BACKGROUND AND AIMS:Although use of the subcutaneous implantable cardioverter defibrillator (S-ICD) is increasing, evidence from industry-independent and unselected populations remains limited. METHODS:HONEST is a ongoing nationwide academic observational study enrolling 98.2% of patients implanted with an S-ICD across France (2012-2019). Five-year clinical endpoints were centrally adjudicated. RESULTS:Overall, 4924 patients were enrolled (mean age 49.9 ± 15 years, 76.7% male, 63.0% for primary prevention). Implants used general anaesthesia (78.9%), and defibrillation testing (82.6%). Perioperative complications (within 30 days) occurred in 4.4%. At 5 years, cumulative incidence rates were 13.8% for inappropriate shocks, 10.8% for early battery depletion, 2.4% for infections, 1.5% for lead dysfunction, and 1.4% for chronic discomfort. Reoperation was required in 16.9%, need for cardiac pacing in 3.1%, and definite S-ICD extraction in 8.4%. Inappropriate shocks were independently associated with male sex (hazard ratio [HR] 1.29, 95% confidence interval [CI] 1.14-1.46, P < .001), obesity (HR 1.35, 95% CI 1.02-1.79, P = .032), arrhythmogenic right ventricular cardiomyopathy (HR 1.70, 95% CI 1.03-2.81, P = .036), and the presence of a pacemaker (HR 2.20, 95% CI 1.16-4.17, P = .016). SMART Pass filtering significantly reduced inappropriate shocks (HR 0.67, 95% CI 0.50-0.89, P = .007). Among patients with inappropriate shocks, ∼1% developed induced ventricular fibrillation (one fatality), and 10% underwent device extraction. Ineffective shocks or undetected arrhythmias occurred in only 0.2%. Among 547 deaths (11.1%), 53.9% were cardiovascular, including 26 sudden deaths, and 8 were S-ICD/procedure-related, with none related to S-ICD extraction. CONCLUSIONS:This nationwide study refines the long-term event profile of S-ICD therapy and may inform clinical practice and device selection.
BACKGROUND:The subcutaneous implantable cardioverter-defibrillator (S-ICD) is an established therapy for sudden cardiac death prevention, but sex-specific outcomes remain incompletely characterized. OBJECTIVES:This study evaluated sex-related differences in baseline characteristics, appropriate shocks, complications, reinterventions, and mortality among S-ICD recipients. METHODS:The nationwide HONEST (S-ICD French Cohort Study) cohort enrolled all patients who received an S-ICD in France between 2012 and 2019. Clinical endpoints were centrally adjudicated. Sex-specific associations with outcomes were assessed by using propensity score-based inverse probability weighting. RESULTS:Among 4,924 S-ICD recipients, 1,148 were women (23.3%). Compared with men, women were younger (47.3 ± 15.6 years vs 50.6 ± 14.7 years; P < 0.001), less frequently received an implant for primary prevention (57.6% vs 65.1%; P < 0.001), less often had coronary artery disease (38.9% vs 56.5%; P < 0.001), and more often had electrical heart disease (26.3% vs 20.4%; P < 0.001). After adjustment, women had a lower 5-year risk of appropriate shocks (HR: 0.85; 95% CI: 0.74-0.98; P = 0.023) and similar overall complication and reintervention rates but a distinct complication profile, with higher risks of chronic pain (HR: 2.63; 95% CI: 1.61-4.29; P < 0.001) and lead dislodgment (HR: 1.79; 95% CI: 1.09-2.95; P = 0.022) and a lower risk of inappropriate shocks (HR: 0.64; 95% CI: 0.50-0.82; P < 0.001). All-cause mortality was lower in women, whereas S-ICD-unresponsive sudden death and device-related mortality were similar. CONCLUSIONS:Women receiving an S-ICD experienced fewer appropriate shocks, with similar overall complication and reintervention rates, but a distinct complication profile. These findings support sex-informed S-ICD selection and follow-up. (S-ICD French Cohort Study [HONEST]; NCT05302115).
AIMS:Leadless pacemakers (LLPs) offer a valuable option for selected patients requiring ventricular pacing. However, data on revision procedures-defined as any intervention on an implanted LLP to correct dysfunction or upgrade the system, with or without removal-remain scarce. This study aimed to evaluate the real-world incidence, characteristics, and outcomes of LLP revisions, with particular emphasis on the feasibility and safety of removal. METHODS AND RESULTS:This multicentre retrospective study involved 46 French centres performing LLP implantations between 2015 and 2023. Among 8994 Micra LLPs implanted, 100 revision procedures (1.1%) were performed in 100 patients, including 73 Micra VR and 27 Micra AV devices, at a median follow-up of 229 (68.5-629.8) days. Seventy revisions were managed without device removal, while 30 involved removal. Revision indications included device upgrade (55%), high pacing threshold (33%), battery depletion (3%), ventricular arrhythmias (3%), and miscellaneous causes (6%). No significant differences were observed in pacing indications, implantation characteristics, or initial device indication between the two groups. Revisions occurred significantly earlier in the removal group than in the group without removal [median 81.5 (8-211.5) days, vs. 334 (130.25-882.5) days, P < 0.001], with 80% occurring within 1 year. Device removal was successful in 97% of cases (one failure at 157 days of follow-up), with no major complications reported. CONCLUSION:LLP revisions are infrequent and predominantly managed without device removal. However, given the high procedural success rate and the low complication rate, device removal appears to be underutilized and should be considered more frequently on a case-by-case basis.
BACKGROUND:Prediction of outcomes remains an unmet need in candidates for LVADs. The development of right-heart failure portends an excess in mortality rates, but imaging parameters of right ventricular systolic function have failed to demonstrate a prognostic role. By integrating pulmonary pressure, right ventriculoarterial coupling could fill this gap. METHODS:The ASSIST-ICD registry was used to test right ventriculoarterial coupling as a surrogate parameter at implantation for the prediction of all-cause mortality. RESULTS:The ratio of the tricuspid annular-plane systolic excursion over the estimated systolic pulmonary pressure (TAPSE/sPAP) was not associated with long-term survival in univariate analysis (P = 0.89), nor was the pulmonary artery pulsatility index (PAPi) (P = 0.13). Conversely, the ratio of the right atrial pressure over the pulmonary capillary wedge pressure (RAP/PCWP) was associated with all-cause mortality (P < 0.01). After taking tricuspid regurgitation severity, LVAD indication, LVAD model, age, blood urea nitrogen levels, and pulmonary vascular resistance into account, RAP/PCWP remained associated with survival (HR 1.35 [1.10 - 1.65]; P < 0.01). CONCLUSION:Among pre-implant RVAC surrogates, only RAP/PCWP was associated with long-term all-cause mortality in LVAD recipients. This association was independent of established risk factors.
Abstract Background Without dedicated device, implantable cardioverter defibrillators (ICD) implantation in children is a real challenge for physicians. Types of implantation include transvenous, surgical and subcutaneous-ICD approach, but with a lack of reliable data comparing their respective efficacy and safety. Objective We here aim to compare the results of these 3 ICD implantation approaches in children. Methods Consecutive children (<16yo) implanted with an ICD from 2005 to 2021 in 19 french tertiary centers of the French Pediatric and Congenital heart disease network, were retrospectively enrolled in the study. The primary endpoints were the occurrence of lead failure, device infection or inappropriate shock. Results Among 306 patients (mean age 12,6 yo), 34% received a transvenous ICD, 28% a S-ICD and 38% a surgical ICD. During a median follow-up of 4.7 years, endpoints occurred in 24.2% of the total population, more often in the surgical group (p<0.05). After adjustment for age, ICD type and stratification by heart disease, there was an excess risk of lead failure or infection with the surgical ICD compared with the S-ICD (HR 7.54, 95% CI 1.73;32.91, p<0.05). However, when inappropriate shocks were included, the difference was reduced (HR 2.28, 95% CI 1.03;5.04, p>0.05). In addition, no significant difference between transvenous and surgical ICDs was observed in the multivariate analysis. Conclusions We demonstrate a high rate of complication in children implanted with an ICD. The transvenous and surgical approaches are quite similar. S-ICD appears as a promising approach with the lowest serious adverse event rate. Limitation of inappropriate shock remain the main challenge of this technique.Late complications
Background and Aims: Prophylactic implantable cardioverter-defibrillators (ICDs) are not recommended until left ventricular ejection fraction (LVEF) has been reassessed 40 to 90 days after an acute myocardial infarction. In the current therapeutic era, the prognosis of sustained ventricular arrhythmias (VAs) occurring during this early post-infarction phase (i.e. within 3 months of hospital discharge) has not yet been specifically evaluated in post-myocardial infarction patients with impaired LVEF. Such was the aim of this retrospective study. Methods: Data analysis was based on a nationwide registry of 1032 consecutive patients with LVEF <= 35% after acute myocardial infarction who were implanted with an ICD after being prescribed a wearable cardioverter-defibrillator (WCD) for a period of 3 months upon discharge from hospital after the index infarction. Results: ICDs were implanted either because a sustained VA occurred while on WCD (VA+/WCD, n = 72) or because LVEF remained <= 35% at the end of the early post-infarction phase (VA-/WCD, n = 960). The median follow-up was 30.9 months. Sustained VAs occurred within 1 year after ICD implantation in 22.2% and 3.5% of VA+/WCD and VA-/WCD patients, respectively (P < .0001). The adjusted multivariable analysis showed that sustained VAs while on WCD independently predicted recurrence of sustained VAs at 1 year (adjusted hazard ratio [HR] 6.91; 95% confidence interval [CI] 3.73-12.81; P < .0001) and at the end of follow-up (adjusted HR 3.86; 95% CI 2.37-6.30; P < .0001) as well as 1-year mortality (adjusted HR 2.86; 95% CI 1.28-6.39; P = .012). Conclusions: In patients with LVEF <= 35%, sustained VA during the early post-infarction phase is predictive of recurrent sustained VAs and 1-year mortality.
Prophylactic implantable cardioverter defibrillators (ICDs) are not recommended before reassessment of left ventricular ejection fraction (LVEF) between 40 and 90 days after an acute myocardial infarction (MI). However, little is known on the prognostic significance of sustained ventricular arrhythmias (S-VA) occurring during this "waiting period". To evaluate whether the occurrence of S-VA, successfully treated with a wearable cardioverter defibrillator (WCD) in the early post-MI phase, is associated with a higher subsequent risk of S-VA recurrence or death. We recruited a series of patients with an acute MI and a resulting LVEF ≤ 0.35, who were prescribed a WCD upon hospital discharge and who were subsequently implanted with an ICD either because sustained VT/VF occurred while on WCD (VA+/WCD) or because LVEF remained ≤ 0.35 after the post-MI "waiting period" (VA-/WCD). The primary endpoint was the occurrence of S-VA 1-year after ICD implantation. The study population consisted of 1032 consecutive patients (VA+/WCD: n = 72, VA-/WCD: n = 960) from 41 French centers. The median follow-up (FU) after ICD implantation was 2.6 years (interquartile range = 1.5–3.9). The primary endpoint was achieved in 16/72 (22.2%) and 34/959 (3.5%) of VA+/WCD and VA-/WCD patients, respectively (P < 0.0001) (Figure 1). Multivariate analysis was performed with adjustment for eleven risk factors for sudden cardiac death. S-VA on WCD independently predicted recurrence of S-VA at 1-year (adjusted-HR: 6.82; 95% CI: 3.68–12.66; P < 0.0001) and at the end of FU (adjusted-HR: 3.84; 95% CI: 2.36–6.26; P < 0.0001), as well as 1-year mortality (adjusted-HR: 2.84; 95% CI: 1.27–6.36; P = 0.012). The occurrence of S-VA on WCD in the early post-MI period is highly predictive of S-VA recurrence and early (1-year) mortality in patients with LVEF ≤ 0.35.
Background: An implantable loop recorder is an effective tool for diagnosing unexplained syncope. However, after a first episode in non-high-risk patients, the usefulness of implantable loop recorder implantation remains unclear. Aims: To analyse relevant risk factors for significant bradycardia in order to identify patients who do or do not benefit from implantable loop recorder implantation. Also, to study whether implantable loop recorder implantation with remote monitoring is associated with less recurrence of traumatic syncope. Methods: This was a retrospective monocentric study including patients with implantable loop recorder implantation after unexplained syncope, using remote monitoring and iterative consultations. Results: Two hundred and thirty-seven patients were implanted for unexplained syncope. Significant bradycardia occurred in 53 patients (22.4%): 23 (43.4%) caused by paroxysmal atrioventricular block and 30 (56.6%) caused by sinus node dysfunction, leading to permanent pacemaker implantation in 48 patients. Compared with younger patients, there was a 3.46-fold increase (95% confidence interval 1.92-6.23; P < 0.0001) in the risk of significant bradycardia in patients aged >= 60 years. Based on multivariable analysis, only "typical syncope" was associated with significant bradycardia occurrence (hazard ratio 3.14, 95% confidence interval 1.75-5.65; P = 0.0001). There was no recurrence of significant bradycardia with traumatic complications among patients implanted for traumatic syncope. Conclusions: This study shows that: (1) implantable loop recorders identify more significant bradycardia in patients aged >= 60 presenting with a first non-high-risk typical syncope, suggesting that an implantable loop recorder should be implanted after a first episode of unexplained syncope in such conditions; and (2) after traumatic syncope, implantable loop recorder implantation is safe, and is associated with little or no recurrence of traumatic syncope. (c) 2024 Elsevier Masson SAS. All rights reserved.
Abstract Funding Acknowledgements Type of funding sources: None. Background The implantable cardioverter defibrillator (ICD) lead is the most fragile part of the device. Several studies have focused on both the longevity of ICD and the factors associated with lead malfunction but long-term data (i.e., ≥ 10 years) are limited. Purpose We report our experience on the very long-term longevity of ICD leads. Methods Data from all patients ≥18 years implanted with an transvenous ICD at our university hospital between 1988 and May 2021 were prospectively collected and analyzed. Follow-up was censored in July 2022. Data included patient characteristics, lead characteristics and follow-up data. The primary endpoint of the study was the survival rate without lead failure defined by the 2017 HR consensus . Factors influencing longevity were analyzed. Results 2093 ICD leads were included in our study. During follow-up (mean = 72.6±56.9 months, range = 11-299), there were 84 lead dysfunction. Lead survival rate was 97% at 5 years, 92% at 10 years, 88% at 15 years and 85% at 24 years respectively. In the multivariate analysis, factors associated with a higher risk of lead dysfunction revealed were: younger age (p = 0.001), channelopathy (p = 0.037), Linox leads (p = 0.041), Riata leads (p = 0.022) and Fidelis leads (p = 0.001). On the other hand, polyurethane coated leads (p < 0.001), Durata leads (p = 0.036), Endotak reliance leads (p = 0.016) and Sprint quattro 6935 leads (p = 0.026) were associated with less lead dysfunction. Conclusion The survival rate of the leads decreased progressively between 1 and 24 years after implantation but the risk of lead rupture seems to be maximal within the first 10 years after implant with little increase thereafter.
Abstract 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
The presence of an implantable cardioverter-defibrillator (ICD) in the paediatric population is marked by the occurrence of more frequent complications compared to the adult population, such as lead failure, infections and inappropriate shocks. The objectives of the iChildren study is to carry out an inventory of French practices and to compare the three available defibrillation methods (endovascular, surgical, subcutaneous S-ICD) in terms of effectiveness and safety. We retrospectively included 274 children aged 16 years or younger at the time of the first implantation of an ICD, from most of the major French implanting centres since 2005. Data were collected in an eCRF. The primary composite outcome (PCO) associates the occurrence of lead failure or device infection. We also analyse the rate of appropriate and inappropriate shocks. An endovascular ICD was implanted in 103 patients (38%), a subcutaneous ICD (S-ICD) in 55 patients (20%), a surgical ICD in 116 patients (42%). During a mean follow-up time of 5.7 years, the occurrence of PCO was found in 21% of patients, 5% of the S-ICD patients, 19% of the endovascular patients, 29% of the surgical patients. In univariate analysis, the factors associated with PCO were: young age group, type of ICD. In multivariate analysis, after adjustment, the surgical ICD was associated with the highest risk of PCO (P < 0.05). In the total population, the rate of appropriate shocks was 30%, the rate of inappropriate shocks was 11%, with no statistically significant difference between ICD types at implantation. Surgical implantation of an ICD is associated with more long-term complications, such as lead failure and device infection. There was no statistically significant difference in the occurrence of inappropriate shocks between the 3 defibrillation approaches.
BACKGROUND Very few data have been published on the use of subcutaneous implantable cardioverter-defibrillators (S-ICDs) in patients with congenital heart disease (CHD). OBJECTIVES The aim of this study was to analyze outcomes associated with S-ICDs in patients with CHD. METHODS This nationwide French cohort including all patients with an S-ICD was initiated in 2020 by the French Institute of Health and Medical Research. Characteristics at implantation and outcomes were analyzed in patients with CHD. RESULTS From October 12, 2012, to December 31, 2019, among 4,924 patients receiving an S-ICD implant in 150 centers, 101 (2.1%) had CHD. Tetralogy of Fallot, univentricular heart, and dextro-transposition of the great arteries represented almost one-half of the population. Patients with CHD were significantly younger (age 37.1 +/- 15.4 years vs 50.1 +/- 14.9 years; P < 0.001), more frequently female (37.6% vs 23.0%; P < 0.001), more likely to receive an S-ICD for secondary prevention (72.3% vs 35.9%; P < 0.001), and less likely to have severe systolic dysfunction of the systemic ventricle (28.1% vs 53.1%; P < 0.001). Over a mean follow-up period of 1.9 years, 16 (15.8%) patients with CHD received at least 1 appropriate shock, with all shocks successfully terminating the ventricular arrhythmia. The crude risk of appropriate S-ICD shock was twice as high in patients with CHD compared with non-CHD patients (annual incidences of 9.0% vs 4.4%; HR: 2.1; 95% CI: 1.3-3.4); however, this association was no longer significant after propensity matching (especially considering S-ICD indication, P = 0.12). The burden of all complications (HR: 1.2; 95% CI: 0.7-2.1; P = 0.4) and inappropriate shocks (HR: 0.9; 95% CI: 0.4-2.0; P = 0.9) was comparable in both groups. CONCLUSIONS In this nationwide study, patients with CHD represented 2% of all S-ICD implantations. Our findings emphasize the effectiveness and safety of S-ICD in this particularly high-risk population. (S-ICD French Cohort Study [HONEST]; NCT05302115) (J Am Coll Cardiol 2023;82:590-599) (c) 2023 by the American College of Cardiology Foundation.
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. 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. 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). 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. NCT02323503.
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.
Abstract 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.
Background. - Despite guidelines describing the optimal diagnostic and therapeutic procedures for patients with suspected cardiac implantable electronic device (CIED) infections, their management is often challenging. Aims. - To describe our diagnostic and therapeutic practices for suspected CIED infection, and to compare them with European Heart Rhythm Association (EHRA) guidelines. Methods. - Patients hospitalized in the tertiary care Nancy University Hospital for suspected CIED infection from 2014 to 2019 were included retrospectively. We applied the EHRA classifi-cation of CIED infection, and compared diagnostic and therapeutic management with the EHRA guidelines. Results. - Among 184 patients (mean age 72.3 +/- 12.4 years), 137 had a proven infection of the lead (by transthoracic echocardiography/transoesophageal echocardiography, 18F-fluorodesoxyglucose positron emission tomography/computed tomography or positive culture of the lead) or an isolated pocket infection without proof of lead infection, and 47 had no proof of CIED infection. According to the EHRA classification, CIED infection was considered as definite in 145 patients and possible in 31 and was excluded in eight patients. Regarding recommended diagnostic procedures, blood cultures were performed in 90.8%, transthoracic echocardiogra-phy in 97.8%, transoesophageal echocardiography in 85.9%, 18F-fluorodesoxyglucose positron emission tomography/computed tomography in 50.5% and imaging for embolisms in 78.3% of the patients. Compared with therapeutic recommendations for the 145 cases of definite CIED infection, device removal was performed in 96 patients (66.2%) and antibiotic therapy was pre-scribed in 130 (89.7%), with a duration equal to or longer than that recommended in 105 (72.4%) of the patients. Conclusion. - This study underlines the difficulties in following theoretical guidelines in daily practice, where both technical and human considerations interfere with their strict appliance. (c) 2021 Elsevier Masson SAS. All rights reserved.
LVAD implantation in patients with a recently diagnosed cardiomyopathy has been poorly investigated. This work aims at describing the characteristics and outcomes of patients receiving a LVAD within 30 days following the diagnosis of cardiomyopathy. Patients from the ASSIST-ICD study was divided into recently and remotely diagnosed cardiomy-opathy based on the time from initial diagnosis of cardiomyopathy to LVAD implantation using the cut point of 30 days. The primary end point of the study was all-cause mortality at 30-day and during follow-up. A total of 652 patients were included and followed during a median time of 9.1 (2.5 to 22.1) months. In this population, 117 (17.9%) had a recently diagnosed cardiomyopathy and had LVAD implantation after a median time of 15.0 (9.0 to 24.0) days following the diagnosis. This group of patients was significantly younger, with more ischemic cardiomyopathy, more sudden cardiac arrest (SCA) events at the time of the diagnosis and were more likely to receive temporary mechanical support before LVAD compared with the remotely diagnosed group. Postoperative in-hospital survival was similar in groups, but recently diagnosed patients had a better long-term survival after hospital discharge. SCA before LVAD and any cardiac surgery combined with LVAD implantation were identified as 2 independent predictors of postoperative mortality in recently diagnosed patients. In conclusion, rescue LVAD implantation for recently diagnosed severe cardiomyopathy is common in clinical practice. Such patients experience a relatively low postoperative mortality and have a better long-term survival compared with remotely diagnosed patients. (C) 2021 Elsevier Inc. All rights reserved.
Abstract Aims We aimed to provide contemporary real-world data on wearable cardioverter-defibrillator (WCD) use, not only in terms of effectiveness and safety but also compliance and acceptability. Methods and results Across 88 French centres, the WEARIT-France study enrolled retrospectively patients who used the WCD between May 2014 and December 2016, and prospectively all patients equipped for WCD therapy between January 2017 and March 2018. All patients received systematic education session through a standardized programme across France at the time of initiation of WCD therapy and were systematically enrolled in the LifeVest Network remote services. Overall, 1157 patients were included (mean age 60 ± 12 years, 16% women; 46% prospectively): 82.1% with ischaemic cardiomyopathy, 10.3% after implantable cardioverter-defibrillator explant, and 7.6% before heart transplantation. Median WCD usage period was 62 (37–97) days. Median daily wear time of WCD was 23.4 (22.2–23.8) h. In multivariate analysis, younger age was associated with lower compliance [adjusted odds ratio (OR) 0.97, 95% confidence interval (CI) 0.95–0.99, P < 0.01]. A total of 18 participants (1.6%) received at least one appropriate shock, giving an incidence of appropriate therapy of 7.2 per 100 patient-years. Patient-response button allowed the shock to be aborted in 35.7% of well-tolerated sustained ventricular arrhythmias and in 95.4% of inappropriate ventricular arrhythmia detection, finally resulting in an inappropriate therapy in eight patients (0.7%). Conclusion Our real-life findings reinforce previous studies on the efficacy and safety of the WCD in the setting of transient high-risk group in selected patients. Moreover, they emphasize the fact that when prescribed appropriately, in concert with adequate patient education and dedicated follow-up using specific remote monitoring system, compliance with WCD is high and the device well-tolerated by the patient.