation., Aims: We conducted a multicentre prospective study to determine the DT procedures used in everyday practice, to compare the characteristics of patients with or without DT, and to compare severe adverse events in these two populations during implantation and follow-up., Methods: The LEADER registry enrolled 904 patients included for primo-implantation of a single (n=261), dual (n=230) or triple (n=429) defibrillation system in 42 French centres., Results: Baseline characteristics of patients (62.0 ± 13.5 years; 88% men; primary indication 62%) who underwent ventricular fibrillation (VF) induction (VF induction group, n=810) and those who did not (untested group, n=94, representing 10.4% of the entire study population) revealed that the untested group were older (P<0.01), had a lower left ventricular ejection fraction, a wider QRS complex and a higher New York Heart Association class and were more often implanted for primary prevention (P<0.001 for all). The main reason given for not performing ICD testing was poor haemodynamic condition (59/94). At 1 year, the cumulative survival rate was 95% in tested patients and 85% in untested patients (P<0.001), mainly because of heart failure deaths. There was one sudden cardiac death in the VF induction group and none in the untested group (P=1.000)., Conclusions: In this study, more than 10% of ICD patients were implanted without VF induction. Untested patients appeared to be sicker than tested patients, with a more severe long-term outcome, but without any difference in mortality due to arrhythmic events., (Copyright © 2013 Elsevier Masson SAS. All rights reserved.)

Biventricular resynchronization has been shown to be beneficial on morbidity and mortality in patients with symptomatic (NYHA class III or IV) systolic heart failure (left ventricular ejection fraction or LVEF is less or equal to 35%) under optimal medical treatment with electrical asynchrony (QRS > or = 120 ms) and in sinus rhythm. The purpose of this study was to evaluate the efficacy and safety of upgrading to biventricular resynchronization in paced patients presenting with symptomatic systolic heart failure. Over a period of eight years, 24 paced patients with symptomatic (class III or IV) systolic heart failure (LVEF < or =35%) with electrical asynchrony (QRS > or =160 ms) received an additional left ventricular pacing lead and a biventricular pulse generator. We compared the functional symptoms, QRS duration, LVEF, left ventricle telediastolic diameter and any aggravation or onset of ventricular arrhythmia before and after biventricular resynchronization. Biventricular resynchronization led to an improvement in dyspnea in 80% of cases (one or more class decrease on NHYA scale), a significant shortening in QRS duration (-40 ms, p < 0.05), a significant improvement in left ventricular dilation (-4 mm, p < 0.05) and a significant improvement in the ejection fraction (+4%, p < 0.05). This study showed that in paced patients presenting with cardiac failure and systolic dysfunction refractory to medical treatment, upgrading from a conventional pacing system to a biventricular pacemaker leads to a significant improvement in functional symptoms.

Aims While elevated resting heart rate measured at a single point of time has been associated with cardiovascular outcomes, utility of continuous monitoring of nocturnal heart rate (NHR) has never been evaluated. We hypothesized that dynamic NHR changes may predict, at short term, impending cardiovascular events in patients equipped with a wearable cardioverter-defibrillator (WCD). Methods and results The WEARIT-France prospective cohort study enrolled heart failure patients with WCD between 2014 and 2018. Night-time was defined as midnight to 7 a.m. NHR initial trajectories were classified into four categories based on mean NHR in the first week (High/Low) and NHR evolution over the second week (Up/Down) of WCD use. The primary endpoint was a composite of cardiovascular death and heart failure hospitalization. A total of 1013 [61 (interquartile range, IQR 53–68) years, 16% women, left ventricular ejection fraction 26% (IQR 22–30)] were included. During a median WCD wear duration of 68 (IQR 44–90) days, 58 patients (6%) experienced 69 events. After considering potential confounders, High-Up NHR trajectory was significantly associated with the primary endpoint compared to Low-Down [adjusted hazard ratio (HR) 6.08, 95% confidence interval (CI) 2.56–14.45, P < 0.001]. Additionally, a rise of >5 bpm in weekly average NHR from the preceding week was associated with 2.5 higher composite event risk (HR 2.51, 95% CI 1.22–5.18, P = 0.012) as well as total mortality (HR 11.21, 95% CI 3.55–35.37, P < 0.001) and cardiovascular hospitalization (HR 2.70, 95% CI 1.51–4.82, P < 0.001). Conclusion Dynamic monitoring of NHR may allow timely identification of impending cardiovascular events, with the potential for 'pre-emptive' action. Registration number Clinical Trials.gov Identifier: NCT03319160 [ABSTRACT FROM AUTHOR]

Background: The survival of patients with idiopathic dilated cardiomyopathy (IDCM) at III and IV stages of New York Heart Association (NYHA) is decreased in those with a bundle branch block (BBB) compared to those without BBB. Less is known on the prognosis of patients at earlier stages of NYHA and who had a left BBB (LBBB) or right BBB (RBBB). We sought to evaluate the prevalence and the clinical significance of LBBB or RBBB in patients with IDCM and classes I and II of NYHA. Methods: Clinical data, noninvasive, and invasive studies were consecutively collected in 310 patients, with IDCM, followed up to 4.8± 3.7 years. Results: Seventy-six patients (25%) had LBBB, 21 (7%) had RBBB, and 212 had no BBB. Patients with BBB were older than other patients (P < 0.009). Left ventricular ejection fraction (LVEF) was lower in LBBB than in RBBB and other patients (P < 0.05). Syncope was more frequent in BBB than in absence (P < 0.05). Incidence of spontaneous ventricular tachycardia (VT) and atrial fibrillation, VT induction, total cardiac events, and sudden death were similar in the presence or absence of BBB. Deaths by heart failure and heart transplantations tended to be more frequent in BBB than in absence. Conclusions: LBBB was present in 25% of patients with IDCM; RBBB was rare. Patients with BBB were older and had more frequent syncope than patients without BBB; LVEF was lower in LBBB than in RBBB or in absence of BBB. BBB did not increase the risk of spontaneous VT, VT induction, or sudden death, and tended to increase deaths by heart failure and the indications of heart transplantation. [ABSTRACT FROM AUTHOR]