Incidence and outcomes of infective endocarditis after transcatheter aortic valve implantation versus surgical aortic valve replacement.

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) is an alternative to surgical aortic valve replacement (AVR) in aortic stenosis (AS). Infective endocarditis (IE) in patients with prosthetic heart valves is associated with significant morbidity and mortality. Data on the incidence, risk factors, and outcomes of IE after TAVI are conflicting. We evaluated these issues in patients with percutaneous TAVI vs. isolated surgical AVR (SAVR) at a nationwide level. METHODS: Based on the administrative hospital discharge database, the study collected information for all patients with aortic stenosis treated with AVR in France between 2010 and 2018. RESULTS: A total of 47 553 patients undergoing TAVI and 60 253 patients undergoing isolated SAVR were identified. During a mean follow-up of 2.0 years (median (25th to 75th percentile) 1.2 (0.1-3.4) years), the incidence rates of IE were 1.89 (95% confidence interval (CI) 1.78-2.00) and 1.40 (95% CI 1.34-1.46) events per 100 person-years in unmatched TAVI and SAVR patients, respectively. In 32 582 propensity-matched patients (16 291 with TAVI and 16 291 with SAVR), risk of IE was not different in patients treated with TAVI vs. SAVR (incidence rates of IE 1.86 (95% CI 1.70-2.04) %/year vs 1.71 (95% CI 1.58-1.85) %/year respectively, relative risk (RR) 1.09, 95% CI 0.96-1.23). In these matched patients, total mortality was higher in TAVI patients with IE (43.0% 95% CI 37.3-49.3) than in SAVR patients with IE (32.8% 95% CI 28.6-37.3; RR 1.32, 95% CI 1.08-1.60). DISCUSSION: In a nationwide cohort of patients with AS, treatment with TAVI was associated with a risk of IE similar to that following SAVR. Mortality was higher for patients with IE following TAVI than for those with IE following SAVR.

Joint Position Paper of the Working Group of Pacing and Electrophysiology of the French Society of Cardiology (SFC) and the Société française d'imagerie cardiaque et vasculaire diagnostique et interventionnelle (SFICV) on magnetic resonance imaging in patients with cardiac electronic implantable devices.

Magnetic resonance imaging (MRI) has become the reference imaging for the management of a large number of diseases. The number of MR examinations increases every year, simultaneously with the number of patients receiving a cardiac electronic implantable device (CEID). A CEID was considered an absolute contraindication for MRI for years. The progressive replacement of conventional pacemakers and defibrillators by MR-conditional CEIDs and recent data on the safety of MRI in patients with "MR-nonconditional" CEIDs have progressively increased the demand for MRI in patients with a CEID. However, some risks are associated with MRI in CEID carriers, even with "MR-conditional" devices because these devices are not "MR-safe". A specific programing of the device in "MR-mode" and monitoring patients during MRI remain mandatory for all patients with a CEID. A standardized patient workflow based on an institutional protocol should be established in each institution performing such examinations. This joint position paper of the Working Group of Pacing and Electrophysiology of the French Society of Cardiology and the Société française d'imagerie cardiaque et vasculaire diagnostique et interventionnelle (SFICV) describes the effect and risks associated with MRI in CEID carriers. We propose recommendations for patient workflow and monitoring and CEID programming in MR-conditional, "MR-conditional nonguaranteed" and MR-nonconditional devices.

Implantable loop recorder for recurrent syncopes.

Syncope is a common disorder which may recur and impair the survival and the quality of life of the patients. The objective of the investigation of syncope is to diagnose the cardiac etiology, as mortality rate is high. Implantable loop recorder or insertable cardiac monitor (ICM) is a useful tool to establish a correlation between syncope and heart rhythm. About half of implanted patients complain of a new syncope and about 50% of these patients had cardiac rhythm disturbances on ICM. The most frequent is a sinus bradycardia or sinus arrest, but these results depend on the age of patients, resting electrocardiography (ECG) abnormalities and structural cardiac disease. A classification of the mechanisms of recurrent syncopes has been defined with the results of the ISSUE study, separating the syncope due to primary cardiac arrhythmia from neurally-mediated syncope and from unknown syncope. The analysis of the presyncopal phase on the ICM restored ECG allows physicians to adapt the treatment (antiarrhytmic agents or pacemaker) and optimize the programming of the pacemaker when necessary. It is early recommended to implant the ICM in patients affected with syncope with normal physical examination, normal ECG and without structural heart disease and negative tilt testing. In the presence of cardiac disease, it is recommended to implant ICM after performing an electrophysiological study and tilt testing. In syncope patients with depressed left ventricular ejection fraction, the implantation of an automatic implantable cardiac defibrillator is preferable. The indications of the ICM tend to be extended to new syncope populations such as pediatric patients and epileptic population. Early application of ICM reduces the cost of the investigation of the patients suffering from syncope, especially when the electrophysiological study is avoided. In the future the implantation of the ICM should be early discussed in the Syncope Unit to shorten the duration and the cost of the hospitalizations of the patients with recurrent syncopes.

Incidence, characteristics, and mortality of infective endocarditis in France in 2011.

OBJECTIVES: We assessed the determinants of mortality in infective endocarditis (IE), using the national hospital discharge databases (HDD) in 2011. METHODS: IE stays were extracted from the national HDD, with a definition based on IE-related diagnosis codes. This definition has been assessed according to Duke criteria by checking a sample of medical charts of IE giving a predictive positive value of 86.1% (95% confidence interval (CI): 82.7% - 89.5%). The impact of heart valve surgery on survival has been studied if performed during the initial stay, and over the year of follow-up. Risk factors of in-hospital mortality were identified using logistic regression model for the initial stay and Cox Time-dependent model for the 1-year mortality. RESULTS: The analysis included 6,235 patients. The annual incidence of definite IEs was 63 cases/million residents. Staphylococci and Streptococci were the most common bacteria (44% and 45%, respectively). A valvular surgery was performed in 20% of cases, but substantial variations existed between hospitals. The in-hospital mortality was 21% (ranging 12% to 27% according to the region of patients), associated with age>70, chronic liver disease, renal failure, S. aureus, P. aeruginosa or candida infection and strokes whereas valvular surgery, a native valve IE or intraveinous drug use (right heart IE) were significantly protective for an initial death. The same factors were associated with the one-year mortality, except for valvular surgery which was associated with a 1.4-fold higher risk of death during the year post IE. CONCLUSION: We reported a high IE incidence rate. Valvular surgery was considerably less frequent in this study than in the previous published data (near 50%) whereas mortality was similar. Surgery was associated with higher survival if undergone within the initial stay. There were significant regional differences in frequency of surgery but it did not impact mortality.

[Screening and clinical implications of silent atrial fibrillation]. / Dépistage et implications cliniques de la fibrillation atriale silencieuse.

Each year, 5 million new cases of atrial fibrillation (AF) are diagnosed, and the data for the last 20 years show that its incidence has continued to grow. The aging of the population is considered a major explanation for this pandemic phenomenon. The complications associated with atrial arrhythmia are numerous and frequent, with in the first place thromboembolic events. In addition to symptomatic atrial fibrillation, AF may be diagnosed by chance during a systematic ECG, an external Holter or a continuous ECG monitor, or in the memories of implanted cardiac devices. This is called silent AF. Despite numerous studies, silent AF is still largely under-diagnosed and unrecognized in everyday clinical practice, although it is a frequent condition with potentially serious consequences (especially thromboembolic events). Thanks to the development of new diagnostic tools, which are scientifically validated and readily available, the detection of AF has improved significantly, leading to better therapeutic management, in particular anticoagulant therapy. From this perspective, mass screening for silent AF using these new technologies is a major step forward in e-health development. The cost of screening and the heterogeneity of populations affected by silent AF, however, remain major obstacles.

[Evaluation of the cost of complications of automatic implantable defibrillators]. / Evaluation du coût des complications des défibrillateurs cardiaques automatiques implantables.

The automatic implantable defibrillator (AID) has been shown to prevent sudden death but it frequently gives rise to complications. These complications seem to be costly but they do not figure in the economic assessments of AID. From 1989 to 2003, 202 patients (173 men, age 58 +/- 14 years) received consecutively 264 AID in the same centre of implantation. The authors studied the complications of these implantations. The medical indication was secondary (documented spontaneous ventricular tachycardia or fibrillation) in 145 patients (71.8%) and prophylactic in the remaining 57 patients (28.2%). During the 36 month (+/- 35) follow-up, 40.6% patients had an appropriate treatment: 50.3% in the secondary prevention group versus 15.8% in the prophylactic implantation group. The one year, 5 and 15 year survival rates were 99, 88 and 85% respectively. Eighty seven complications were observed resulting in a long term complication in 36.7% of patients. These complications were: inappropriate electric shock, n=24 (27.6%), fractured catheters, n=12 (13.6%), haematomas, n=12 (13.6%), loss of function of the AID, n=10 (11.4%), infection, n=6 (6.8%), pneumothorax, n=7 (8.0%), and others n=16 (18.4%). The cost of these complications was assessed in terms of hospital stay in intensive care (1010.40 euros per day) or in the general cardiology wards (546.70 euros per day). The complications resulted in 502 days of additional hospital stay (5.77 days per complication) with a total cost of 285 655.20 euros (3283.40 euros per complication). The most expensive complications in terms of hospital stay were: infections (24.5 days), fractured catheter (5.75 days), and postoperative haematoma (5.5 days). These results indicate a significant cost of complications which should be indicated in the economic evaluation of AID.

[Effects of delay in onset of revascularisation strategies in the acute phase of myocardial infarction]. / Place du délai de prise en charge dans la stratégie de revascularisation à la phase aiguë de l'infarctus du myocarde. Données issues de la vie réelle.

BACKGROUND: thrombolysis (THL) and primary percutaneous coronary intervention (PCI) are therapeutic options in acute myocardial infarction (MI). These strategies have similar efficiency, particularly in the early phase. However, in these randomized studies, different times to treatment (TT) threshold are recognized as discriminant. OBJECTIVES: to validate, on a one year mortality criteria the best TT threshold in the real life. METHODS: 794 patients, admitted directly in our institution with a Ml< or =12 hours; 299 were treated by THL and 495 by PCI. The primary end-point was 1-year mortality according to TT and strategy of revascularization. Three TT thresholds were tested (120, 150 and 180 min) to define the best strategy of revascularisation. RESULTS: only the 150 min TT threshold showed a significant difference between the two strategies. If TT was less than 150 min, relative risk of 1-year mortality was 1.36 (p=0.62) for patients treated by THL compared to those treated with PCI. By contrast, the relative risk of one year mortality was 1.95 if Tr was greater than 150 min (p=0.02). CONCLUSION: TT is a key factor to define the best strategy of reperfusion. The critical threshold seems to be at 150 min. THL should be considered as a therapeutic choice only if administered within the first 150 min. After this delay, primary PCI should be preferred.

Heart rate variability in rats with chronic hypoxic pulmonary hypertension.

The precise role of pulmonary hypertension as a possible factor inducing a decrease in heart rate variability is poorly known. Spectral analysis of heart rate variability (HRV) was carried out in 21 Wistar rats before and after exposure to normoxia (N = 10) or to 3 weeks of hypobaric hypoxia inducing chronic pulmonary hypertension and right ventricular hypertrophy (N= 11). Continuous ECG was recorded in conscious animal at rest. Compared to the control group, rats exposed to hypoxia had a similar heart rate but a lower overall HRV (total power, 27.9 +/- 15.2 vs. 57.6 +/- 24.7 ms2, P < 0.01). Low frequency power (0.25-0.8 Hz) and high frequency power (0.8-3 Hz) were similar in both groups suggesting that HRV was decreased in the very low frequency power (0-0.25 Hz). The effects of atropine and propranolol on heart rate and HRV were similar in rats exposed or not to hypoxia. HRV is decreased in rats with hypoxic induced pulmonary hypertension, mainly in the very low frequency band, suggesting an increase in sympathetic activity. However, this decrease is moderate and the modulation of HRV with pharmacologic autonomic blockade remains similar to that of normal rats.

[Risk stratification in atrial and ventricular arrhythmias]. / Stratification du risque dans les troubles du rythme auriculaire et ventriculaire.

Atrial fibrillation, the most frequent arrhythmia, has a growing incidence with increasing age and the most important complication of the disease is thromboembolic events that may be prevented by antivitamin K. They are the most efficient therapeutic class for the prevention of these events but they are associated with an increased haemorrhagic risk leading to a reduced prescription in general practice. Optimisation of the management should be based on an individual evaluation of the thromboembolic and haemorrhagic risks, taking into account age, the presence of an associated heart disease, hypertension, diabetes, history of cerebrovascular event, history of previous haemorrhagic event and the ability to achieve a stable target INR. The challenge in ventricular arrhythmias lies in identifying a high risk of sudden death, mainly related to ventricular fibrillation. In patients with structural heart disease, left ventricular dysfunction is the strongest predictor of sudden death. Non invasive markers such as non sustained ventricular tachycardia, late ventricular potentials, decreased heart rate variability and baroreflex sensitivity, and repolarization altemans are further elements to assess risk. However, most of these markers have a poor positive predictive value and a low specificity. In patients with normal hearts, genetic predisposition may in the future identify high risk patients. The electrophysiologic study with programmed ventricular stimulation remains a costly and invasive method and only has a strong positive predictive value in ischemic cardiomyopathy. More precise algorithms for risk stratification are thus needed that may help the strategy of therapy with prophylactic implantable cardioverter defibrillator in the future.

Heart rate variability in idiopathic dilated cardiomyopathy: characteristics and prognostic value.

OBJECTIVES: This study was designed to evaluate heart rate variability (HRV) in patients with idiopathic dilated cardiomyopathy (IDC), to determine its correlation with hemodynamic variables and ventricular arrhythmias and to evaluate its prognostic value in IDC. BACKGROUND: Previous studies have shown that HRV could predict arrhythmic events in patients after infarction, but the characteristics of HRV in IDC have not been fully established. METHODS: Time domain analysis of HRV on 24-h electrocardiographic (ECG) recording was performed in 93 patients with IDC, and results were compared with those in 63 control subjects. RESULTS: Patients with IDC, even those without congestive heart failure, had significantly lower values for HRV than those of control subjects. HRV was related to left ventricular shortening fraction (R = 0.5, p = 0.0001) and to peak oxygen uptake (R = 0.53, p = 0.01). HRV was not different in patients with runs of ventricular tachycardia or in patients with late potentials on the signal-averaged ECG. During a mean follow-up period (+/-SD) of 49.5 +/- 35.6 months, patients with reduced HRV had an increased risk of cardiac death or heart transplantation (p = 0.006). On multivariate analysis, cardiac events were predicted by increased left ventricular end-diastolic diameter (p = 0.0001), reduced standard deviation of all normal to normal RR intervals (p = 0.02) and increased pulmonary capillary wedge pressure (p = 0.04). CONCLUSIONS: Decreased HRV in patients with IDC is related to left ventricular dysfunction and not to ventricular arrhythmias. Analysis of HRV can identify patients with IDC who have an increased risk of cardiac death or heart transplantation.

Prognostic value of heart rate variability for sudden death and major arrhythmic events in patients with idiopathic dilated cardiomyopathy.

OBJECTIVE: This study was designed to evaluate the prognostic value of heart rate variability for sudden death, resuscitated ventricular fibrillation or sustained ventricular tachycardia in patients with idiopathic dilated cardiomyopathy. BACKGROUND: Previous studies have shown that heart rate variability could predict arrhythmic events and sudden death in postinfarction patients, but the prognostic value of heart rate variability for arrhythmic events or sudden death in patients with idiopathic dilated cardiomyopathy has not been established. METHODS: Time and frequency domain analysis of heart rate variability on 24-h electrocardiographic (ECG) recording was assessed in 116 patients with idiopathic dilated cardiomyopathy (91 men, aged 51+/-12 years, left ventricular ejection fraction 34+/-12%). RESULTS: Mean follow-up (+/-SD) was 53+/-39 months. Sixteen patients reached one of the defined study end-points (sudden death, resuscitated ventricular fibrillation or sustained ventricular tachycardia) during follow-up. Using multivariate analysis, only reduced standard deviation of all normal-to-normal intervals (SDNN) (p = 0.02) and ventricular tachycardia during 24-h ECG recording (p = 0.02) predicted sudden death and/or arrhythmic events. For SDNN, a cutoff level of 100 ms seemed the best for the risk stratification. CONCLUSIONS: Decrease in heart rate variability is an independent predictor of arrhythmic events and sudden death in idiopathic dilated cardiomyopathy, whether the mechanism of sudden death is ventricular tachyarrhythmia or not.

[Evaluation after 20 years of a case of Takayasu's disease that presented with aortic regurgitation]. / Evolution après 20 ans d'une maladie de Takayasu Révélée par une insuffisance aortique.

Takayasu's disease is a segmental multifocal affection of medium and large arteries. The diagnosis is based on the association of stenotic and aneurismal lesions of the aorta and its branches secondary to an inflammatory infiltration of the media and adventitia. Cases of aortic regurgitation associated with aneurismal dilatation of the ascending aorta as the presenting features of Takayasu's disease, as in this case, are rare. Histological examination of the aortic wall may help establish the diagnosis by showing signs of aortitis. The other usual arterial lesions are sometimes missing at the initial phase of the disease. A late histological diagnosis may be difficult as the inflammatory lesions tend to be progressively replaced by fibrotic lesions or a banal atheroma.

[Indications for automatic implantable defibrillators in patients with the Brugada syndrome]. / Indications du défibrillateur cardiaque automatique implantable dans le syndrome de Brugada.

Brugada syndrome is a primary electrical cardiac disease characterized by an ST segment elevation in V1-V2 leads on surface ECG and an increased risk of polymorphic ventricular tachyarrhythmia (ventricular tachycardia and/or ventricular fibrillation). The objective of the treatment is to prevent sudden death and it therefore includes in some cases the implantation of an automatic implantable cardiac defibrillator (AICD). In secondary prevention (i.e. after a first episode of resuscitated ventricular fibrillation), the implantation of AICD is mandatory (indication of class 1 level A). In primary prevention (i.e. in patients without documented ventricular fibrillation), the guidelines are not definitively established. We may consider two different clinical situations. First, the patient complains from syncope and this justifies the implantation of an AICD. Second, the patient is asymptomatic and the physician has to discuss the implantation of an AICD. Two parameters should be analysed: the pattern of ECG and the result of right programmed ventricular stimulation. An evident ST segment elevation (>2 mm) is associated with a high risk of sudden death. Likewise, the inducibility of a ventricular tachycardia or fibrillation is considered at the present time as a factor linked to sudden death and justifies the implantation of an AICD. On the other hand, a normal resting ECG only associated with a provoked ST segment elevation by class I antiarrhythmic drug (flecainide) defines a group of patients with a low risk of sudden death, and these patients do not require the implantation of an AICD.

[Postmarketing surveillance in patients with cardiac pace-makers or automatic implantable defibrillators]. / Aspects généraux et réglementaires de la matériovigilance des stimulateurs et des défibrillateurs cardiaques.

This article includes an overview of the actual French control and regulation system of the safety alerts involving pacemakers and implantable cardioverter-defibrillator and an evaluation of the general information and trends about the characteristics of the reported incidents obtained in the last years in that field. The national security agencies have the mission to collect the data on safety and efficacy of medical devices but manufacturers, physicians and patients also have a role to play. The technical appreciation of the necessity of a notification is not easy in some cases but the lack of notification of a severe incident may lead to heavy penal consequences. If doubtful cases, one should keep in mind the spirit of these safety systems: a collective insurance against the risks related to the use of medical devices. In the 10 last years, the annual advisory rate was increased. The pacemakers were recalled more frequently than implantable cardioverter-defibrillators in absolute value but less frequently in relative value (advisories per 100 person-years). This increase may be related to the growing number of device implants and expanding indications for device therapy, to the increasing sophistication of the devices and to the modifications in the regulation aspects of these problems with a closer attention of users and physicians to the several types of malfunctions.

Effect of verapamil on heart rate variability in subjects with normal hearts.

Heart rate variability on 24-hour electrocardiographic recording was assessed in 23 patients without structural heart disease before and after 2 months of oral treatment with verapamil prescribed for paroxysmal atrioventricular nodal reentrant tachycardia. Verapamil had no significant effect on overall heart rate variability in the frequency domain, but it increased ultra low frequency power and decreased the low-frequency/high-frequency ratio, deemed to be a marker of sympathetic activity.

Long-term prognostic value of time domain analysis of signal-averaged electrocardiography in idiopathic dilated cardiomyopathy.

The aim of this study was to evaluate the long-term prognostic value of signal-averaged electrocardiography (SAECG) in idiopathic dilated cardiomyopathy (IDC). Time domain analysis of SAECG was assessed in 131 patients with angiographically confirmed IDC (age 52+/-12 years; 108 men; left ventricular ejection fraction 33+/-12%) using specific criteria in 44 patients with bundle branch block. Late potentials (LP) on SAECG were present in 27% of the patients. Patients with LP had a similar left ventricular ejection fraction and a similar left ventricular end-diastolic diameter than patients with a normal SAECG. With a follow-up of 54+/-41 months, 24 patients suffered cardiac death and 19 had major arrhythmic events (sudden death, resuscitated ventricular fibrillation, or sustained ventricular tachycardia). Patients with LP had an increased risk of all-cause cardiac death (RR 3.3, 95% confidence interval 1.5 to 7.5, p = 0.004) and of arrhythmic events (RR 7.2, 95% confidence interval 2.6 to 19.4, p = 0.0001). Using multivariate analysis, only LP on SAECG (p = 0.001), reduced SD of all normal-to-normal intervals (SDNN) (p = 0.002), increased pulmonary capillary wedge pressure (p = 0.005), and history of sustained ventricular tachyarrhythmia (p = 0.02) predicted cardiac death. A history of previous sustained ventricular tachyarrhythmia (p = 0.0001), reduced SDNN (p = 0.003), and LP on SAECG (p = 0.006) were the only independent predictors of major arrhythmic events. Results were not altered when considering separately patients with or without bundle branch block, or after exclusion of patients with a history of sustained ventricular tachyarrhythmia. This study is one of the first to suggest that LP on SAECG is an independent predictor of all-cause cardiac death and is of high interest for arrhythmia risk stratification in IDC.