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Summary 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.

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.

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.We aimed to describe the characteristics and outcomes of elderly patients (i.e. aged≥70 years) receiving an LVAD.This observational study was conducted in 19 centres between 2006 and 2016. Patients were divided into two groups-younger (aged70 years) and elderly (aged≥70 years), based on age at time of LVAD implantation.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.This work strongly suggests that selected elderly adults can be scheduled for LVAD implantation.

Background: Tetralogy of Fallot (TOF) is the most common cyanotic congenital heart disease, and sudden cardiac death represents an important mode of death in these patients. Data evaluating the implantable cardioverter defibrillator (ICD) in this patient population remain scarce. Methods: A Nationwide French Registry including all patients with tetralogy of Fallot with an ICD was initiated in 2010 by the French Institute of Health and Medical Research. The primary time to event end point was the time from ICD implantation to first appropriate ICD therapy. Secondary outcomes included ICD-related complications, heart transplantation, and death. Clinical events were centrally adjudicated by a blinded committee. Results: A total of 165 patients (mean age, 42.2±13.3 years, 70.1% males) were included from 40 centers, including 104 (63.0%) in secondary prevention. During a median (interquartile range) follow-up of 6.8 (2.5–11.4) years, 78 (47.3%) patients received at least 1 appropriate ICD therapy. The annual incidence of the primary outcome was 10.5% (7.1% and 12.5% in primary and secondary prevention, respectively; P =0.03). Overall, 71 (43.0%) patients presented with at least 1 ICD complication, including inappropriate shocks in 42 (25.5%) patients and lead dysfunction in 36 (21.8%) patients. Among 61 (37.0%) patients in primary prevention, the annual rate of appropriate ICD therapies was 4.1%, 5.3%, 9.5%, and 13.3% in patients with, respectively, 0, 1, 2, or ≥3 guidelines-recommended risk factors. QRS fragmentation was the only independent predictor of appropriate ICD therapies (hazard ratio, 3.47 [95% CI, 1.19–10.11]), and its integration in a model with current criteria increased the 5-year time-dependent area under the curve from 0.68 to 0.81 ( P =0.006). Patients with congestive heart failure or reduced left ventricular ejection fraction had a higher risk of nonarrhythmic death or heart transplantation (hazard ratio, 11.01 [95% CI, 2.96–40.95]). Conclusions: Patients with tetralogy of Fallot and an ICD experience high rates of appropriate therapies, including those implanted in primary prevention. The considerable long-term burden of ICD-related complications, however, underlines the need for careful candidate selection. A combination of easy-to-use criteria including QRS fragmentation might improve risk stratification. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03837574.

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.

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?).

International audience; 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.

Background Despite guidelines describing the optimal diagnostic and therapeutic procedures of patients with suspected infection of cardiac implantable electronic device (CIED), the management of such patients is often challenging. Purpose The aim of this study was to describe our diagnostic and therapeutic practices for suspected CIED infection and to compare them to European Heart Rhythm Association (EHRA) guidelines. Methods Patients hospitalized in our tertiary care hospital for suspected CIED infection from 2014 to 2019 were retrospectively included. We applied the EHRA classification and compared diagnostic and therapeutic management to EHRA guidelines. Results Among 184 patients (mean age 72.3±12.4 years), 137 had a proven infection of the lead (either by TTE/TEE, by [18F]FDG PET/CT, or by positive culture of the lead) or an isolated pocket infection without proof of lead infection and 47 had no proof of infection of CIED. According to EHRA classification, CIED infection was considered as definite in 145 patients, possible in 31 and excluded in 8. Regarding recommended diagnostic procedures, blood cultures were performed in 90.8%, TTE in 97.8%, TEE in 85.9%, [18F]FDG PET/CT in 50.5% and imaging for embolisms in 78.3% of the patients. Compared to therapeutic recommendations for the 145 cases of definite CIED infection, device removal was performed in 96 patients (66.2%), antibiotic therapy was prescribed in 130 (89.7%), with a duration equal or superior to the one recommended in 105 (72.4%) of the patients. One-year survival rate was 66.3% and was better in patients with device removal than in patients without, both in the whole population (respectively 77.7% and 48.6%) and in the patients with definite CIED infection (80.0% vs 49.0%). After adjustement on age and Charlson's score, patients without device removal had a significantly higher risk of 1-year mortality (HR=3.40 [1.84–6.26], p=0.0001). Conclusion Suspicion of CIED infection are difficult situations. The use of theoretical classification helps to define the different types of cases and the resultant therapeutic approach. In daily practice, our study shows that the strict adherence to these guidelines is not always possible. This study shows a relatively good use of diagnostic procedures. However, theoretical advice for medical therapy and removal procedures are not always properly followed. To improve patients' prognosis, infected device removal must be systematically discussed in multidisciplinary endocarditis team, weighing the benefit-risk ratio of the strict appliance of the guidelines. Funding Acknowledgement Type of funding sources: None. Diagnostic comparisonTherapeutic comparison

International audience

International audience; 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.

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.

International audience; The impact of uncommon etiology cardiomyopathies on Left-ventricular assist device (LVAD)-recipient outcomes is not very well known. This study aimed to characterize patients with uncommon cardiomyopathy etiologies and examine the outcomes between uncommon and ischemic/idiopathic dilated cardiomyopathy. This observational study was conducted in 19 centers between 2006 and 2016. Baseline characteristics and outcomes of patients with uncommon etiology were compared to patients with idiopathic dilated/ischemic cardiomyopathies. Among 652 LVAD-recipients included, a total of 590 (90.5%) patients were classified as ischemic/idiopathic and 62 (9.5%) patients were classified in the "uncommon etiologies" group. Main uncommon etiologies were: hypertrophic (n = 12(19%)); cancer therapeutics-related cardiac dysfunction (CTRCD) (n = 12(19%)); myocarditis (n = 11(18%)); valvulopathy (n = 9(15%)) and others (n = 18(29%)). Patients with uncommon etiologies were significantly younger with more female and presented less co-morbidities. Additionally, patients with uncommon cardiomyopathies were less implanted as destination therapy compared with ischemic/idiopathic group (29% vs 38.8%). During a follow-up period of 9.1 months, both groups experienced similar survival. However, subgroup of hypertrophic/valvular cardiomyopathies and CTRCD had significantly higher mortality compared to the ischemic/idiopathic or myocarditis/others cardiomyopathies. Conversely, patients with myocarditis/others etiologies experienced a better survival. Indeed, the 12-months survival in the myocarditis/others; ischemic/idiopathic and hypertrophic/CTRCD/valvulopathy group were 77%; 65%, and 46% respectively. In conclusion, LVAD-recipients with hypertrophic cardiomyopathy, valvular heart disease and CTRCD experienced the higher mortality rate.

The aim of this multicenter study was to characterize the efficacy and safety of subcutaneous implantable cardioverter-defibrillators (S-ICDs) lead extraction procedures.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.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.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).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.

Summary Background As the number of transcatheter aortic valve implantation (TAVI) procedures is constantly increasing, it is important to consider common complications, such as pacemaker (PM) implantation, and their specific risk factors. Aims Echocardiographic, computed tomography and electrocardiographic data were analysed to determine the predicting factors, if any, associated with PM implantation. Methods This retrospective study included patients referred to Nancy University Hospital for a TAVI procedure from January 2013 to December 2015. Both Medtronic CoreValve and Edwards SAPIEN valves were implanted. Patients with preprocedurally implanted PMs and/or referred from another institution were excluded. Results Of 208 TAVI patients, 23 had a pre-existing PM and were excluded. A new PM was required in 38 patients (20.5%). Pre-existing right bundle branch block (RBBB), the use of the Medtronic CoreValve and large prostheses were identified as predictors of PM implantation (P = 0.0361, P = 0.0004 and P = 0.0019, respectively). Using logistic regression, predictors of PM implantation included first-degree atrioventricular block (odds ratio 3.7, 95% confidence interval 1.5–9.1; P = 0.0054) and large aortic annulus diameter in echocardiography (odds ratio 1.2, 95% confidence interval 1–1.4; P = 0.0447), with a threshold of 24.1 mm. For the combination of preTAVI PR duration > 220 ms and QRS duration > 120 ms, the positive predictive value for PM implantation reached 80%. Conclusion Use of the Medtronic CoreValve, RBBB and first-degree atrioventricular block are major risk factors for post-TAVI PM implantation. In addition, large aortic annulus and large valvular prosthesis are independent risk factors for PM implantation. The combination of preTAVI prolonged PR interval and increased QRS duration could be used as a marker for periprocedural PM implantation.

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.

International audience; Objectives - This study aimed to evaluate incidence, clinical significance, and predictors of early ventricular arrhythmias (VAs) in left ventricular assist device (LVAD) recipients. Background - LVAD implantation is increasingly used in patients with end-stage heart failure. Early VAs may occur during the 30-day post-operative period, but many questions remain unanswered regarding their incidence and clinical impact. Methods - This observational study was conducted in 19 centers between 2006 and 2016. Early VAs were defined as sustained ventricular tachycardia and/or ventricular fibrillation occurring

International audience; 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.

International audience; 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.

International audience; Objectives - This study aimed to evaluate the incidence, clinical impact, and predictors of late ventricular arrhythmias (VAs) in left ventricular assist device (LVAD) recipients aiming to clarify implantable cardioverter-defibrillator (ICD) indications. Background - The arrhythmic risk and need for ICD in patients implanted with an LVAD are not very well known. Methods - This observational study was conducted in 19 centers between 2006 and 2016. Late VAs were defined as sustained ventricular tachycardia or fibrillation occurring >30 days post-LVAD implantation, without acute reversible cause and requiring appropriate ICD therapy, external electrical shock, or medical therapy. Results - Among 659 LVAD recipients, 494 (median 58.9 years of age; mean left ventricular ejection fraction 20.7 ± 7.4%; 73.1% HeartMate II, 18.6% HeartWare, 8.3% Jarvik 2000) were discharged alive from hospital and included in the final analysis. Late VAs occurred in 133 (26.9%) patients. Multivariable analysis identified 6 independent predictors of late VAs: VAs before LVAD implantation, atrial fibrillation before LVAD implantation, idiopathic etiology of the cardiomyopathy, heart failure duration >12 months, early VAs (

International audience

Inappropriate Shocks Reduction by Remote ICD Monitoring 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.

Background Managing conduction disturbances after transcatheter aortic valve implantation (TAVI) remains challenging. Predicting factors of permanent pacemaker (PPM) implantation have been studied but there are scarce data about the type and the long term TAVI induced conduction disturbances. Purpose This work aimed to specifically assess each conduction disturbance after TAVI, their incidence and evolution, to improve their management in indication and delay of PPM implantation. Methods This retrospective study included all patients undergoing TAVI at Nancy University Hospital from 2009 to 2016. Patients were followed over 1 year after procedure, with an electrocardiographic control at 3 and 12 months and a device control when implanted with a PPM. Results A total of 505 TAVI procedures were realized, with a 16.2% PPM implantation rate. Left bundle branch block occurrence (26.9%) seems insufficient to implant a PPM early (at 3 months 53.4% had disappeared, there was no PPM dependency and low ventricular pacing rates; non-implanted patients had good outcomes at 1 year) and should only extend duration of monitoring (34.1% developed a high-degree block, during the first 7 days). Per-procedural high-degree atrioventricular (AV) block should lead to an early PPM implantation when persisting after the procedure day (PPM controls confirmed high ventricular pacing rates), but lead to a conservative approach otherwise (10.3% risk of recurrence during hospitalization, no risk after discharge). Post-procedural transient complete AV block is associated with good outcomes since only 7.1% were PPM-dependent at 3 months and 30.8% had a ventricular pacing rate Conclusion Specific situations of conduction disturbance lead to different prognosis and should be managed specifically. After 3 months most of patients implanted with PPM have recovered a spontaneous AV conduction, with a low ventricular pacing rate.

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 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.

International audience; Despite the increasingly high rate of implantation of pacemakers (PM) and cardioverter-defibrillators (ICD) 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 the conventional pacing, ICD and cardiac resynchronization therapy (CRT) in elderly patients. Although peri-procedural risk may be slightly higher in the elderly, the procedure of implantation of PMs and ICDs is still relatively safe in this age group. In older patients with sinus node disease, a general consensus is that dual chamber pacing, along with the programming of an algorithm to minimise ventricular pacing is preferred. In very old patients presenting with intermittent or suspected AV block, VVI pacing may be appropriate. In terms of correcting potentially life-threatening arrhythmias, the effectiveness of ICD therapy is comparable in older and younger individuals. However, the assumption of persistent ICD benefit in the elderly population is questionable, as any advantage of the device on arrhythmic death may be attenuated by a 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 >5-7 years after implantation. The elderly patients usually experience a 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 re interventions (revision of LV lead placement, addition of a RV or LV lead, LV endocardial pacing configuration). Overall, age, comorbidities and comprehensive geriatric assessment should be the decisive factor in making a decision on device implantation selection for survival and well-being benefit in elderly patients.

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.

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. (PACE 2011; 96–103)

Multiple mechanisms can explain a tachycardia associated or not with a heart disease. It is important to establish its origin, particularly if advanced heart disease is present, for the treatment. Complete electrophysiological study remains an important means of diagnosis. We report the case of a 39-year old man, who had a dilated cardiomyopathy since the age of 25 years and who complained of tachycardia. These symptoms were shown to be related to atrioventricular nodal re-entrant tachycardia at electrophysiological study and a specific treatment was indicated.

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.Clinical data, noninvasive, and invasive studies were consecutively collected in 310 patients, with IDCM, followed up to 4.8+/-3.7 years.Seventy-six patients (25%) had LBBB, 21 (7%) had RBBB, and 212 had no BBB. Patients with BBB were older than other patients (P0.009). Left ventricular ejection fraction (LVEF) was lower in LBBB than in RBBB and other patients (P0.05). Syncope was more frequent in BBB than in absence (P0.05). 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.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.

The risk of infective endocarditis on pacemaker or ICD is not negligible and has increased in recent years. Several host-related, procedure-related, or device-related risk factors have been recognized. Owing to its potential severity, the possibility of infective endocarditis should be envisaged in patients with repeated pulmonary infections or documented bacteremia and transesophageal echocardiography should then be used. The most common germs causing pacemaker endocarditis are staphylococci. Treatment requires prolonged antibiotic therapy and retrieval of the pacemaker and leads.

Resume La signification de la fibrillation auriculaire (FA) dans la cardiomyopathie dilatee primitive (CMD) reste discutee. Le but de l'etude a ete d'evaluer les donnees cliniques, electrophysiologiques et pronostiques de patients ayant une CMD et une FA permanente en comparaison avec des sujets en rythme sinusal. Methodes Trois cent vingt-trois patients ayant une CMD primitive et une fraction d'ejection du ventricule gauche (FEVG) inferieure a 40 % ont ete hospitalises pour des tachycardies ventriculaires (TV) ( n = 69), des syncopes ( n = 103) ou des TV non soutenues sur l'enregistrement Holter ( n = 151). 65 etaient en FA permanente (groupe I), les autres en rythme sinusal (groupe II). Un enregistrement Holter, une mesure de la FEVG et une etude electrophysiologique ont ete realises. Les patients ont ete suivis pendant 3 ± 2 ans. Resultats Les patients du groupe I sont plus souvent des hommes et sont plus vieux que ceux du groupe II (61 ± 8 vs 52 ± 12 ans). Les syncopes (31 vs 36 %), les TV soutenues spontanees (18 vs 23 %), la FEVG (28 ± 9 vs 29 ± 9 %) et l'induction d'une TV (25 vs 35 %) sont similaires dans les deux groupes. Il n'y a pas de difference significative quant aux risques de mort subite (1,5 vs 5 %), de deces lies a une insuffisance cardiaque (5 vs 7 %) ou de transplantation cardiaque (8 vs 3 %). Conclusion Les patients avec CMD primitive et FA permanente sont plus âges que ceux en rythme sinusal. Les autres donnees cliniques, electrophysiologiques et pronostiques ne sont pas affectees par la FA.

The purpose of this study was to determine the factors associated with the induction of ventricular flutter/fibrillation (VFl/VF)and its prognostic significance in post-myocardial infarction.Programmed ventricular stimulation was performed after myocardial infarction (MI) for syncope (n = 232) or systematically (n = 755); 230 patients had an induced VFl/VF and were followed during 4 +/- 2 years.VFl/VF was induced in 49/232 patients (21%) with syncope versus 181/755 asymptomatic patients (24%) (NS) and 94/410 patients (23%) with left ventricular ejection fraction (LVEF)40% versus 136/577 patients (22.5%) with LVEF40% (NS). Cardiac mortality was 9%; LVEF was 33 +/- 15% in patients who died, 43 +/- 13% in alive patients (P0.004). In patients with LVEF40%, induced VFl/VF, mortality rate was 31% in those with syncope, 10% in asymptomatic patients (P0.001), because of an increase of deaths by heart failure; patients with LVEF40% with or without syncope had a low mortality (5% and 3%). After linear logistic regression, VFl/VF and LVEF were predictors of total cardiac mortality, but only LVEF40% predicted sudden death.Syncope and the level of LVEF did not increase the incidence of VFl/VF induction after MI, but modified the cardiac mortality: induced VF increased total cardiac mortality in patients with syncope and LVEF40%, but did not increase sudden death. In patients with LVEF40%, induced VFl/VF has no significance neither in asymptomatic patients nor in those with syncope.

Resume L’induction d’une tachycardie ventriculaire (TV) apres un infarctus du myocarde est consideree comme un signe de risque de TV et de mort subite chez les patients asymptomatiques. Le but de cette etude a ete de savoir si la survenue d’une syncope modifie les resultats generaux de la stimulation ventriculaire programmee (SVP) apres l’infarctus et le pronostic de ces patients. Methode. – La population de l’etude a concerne 1057 patients qui avaient une histoire d’infarctus de plus d’un mois et qui n’avaient pas de TV spontanee documentee. Huit cent trente-six d’entre eux (groupe I) etaient asymptomatiques et 228 (groupe II) avaient presente au moins une syncope. La SVP a utilise jusqu’a trois extrastimuli delivres sur trois cycles et dans deux sites du ventricule droit. Les patients ont ete suivis entre six mois et cinq ans ou jusqu’a la transplantation cardiaque. Resultats. – une TV monomorphe inferieure a 280/minute a ete induite chez 238 patients du groupe I (28 %) et 62 du groupe II (27 %). Un flutter ou une fibrillation ventriculaire a ete induite chez 245 patients du groupe I (29 %) et 42 du groupe II (18 %) ( p Les patients ont differe par leur pronostic. La mortalite cardiaque (par insuffisance cardiaque et mort subite) a ete de 13 % chez les patients du groupe I et 34 % chez ceux du groupe II qui avaient des TV inductibles ( p p Conclusion. – Le risque d’induction d’une TV monomorphe inferieure a 280/minute a ete similaire chez les patients asymptomatiques et ceux qui avaient presente une syncope apres un infarctus du myocarde. En revanche, la notion de syncope a augmente significativement la mortalite cardiaque des patients avec TV inductible et aussi celle de ceux qui avaient un flutter ou une fibrillation ventriculaire inductible.

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.To investigate the results of PVS after MI, according to date of completion.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.Group III was older (61 +/- 11 years) than groups I (56 +/- 11) and II (58 +/- 11) (P0.002). Left ventricular ejection fraction (LVEF) was lower in group III (36.5 +/- 11%) than in groups I (44 +/- 15) and II (41 +/- 12) (P0.000). Monomorphic VT270 beats/min was induced as frequently in group III (28%) as in group II (22.5%) but more frequently than in group I (20%) (P0.03). Ventricular fibrillation and flutter (VF) was induced less frequently in group III (14%) than in groups I (28%) (P0.0004) and II (30%) (P0.0000). Low left ventricular ejection fraction (LVEF) and date of inclusion (before/after 2000) were predictors of VT or VF induction on multivariate analysis.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.

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.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.RM was highly effective in the long-term prevention of inappropriate ICD shocks.

Several arrhythmias were reported in myotonic dystrophy (MD).To evaluate the prevalence of atrial fibrillation (AF) and atrial flutter (AFL) in MD and the clinical consequences.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.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%; P0.01). Univariate analysis indicated that age40 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 age40 (odds ratio: 3.14) were the sole independent variables predicting death.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.

The use of drugs is the subject of numerous recommendations. The purpose of this study was to evaluate the prevalence of drug-related sudden deaths (SD) and the possible changes during these past 20 years.271 patients, 205 men, 66 women aged from 12 to 88 years (mean 59 ± 15) were admitted after SD resuscitation outside the acute phase of myocardial infarction, 146 before 2000 (group I), 125 between 2000 and 2010 (group II). Complete check-up was performed.Ischemic HD (41%) vs (37%), idiopathic dilated cardiomyopathy (12%) vs (11%), various HD (5%) vs (8%) were as frequent in groups I and II. Valvular HDs were more frequent in group I than II (12%) vs 6% (p0.01). Abnormalities at ECG (preexcitation syndrome, conduction disturbance, atrial fibrillation or ion channel disorders) were less frequent in group I than II (8%) vs (18%) (p0.02). Drug-facilitated or related SD's did not change in groups I and II: 54 patients presented a drug-related ventricular fibrillation or asystole, 16% in group I and 24% (NS) in group II. SD was caused by hypokalemia, QT interval increase or conduction disturbance. HD or abnormal ECG was present in 42 patients. Digoxin, diuretics, calcium inhibitors, betablockers, antiarrhythmic drugs alone or in association were mainly implicated.Drug-related arrhythmias continue to explain or favour at least 20% of SDs. Despite numerous recommendations on the use of drugs, the prevalence of fatal events that may be attributed to a cardiovascular drug does not decrease between the years before 2000 and after 2000.

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 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 1 for leads, leading to a total number of 278/1051 (26.4%) device with recall alerts, divided into 196 generator failures and 82 lead failures. Premature generator replacement was performed in 11 patients whereas 9 patients underwent lead replacement. There was no major complications attributable to advisory device replacement, and minor complications occurred only in 1 patient (lead extraction failure). Recalls accounted for 593 extra out-patient 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 i. Conclusions ICD recalls and safety alerts frequently occur in ICD recipients and tend to increase in number and rate. Although potentially serious, they are not associated with substantial complications. Financial implications are important.

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.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.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 €.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.

Multiple factors, in addition to left ventricular ejection fraction (LVEF) influence the risk of mortality in coronary artery disease. The purpose of this study was to evaluate the main causes of syncope after myocardial infarction (MI) and to propose an algorithm of management.356 patients consecutively admitted for syncope and history of MI (1 month), without ventricular tachycardia (VT), underwent echocardiography, Holter monitoring, head-up tilt test, exercise testing, signal-averaged ECG, electrophysiological study (EPS) and evaluation of coronary status. The mean follow-up was 4±2 years.Monomorphic VT, ventricular flutter or fibrillation (VF) and supraventricular tachyarrhythmia were respectively induced at EPS in 87, 63 and 39 patients; conduction disturbances were noted in 23 patients, and 57 patients had several abnormalities. Among the 144 patients with negative EPS, coronary ischaemia was identified in 37 patients, and hypervagotonia in 27 patients. All studies remain negative in 84 patients (23.6%), more frequently women (p0.001). Four patients died suddenly during follow-up. A longer QRS duration, a lower LVEF and grade IVa,b of Lown on Holter ECG were associated with the induction of VT. LVEF40% and VT/VF induction were predictors of cardiac mortality, VT was a predictor of sudden death, and low LVEF and advanced age were predictors of death by heart failure.Myocardial ischaemia, hypervagotonia, conduction abnormalities, ventricular or supraventricular tachyarrhythmias were identified in 76% of patients with syncope after MI. Several factors of syncope were found in 57 patients (16%). Non-invasive rhythmological and systematic coronary status assessment should be recommended in patients with syncope following MI.