Dynamic changes in nocturnal heart rate predict short-term cardiovascular events in patients using the wearable cardioverter-defibrillator: from the WEARIT-France cohort study.

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.

Outcome of Temporary Circulatory Support As a Bridge-to-Left Ventricular Assist Device Strategy in Cardiogenic Shock Patients.

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.

Wearable cardioverter-defibrillator in patients with a transient risk of sudden cardiac death: the WEARIT-France cohort study.

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.

Implantable cardiac defibrillator leads dysfunction after LVAD implantation.

BACKGROUND: Implantable cardioverter-defibrillator (ICD) lead dysfunction has been reported after left ventricular assist device (LVAD) implantation in limited single-center studies. We aimed at describing and characterizing the incidence of ICD lead parameters dysfunction after LVAD implantation. METHODS: Among the 652 patients enrolled in the ASSIST-ICD study, only patients with an ICD prior to LVAD were included (n = 401). ICD lead parameters dysfunction following LVAD implantation is defined as follows: (a) >50% decrease in sensing threshold, (b) pacing lead impedance increase/decrease by >100Ω, and (c) >50% increase in pacing threshold. RESULTS: One hundred twenty-two patients with an ICD prior to LVAD had available ICD interrogation reports prior and after LVAD. A total of 67 (55%) patients exhibited at least one significant lead dysfunction: 17 (15%) exhibited >50% decrease in right ventricular (RV) sensing, 51 (42%) had >100 Ω increase/decrease in RV pacing impedance, and 24 (20%) experienced >50% increase in RV pacing threshold. A total of 52 patients experienced ventricular arrhythmia during follow-up and all were successfully detected and treated by the device. All lead dysfunction could be managed conservatively. CONCLUSION: More than 50% of LVAD-recipients may experience >1 significant change in lead parameters but none had severe clinical consequences.

Risk factors and prognostic impact of left ventricular assist device-associated infections.

BACKGROUND: Left ventricular assist device (LVAD)-associated infections may be life-threatening and impact patients' outcome. We aimed to identify the characteristics, risk factors, and prognosis of LVAD-associated infections. METHODS: Patients included in the ASSIST-ICD study (19 centers) were enrolled. The main outcome was the occurrence of LVAD-associated infection (driveline infection, pocket infection, or pump/cannula infection) during follow-up. RESULTS: Of the 652 patients enrolled, 201 (30.1%) presented a total of 248 LVAD infections diagnosed 6.5 months after implantation, including 171 (26.2%), 51 (7.8%), and 26 (4.0%) percutaneous driveline infection, pocket infection, or pump/cannula infection, respectively. Patients with infections were aged 58.7 years, and most received HeartMate II (82.1%) or HeartWare (13.4%). Most patients (62%) had implantable cardioverter-defibrillators (ICDs) before LVAD, and 104 (16.0%) had ICD implantation, extraction, or replacement after the LVAD surgery. Main pathogens found among the 248 infections were Staphylococcus aureus (n = 113' 45.4%), Enterobacteriaceae (n = 61; 24.6%), Pseudomonas aeruginosa (n = 34; 13.7%), coagulase-negative staphylococci (n = 13; 5.2%), and Candida species (n = 13; 5.2%). In multivariable analysis, HeartMate II (subhazard ratio, 1.56; 95% CI, 1.03 to 2.36; P = .031) and ICD-related procedures post-LVAD (subhazard ratio, 1.43; 95% CI, 1.03-1.98; P = .031) were significantly associated with LVAD infections. Infections had no detrimental impact on survival. CONCLUSIONS: Left ventricular assist device-associated infections affect one-third of LVAD recipients, mostly related to skin pathogens and gram-negative bacilli, with increased risk with HeartMate II as compared with HeartWare, and in patients who required ICD-related procedures post-LVAD. This is a plea to better select patients needing ICD implantation/replacement after LVAD implantation.

Decreased delivery of inappropriate shocks achieved by remote monitoring of ICD: a substudy of the ECOST trial.

INTRODUCTION: Inappropriate shocks remain a highly challenging complication of implantable cardioverter defibrillators (ICD). We examined whether automatic wireless remote monitoring (RM) of ICD, by providing early notifications of triggering events, lowers the incidence of inappropriate shocks. METHODS AND RESULTS: We studied 433 patients randomly assigned to RM (n = 221; active group) versus ambulatory follow-up (n = 212; control group). Patients in the active group were seen in the ambulatory department once a year, unless RM reported an event requiring an earlier ambulatory visit. Patients in the control group were seen in the ambulatory department every 6 months. The occurrence of first and further inappropriate shocks, and their causes in each group were compared. The characteristics of the study groups, including pharmaceutical regimens, were similar. Over a follow-up of 27 months, 5.0% of patients in the active group received ≥1 inappropriate shocks versus 10.4% in the control group (P = 0.03). A total of 28 inappropriate shocks were delivered in the active versus 283 in the control group. Shocks were triggered by supraventricular tachyarrhythmias (SVTA) in 48.5%, noise oversensing in 21.2%, T wave oversensing in 15.2%, and lead dysfunction in 15.2% of patients. The numbers of inappropriate shocks delivered per patient, triggered by SVTA and by lead dysfunction, were 74% and 98% lower, respectively, in the active than in the control group. CONCLUSION: RM was highly effective in the long-term prevention of inappropriate ICD shocks.

Atrial flutter or fibrillation is the most frequent and life-threatening arrhythmia in myotonic dystrophy.

BACKGROUND: Several arrhythmias were reported in myotonic dystrophy (MD). OBJECTIVES: To evaluate the prevalence of atrial fibrillation (AF) and atrial flutter (AFL) in MD and the clinical consequences. METHODS: One hundred sixty-one patients, mean age 41 ± 14 years, were referred for a type 1 MD. All patients were asymptomatic except four patients and followed during 5 ± 4 years. Electrocardiogram (ECG), echocardiography assessing left ventricular ejection fraction, and Holter monitoring were obtained and repeated. RESULTS: Twenty-seven patients (17%) presented sustained (>1 hour) AF (n = 15) or AFL (n = 12); two of them presented syncope-related 1/1 AFL. In one of them, 16 years of age, cardiac defibrillator was implanted for a diagnosis of ventricular tachycardia, but the true diagnosis was established after inappropriate shocks. AFL ablation was performed in five patients, but four developed AF. The other seven patients with AFL developed AF. During the follow-up, 22 patients died (14%) from cardiac and respiratory failure; eight patients with AF/AFL died (30%) while only 14 without AF/AFL died (10%; P < 0.01). Univariate analysis indicated that age >40 years (death: 48 ± 14 vs 40 ± 8 in alive patients), abnormal ECG, and occurrence of AF/AFL were significant factors of death. At multivariate analysis, AF at ECG (odds ratio: 3.12) and age >40 (odds ratio: 3.14) were the sole independent variables predicting death. CONCLUSIONS: AF and AFL were frequent in MD and increased mortality. AFL could present as 1/1 AFL with a poor tolerance and a risk of misdiagnosis despite frequent conduction disturbances. This arrhythmia could explain wide QRS tachycardia occurring in MD and interpreted as VT.

Influence of the mode of management of acute myocardial infarction on the inducibility of ventricular tachyarrhythmias with programmed ventricular stimulation after myocardial infarction.

BACKGROUND: Programmed ventricular stimulation (PVS) is a technique for screening patients at risk for ventricular tachycardia (VT) after myocardial infarction (MI), but the results might be difficult to interpret. OBJECTIVES: To investigate the results of PVS after MI, according to date of completion. METHODS: PVS results were interpreted according to the mode of MI management in 801 asymptomatic patients: 301 (group I) during the period 1982-1989, 315 (group II) during 1990-1999, and 185 (group III) during 2000-2010. The periods were chosen based on changes in MI management. Angiotensin-converting enzyme (ACE) inhibitors had been given since 1990; primary angioplasty was performed routinely since 2000. The PVS protocol was the same throughout the whole study period. RESULTS: Group III was older (61 +/- 11 years) than groups I (56 +/- 11) and II (58 +/- 11) (P < 0.002). Left ventricular ejection fraction (LVEF) was lower in group III (36.5 +/- 11%) than in groups I (44 +/- 15) and II (41 +/- 12) (P < 0.000). Monomorphic VT < 270 beats/min was induced as frequently in group III (28%) as in group II (22.5%) but more frequently than in group I (20%) (P < 0.03). Ventricular fibrillation and flutter (VF) was induced less frequently in group III (14%) than in groups I (28%) (P < 0.0004) and II (30%) (P < 0.0000). Low left ventricular ejection fraction (LVEF) and date of inclusion (before/after 2000) were predictors of VT or VF induction on multivariate analysis. CONCLUSIONS: Induction of non-specific arrhythmias (ventricular flutter and fibrillation) was less frequent than before 2000, despite the indication of PVS in patients with lower LVEF. This decrease could be due to the increased use of systematic primary angioplasty for MI since 2000.

Bradycardia risk stratification with implantable loop recorder after unexplained syncope.

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.

CRT-D replacement strategy: results of the BioCONTINUE study.

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.

Subcutaneous Implantable Cardioverter-Defibrillators in Patients With Congenital Heart Disease.

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).

Safety and efficacy of programming a high number of antitachycardia pacing attempts for fast ventricular tachycardia: a prospective study.

AIMS: Little is known about the optimal number of antitachycardia pacing (ATP) attempts to programme in the fast ventricular tachycardia (FVT) zone. We sought to analyse the long-term efficacy and safety of programming a high number of ATP attempts for FVTs. METHODS AND RESULTS: All patients receiving an implantable cardioverter/defibrillator (ICD) for coronary artery disease or dilated cardiomyopathy for primary and secondary prevention between 2000 and 2009 were prospectively included. Implantable cardioverter/defibrillators were programmed to deliver 10 ATP attempts for FVT cycle lengths (CLs) of 250-300 ms (200-240 b.p.m.) before shock delivery (5 bursts, then 5 ramps; 8-10 extrastimuli at 81-88% FVT CL; minimal pacing CL 180 ms). Among 770 patients included and followed for 40.6 ± 25.6 months, 137 (17.8%) experienced a total of 1839 FVTs, 1713 of which were ATP-terminated (unadjusted efficacy = 93.1%, adjusted = 81.7%), 106 ATP-accelerated (5.8%), and 20 ATP-resistant (1.1%). The majority of FVT episodes were successfully treated by one or two attempts (98.3%). However, patient-based analysis showed that 17 (12.4%), 8 (5.8%), and 5 patients (2.1%) had at least one episode treated by three or more, four or more, and five or more ATP attempts. The benefit of this strategy was reduced after five attempts. The majority of FVT episodes was asymptomatic and diagnosed at device interrogation during follow-up: syncope and pre-syncope occurred in only 0.2 and 0.4% of episodes, respectively. CONCLUSION: Programming a high number of ATP attempts (up to five ATP attempts) in the FVT zone is both safe and efficient and could prevent shocks in numerous ICD recipients.

Recall alerts in implantable cardioverter-defibrillator recipients: implications for patients and physicians.

BACKGROUNDS: Implantable cardioverter-defibrillator (ICD) malfunctions sometimes need recall. Despite the increasing number of device implantation, ICD recalls and advisories' impacts have been little studied. The aim of this study was to determine the rate of ICD generator advisory in our center and to examine its clinical and financial implication. METHODS: We analyzed weekly Food and Drug Administration (FDA) Enforcement Reports issued between January 2000 and December 2008 to identify all advisories involving ICD generators and leads. We performed a retrospective analysis of all implanted patients affected by an advisory in our Cardiology department. RESULTS: During the 8 years of the study period, 13 advisories were issued for generators and one for leads, leading to a total number of 278 of 1,051 (26.4%) device with recall alerts, divided into 196 generator failures and 82 lead failures. Premature generator replacement was performed in 11 patients, whereas nine patients underwent lead replacement. There was no major complications attributable to advisory device replacement, and minor complications occurred only in one patient (lead extraction failure). Recalls accounted for 593 extra outpatient visits with a mean number of 2.20 ± 2.19 per patient. The total estimated cost of the device advisories in our population was 334,528 €. CONCLUSIONS: ICD recalls and safety alerts frequently occur in ICD recipients and tend to increase in number and rate. Although potentially serious, they do not appear to be associated with substantial complications. Financial implications are important.

Adherence to diagnostic and therapeutic practice guidelines for suspected cardiac implantable electronic device infections.

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 classification 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 echocardiography 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 prescribed 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.

Predictors of Subcutaneous Implantable Cardioverter-Defibrillator Shocks and Prognostic Impact in Patients With Structural Heart Disease.

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.

Characteristics and outcome of ambulatory heart failure patients receiving a left ventricular assist device.

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.

Comparison of Outcomes and Mortality in Patients Having Left Ventricular Assist Device Implanted Early -vs- Late After Diagnosis of Cardiomyopathy.

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 cardiomyopathy 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.

Factors likely to affect the long-term results of ventricular stimulation after myocardial infarction.

BACKGROUND: The results of programmed ventricular stimulation (PVS) may change after myocardial infarction (MI). The objective was to study the factors that could predict the results of a second PVS. METHODS: Left ventricular ejection fraction (LVEF) and QRS duration were determined and PVS performed within 3 to 14 years of one another (mean 7.5+/-5) in 50 patients studied systematically between 1 and 3 months after acute MI. RESULTS: QRS duration increased from 120+/-23 ms to 132+/-29 (p 0.04). LVEF did not decrease significantly (36+/-12 % vs 37+/-13 %). Ventricular tachycardia with cycle length (CL) > 220ms (VT) was induced in 11 patients at PVS 1, who had inducible VT with a CL > 220 ms (8) or < 220 ms (ventricular flutter, VFl) (3) at PVS 2. VFl or fibrillation (VF) was induced in 14 patients at PVS 1 and remained inducible in 5; 5 patients had inducible VT and 4 had a negative 2nd PVS. 2. 25 patients had initially negative PVS; 7 had secondarily inducible VT, 4 a VFl/VF, 14 a negative PVS. Changes of PVS were related to initially increasing QRS duration and secondarily changes in LVEF and revascularization but not to the number of extrastimuli required to induce VFl. CONCLUSIONS: In patients without induced VT at first study, changes of PVS are possible during the life. Patients with initially long QRS duration and those who developed decreased LVEF are more at risk to have inducible monomorphic VT at 2nd study, than other patients.

Subcutaneous Implantable Cardioverter-Defibrillator Lead Extraction: First Multicenter French Experience.

OBJECTIVES: The aim of this multicenter study was to characterize the efficacy and safety of subcutaneous implantable cardioverter-defibrillators (S-ICDs) lead extraction procedures. BACKGROUND: S-ICDs have been developed to limit lead-related complications inherent to transvenous ICD devices. To date, no study has specifically investigated the safety and feasibility of S-ICD lead extraction procedures. METHODS: Patients requiring S-ICD lead extraction between February 1, 2014, and February 28, 2019, were retrospectively included in 10 centers. The primary endpoint of the study was procedural success, defined as the removal of all the lead and lead material from the subcutaneous space. Secondary endpoints included procedural complications and the need for specific extraction tools. RESULTS: S-ICD lead extraction procedures were performed in 32 patients (mean age 45.7 ± 13.8 years, 75.0% men, 65.6% in primary prevention). The median time from S-ICD lead implantation was 9.3 months (5.4 to 17.5 months). The primary endpoint, that is, complete removal of the material, was achieved in 96.9% of the patients, and only 1 procedural failure occurred (3.1%). Simple traction of the S-ICD lead was successful in 19 patients (59.4%), whereas 3 patients (9.4%) needed an additional incision and 9 patients (28.1%) required mechanical sheath to remove lead adhesions around the coil. No procedure-related complications occurred. Patients with successful simple traction extraction were implanted more recently (7.1 months [2.8 to 12.2 months] vs. 16.5 months [7.5 to 20.8 months]; p = 0.04) and had less prior history of sternotomy (2 [10.5%] vs. 5 [38.5%] patients; p = 0.09). CONCLUSIONS: S-ICD lead extraction is an efficient and safe procedure, but may require some specific tools like mechanical sheath, specifically when fibrotic adhesions developed around the parasternal coil.