Peri-procedural routines, implantation techniques, and procedure-related complications in patients undergoing implantation of subcutaneous or transvenous automatic cardioverter-defibrillators: results of the European Snapshot Survey on S-ICD Implantation (ESSS-SICDI).

The aim of this European Heart Rhythm Association (EHRA) prospective snapshot survey is to assess peri-procedural practices, implantation techniques, and short-term procedure-related complications associated with implantation of subcutaneous implantable cardioverter-defibrillator (S-ICD) or transvenous implantable cardioverter-defibrillator (TV-ICD), across tertiary European electrophysiology centres. An internet-based electronic questionnaire concerning implantation settings, peri-procedural routines, techniques, personnel, complications, and patient outcomes was sent to the centres routinely implanting both TV-ICDs and S-ICDs. The centres were requested to prospectively include consecutive patients implanted with either TV-ICD or S-ICD during the 8-week enrolment period. Overall, 20 centres from 6 countries enrolled 429 consecutive patients. Subcutaneous implantable cardioverter-defibrillators (20%) compared with TV-ICD were implanted mainly under general anaesthesia (72% vs. 14%), in the surgical operation room settings (69% vs. 43%), with more frequent prophylactic antibiotic administration (82% vs. 91%), and post-implant defibrillation testing (85% vs. 7%, all P < 0.05). Feasibility (implantation duration of 45 min) and short-term complication rates (4%) were comparable for S-ICDs and TV-ICDs, but the spectrum of complications varied, despite different baseline characteristics of patients undergoing the S-ICD vs. TV-ICD implantation. This EHRA snapshot survey provides important insights into the implantable cardioverter-defibrillator implantation routines and patient outcomes. Our study showed differences between the S-ICD and TV-ICD implantation routines with respect to implantation settings, peri-procedural management, and pre-defined procedural endpoints. However, the comparable duration of S-ICD or TV-ICD implantation and similar rates of peri-procedural complications indicate that both devices can be routinely used in clinical practice.

Early and Late Atrial Arrhythmias After Lung Transplantation　- Incidence, Predictive Factors and Impact on Mortality.

BACKGROUND: Atrial arrhythmias (AAs) are frequent after lung transplantation (LT) and late postoperatively. Several predictive factors of early postoperative AAs after LT have been identified but those of late AAs remain unknown. Whether AA after LT affects mortality is still being debated. This study assessed in a large cohort of LT patients the incidence of AAs early and late after surgery, their predictive factors and their effect on mortality.Methods and Results:We studied 271 consecutive LT patients over 9 years. Mean follow-up was 2.9±2.4 years. 33% patients developed postoperative AAs. Age (odds ratio (OR) 2.35; confidence interval (CI) [1.31-4.24]; P=0.004) and chronic obstructive pulmonary disease (OR 2.13; CI [1.12-4.03]; P=0.02) were independent predictive factors of early AAs. Late AAs occurred 2.2±2.7 years after transplant in 8.8% of the patients. Pretransplant systolic pulmonary arterial pressure (PTsPAP) was the only independent predictive factor of late AA (OR 1.028; CI [1.001-1.056]; P=0.04). Double LT was associated with long-term freedom from atrial fibrillation (AF) but not from atrial flutter (AFL). Early and late AAs after surgery had no effect on mortality. Double LT was associated with better survival. CONCLUSIONS: Early AA following LT is common in contrast with the low occurrence of late, often organized, AA. Early and late AAs do not affect mortality. PTsPAP is an independent predictor of late AA. Double LT protects against late AF but not AFL.

Causes-of-death analysis of patients with cardiac resynchronization therapy: an analysis of the CeRtiTuDe cohort study.

AIMS: The choice of resynchronization therapy between with (CRT-D) and without (CRT-P) a defibrillator remains a contentious issue. Cause-of-death analysis among CRT-P, compared with CRT-D, patients could help evaluate the extent to which CRT-P patients would have additionally benefited from a defibrillator in a daily clinical practice. METHODS AND RESULTS: A total of 1705 consecutive patients implanted with a CRT (CRT-P: 535 and CRT-D: 1170) between 2008 and 2010 were enrolled in CeRtiTuDe, a multicentric prospective follow-up cohort study, with specific adjudication for causes of death at 2 years. Patients with CRT-P compared with CRT-D were older (P < 0.0001), less often male (P < 0.0001), more symptomatic (P = 0.0005), with less coronary artery disease (P = 0.003), wider QRS (P = 0.002), more atrial fibrillation (P < 0.0001), and more co-morbidities (P = 0.04). At 2-year follow-up, the annual overall mortality rate was 83.80 [95% confidence interval (CI) 73.41-94.19] per 1000 person-years. The crude mortality rate among CRT-P patients was double compared with CRT-D (relative risk 2.01, 95% CI 1.56-2.58). In a Cox proportional hazards regression analysis, CRT-P remained associated with increased mortality (hazard ratio 1.54, 95% CI 1.07-2.21, P = 0.0209), although other potential confounders may persist. By cause-of-death analysis, 95% of the excess mortality among CRT-P subjects was related to an increase in non-sudden death. CONCLUSION: When compared with CRT-D patients, excess mortality in CRT-P recipients was mainly due to non-sudden death. Our findings suggest that CRT-P patients, as currently selected in routine clinical practice, would not potentially benefit with the addition of a defibrillator.

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).

Sudden cardiac arrest associated with early repolarization.

BACKGROUND: Early repolarization is a common electrocardiographic finding that is generally considered to be benign. Its potential to cause cardiac arrhythmias has been hypothesized from experimental studies, but it is not known whether there is a clinical association with sudden cardiac arrest. METHODS: We reviewed data from 206 case subjects at 22 centers who were resuscitated after cardiac arrest due to idiopathic ventricular fibrillation and assessed the prevalence of electrocardiographic early repolarization. The latter was defined as an elevation of the QRS-ST junction of at least 0.1 mV from baseline in the inferior or lateral lead, manifested as QRS slurring or notching. The control group comprised 412 subjects without heart disease who were matched for age, sex, race, and level of physical activity. Follow-up data that included the results of monitoring with an implantable defibrillator were obtained for all case subjects. RESULTS: Early repolarization was more frequent in case subjects with idiopathic ventricular fibrillation than in control subjects (31% vs. 5%, P<0.001). Among case subjects, those with early repolarization were more likely to be male and to have a history of syncope or sudden cardiac arrest during sleep than those without early repolarization. In eight subjects, the origin of ectopy that initiated ventricular arrhythmias was mapped to sites concordant with the localization of repolarization abnormalities. During a mean (+/-SD) follow-up of 61+/-50 months, defibrillator monitoring showed a higher incidence of recurrent ventricular fibrillation in case subjects with a repolarization abnormality than in those without such an abnormality (hazard ratio, 2.1; 95% confidence interval, 1.2 to 3.5; P=0.008). CONCLUSIONS: Among patients with a history of idiopathic ventricular fibrillation, there is an increased prevalence of early repolarization.

Implantable cardioverter-defibrillators in France: practices and regional variability.

AIMS: The rates of cardiac defibrillator implantation (ICD) in Europe and within countries are heterogeneous. We examined the characteristics of ICD recipients and device implantation rates in France, with the goal of identifying patterns and regional differences in medical practices. METHODS AND RESULTS: We compiled the information available on devices and patients from a manufacturer's database for the years 2008 and 2009 and the Stidefix national registry from January 2008 to April 2010 and reported the descriptive statistics and comparisons of implantation practices among regions. We analysed data from 10 766 patients enrolled in Stidefix (mean age=63 ± 13 years; 83% men) after implantation of single-chamber (24%), dual-chamber (33%), or triple-chamber (43%) ICD. Implantation was for primary prevention in 63% of patients. Between 2008 and 2009, the national implant rate increased from 126 to 147 per million inhabitants, with regional variations related to the number of cardiologists and of implant centres. Patients were significantly older and more likely to undergo implantation for primary prevention or for cardiac resynchronization therapy (CRT) in higher-volume regions. In Ile de France (Paris and its suburbs), patients tended to be younger, as in low-implantation regions, but with a high rate of CRT implants, as in high-implantation regions. A comparison of the Stidefix data with the manufacturer's database revealed that only 57% of all ICD implanted in 2009 were reported to Stidefix. CONCLUSION: Despite an increasing rate of ICD implantation in France, important regional disparities persist, with a median position occupied by Ile de France.

Predictors for short-term progressive heart failure death in New York Heart Association II patients implanted with a cardioverter defibrillator--the EVADEF study.

BACKGROUND: Sudden cardiac death (SCD) is the predominant cause of mortality in patients with mild heart failure (HF). This 2-year follow-up, multicenter, cohort study aimed to assess the extent to which implantable cardioverter defibrillators (ICDs), by reducing SCD, lead to predominant progressive HF death in mildly symptomatic HF patients at baseline in daily medical practice. METHODS: Between June 2001 and June 2003, 1,030 New York Heart Association II patients received an ICD in 22 French centers. Sudden cardiac death and progressive HF mortality rates were assessed using competing risk methodology, and predictors for progressive HF at baseline were tested in a multivariate regression model. RESULTS: During a mean follow-up of 22 +/- 6 months, 114 deaths occurred: 12 (10.5%) due to SCD and 52 (45.6%) due to progressive HF (24-month cause-specific mortality rates of 1.2% [95% CI 0.6-1.9] and 5.4% [95% CI 4.0-6.8], respectively). Diuretics use (hazard ratio [HR] 2.8, 95% CI 1.5-5.5, P = .002), history of atrial fibrillation (HR 2.09, 95% CI 1.2-3.65, P = .01), and low ejection fraction (HR 2.7, 95% CI 1.4-4.8, P = .0008) were independent predictors for progressive HF death, whereas beta-blocker therapy was a protector (HR 0.6, 95% CI 0.3-0.9, P = .04). Half of the patients (48%) who died from progressive HF within 2 years of ICD implant initially presented with enlarged QRS (> or =120 milliseconds). CONCLUSIONS: Because of ICD efficiency, progressive HF is the main cause of death within 2 years of implant, although these patients are only mildly symptomatic at implantation. In addition to optimal pharmacologic therapy, these results raise the question of systematically implanting ICDs with cardiac resynchronization therapy in patients with electrical asynchronism at baseline.

In-hospital complications after invasive strategy for the management of Non STEMI: women fare as well as men.

BACKGROUND: To analyze the in-hospital complication rate in women suffering from non-ST elevation myocardial infarction treated with percutaneous coronary intervention (PCI) compared to men. METHODS: The files of 479 consecutive patients (133 women and 346 men) suffering from a Non STEMI (Non ST-segment elevation myocardial infarction) between the January 1st 2006 and March 21st 2009 were retrospectively analyzed with special attention to every single complication occurring during hospital stay. Data were analyzed using nonparametric tests and are reported as median unless otherwise specified. A p value < .05 was considered significant. RESULTS: As compared to men, women were significantly older (75.8 vs. 65.2 years; p < .005). All cardiovascular risk factors but tobacco and hypertension were similar between the groups: men were noticeably more often smoker (p < .0001) and women more hypertensive (p < .005). No difference was noticed for pre-hospital cardiovascular drug treatment. However women were slightly more severe at entry (more Killip class IV; p = .0023; higher GRACE score for in-hospital death - p = .008 and CRUSADE score for bleeding - p < .0001). All the patients underwent PCI of the infarct-related artery after 24 or 48 hrs post admission without sex-related difference either for timing of PCI or primary success rate. During hospitalization, 130 complications were recorded. Though the event rate was slightly higher in women (30% vs. 26% - p = NS), no single event was significantly gender related. The logistic regression identified age and CRP concentration as the only predictive variables in the whole group. After splitting for genders, these parameters were still predictive of events in men. In women however, CRP was the only one with a borderline p value. CONCLUSIONS: Our study does not support any gender difference for in-hospital adverse events in patients treated invasively for an acute coronary syndrome without ST-segment elevation and elevated troponin.

Subcutaneous implantable cardioverter defibrillator indication in prevention of sudden cardiac death in difficult clinical situations: A French expert position paper.

The introduction of a new technology always raises questions about its place compared with the reference technology. The use of an implantable cardioverter defibrillator to prevent sudden cardiac death is now a widely proven technique, with a clear statement of its indication in the guidelines. More recently, a subcutaneous implantable cardioverter defibrillator has been introduced, and appears to be an attractive technique as it removes the need to implant a lead inside the right ventricle to treat the patient, which should dramatically decrease the risk of complications over time. Currently, only one model of subcutaneous implantable cardioverter defibrillator is available on the market; its indications are the same as for transvenous implantable cardioverter defibrillators, except for patients who need stimulation because of conduction disorders or ventricular tachycardias that can potentially be treated effectively by antitachycardia pacing. The different technical characteristics of transvenous versus subcutaneous implantable cardioverter defibrillators therefore raise the question of which to choose in different clinical settings. The experts who participated in the preparation of this manuscript had three meetings, organized by the company Boston Scientific. Each expert prepared the draft of a section corresponding to a clinical situation. The choice between transvenous versus subcutaneous implantable cardioverter defibrillator was then voted on by all the experts. The results of the votes are presented in this manuscript, as it seemed important to us to show the disparities of opinion that can exist in certain situations. The votes were cast independently and anonymously.

Joint Position Paper of the Working Group of Pacing and Electrophysiology of the French Society of Cardiology and the French Society of Diagnostic and Interventional Cardiac and Vascular Imaging on magnetic resonance imaging in patients with cardiac electronic implantable devices.

Magnetic resonance imaging (MRI) has become the reference imaging technique for the management of a large number of diseases. The number of MRI examinations increases every year, simultaneously with the number of patients receiving a cardiac electronic implantable device (CEID). The presence of a CEID was considered an absolute contraindication for MRI for many years. The progressive replacement of conventional pacemakers and defibrillators by "magnetic resonance (MR)-conditional" CEIDs and recent data on the safety of MRI in patients with "MR-non-conditional" CEIDs have gradually 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". Specific programming 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 French Society of Diagnostic and Interventional Cardiac and Vascular Imaging describes the effect of and risks associated with MRI in CEID carriers. We propose recommendations for patient workflow and monitoring and CEID programming in MR-conditional, "MR-conditional non-guaranteed" and MR-non-conditional devices.

Lower circulating Sta-Liatest D-Di levels in patients with aortic intramural hematoma compared with classical aortic dissection.

OBJECTIVE: To compare the diagnostic value of circulating Sta-Liatest D-Di levels in classic acute aortic dissection (AAD) and in aortic intramural hematoma (AIH), a variant of AAD without a patent false lumen. DESIGN: Single-center retrospective case-control study. SETTING: University Hospital of Strasbourg, France. PATIENTS: Ninety-four consecutive patients with both confirmed AAD and d-dimer measurements at entry were included. d-dimer levels were assayed by the immunoturbidimetric method Sta-Liatest D-Di (Diagnostica Stago, Asnieres sur Seine, France). INTERVENTION: Patient characteristics and clinical evolution were analyzed. MEASUREMENTS AND MAIN RESULTS: Eighty-four patients (89%) presented a classic AAD with patent false lumen and ten (11%) presented an AIH. Clinical presentation did not differ between the two groups. The mortality rate was 0% in AIH and 26% in classic AAD. d-dimer levels were significantly lower in patients with AIH (median, 1230 ng/mL; interquartile range, 685-2645 ng/mL) than in patients with AAD with patent false lumen (median value, 9290 ng/mL; interquartile range, 3890-20,000 ng/mL; p = 0.008). All patients with AAD and patent false lumen had d-dimer levels above the threshold of 400 ng/mL (sensitivity 100%). However, one patient with AIH presented d-dimer levels below the threshold. Therefore, the sensitivity of the d-dimer test in detecting AIH was 90%. CONCLUSIONS: Sta-Liatest D-Di levels are lower in AIH than in AAD with patent false lumen. This test can quite possibly be negative in the case of intramural hematoma. This feature must be considered when interpreting d-dimer levels in patients with acute aortic syndrome.

Radiofrequency catheter ablation of atrial flutter induces the release of platelet and leukocyte-derived procoagulant microparticles and a prothrombotic state.

BACKGROUND: To assess the extent of endothelium, platelet, and leukocyte damage and coagulation activation induced by radiofrequency catheter ablation (RF) of atrial flutter. In the vasculature, procoagulant microparticles (MPs) are reliable markers of vascular damage. They provide an additional phospholipidic surface, enabling the assembly of the enzyme complexes of blood coagulation and consequent thrombin generation. METHODS: MPs were measured in the venous blood of 33 patients with isthmus-dependent atrial flutter undergoing RF before (RF(0)), immediately after (RF(1)), and at day 1 (RF(2)) thereafter. Concentrations of PAI-1, vWF, and D-dimers were simultaneously determined. MPs procoagulant activities were determined using a functional prothrombinase assay. RF induces an early rise of platelet-derived MPs (platelet), vWF Ag, and D-dimers levels, which is concomitant with the decrease of PAI-1 concentrations. Conversely, no significant changes in endothelial-derived MPs could be evidenced. At RF(2), sustained elevation of leukocytes-derived MPs, vWF, and D-dimers testified to an ongoing prothrombotic status. CONCLUSION: RF ablation of common flutter induces a prothrombotic state and the release of platelet and leukocyte-derived procoagulant microparticles. Whereas this activation of blood coagulation could be viewed as clinically marginal in right-sided procedures, its relevance in left-sided procedures should be established.

An ontology-based annotation of cardiac implantable electronic devices to detect therapy changes in a national registry.

The patient population benefitting from cardiac implantable electronic devices (CIEDs) is increasing. This study introduces a device annotation method that supports the consistent description of the functional attributes of cardiac devices and evaluates how this method can detect device changes from a CIED registry. We designed the Cardiac Device Ontology, an ontology of CIEDs and device functions. We annotated 146 cardiac devices with this ontology and used it to detect therapy changes with respect to atrioventricular pacing, cardiac resynchronization therapy, and defibrillation capability in a French national registry of patients with implants (STIDEFIX). We then analyzed a set of 6905 device replacements from the STIDEFIX registry. Ontology-based identification of therapy changes (upgraded, downgraded, or similar) was accurate (6905 cases) and performed better than straightforward analysis of the registry codes (F-measure 1.00 versus 0.75 to 0.97). This study demonstrates the feasibility and effectiveness of ontology-based functional annotation of devices in the cardiac domain. Such annotation allowed a better description and in-depth analysis of STIDEFIX. This method was useful for the automatic detection of therapy changes and may be reused for analyzing data from other device registries.

Cardioinhibition can be the unique manifestation of epilepsy-like syncope.

SUMMARY: Sudden death and syncope remain frequently unexplained despite numerous investigations. Here, we report the case of a pacemaker-implanted patient who presented during video-polysomnography recording a complete atrioventricular block simultaneously with an electrical seizure. Remarkably, the patient was completely asymptomatic. He had a history of recurrent syncope previously diagnosed as convulsive vasovagal syncope with cardioinhibition. This observation challenges the current belief that epilepsy-like syncope is a partial complex seizure systematically characterized by a stereotypical clinical course and ending suddenly with syncope. Physicians should know that syncope, followed by jerking movements, of cardiac origin is frequent and often misdiagnosed as epilepsy. Conversely, and although this is a rare condition, they should also be aware of the possibility of epilepsy-like syncope, even in the absence of any other principle symptoms evocative of epilepsy.

Sustained elevated amounts of circulating procoagulant membrane microparticles and soluble GPV after acute myocardial infarction in diabetes mellitus.

During myocardial infarction (MI), platelet activation and endothelial apoptosis are responsible for the release of procoagulant membrane-derived microparticles (MP) in the blood flow. MP prothrombotic and proinflammatory properties may be crucial for coronary prognosis. Elevated amounts of circulating procoagulant MP were described in diabetes mellitus (DM), and could be of particular significance in a MI context. We evaluated the prothrombotic status of DM and non-DM (NDM) patients at days 1 and 6 after MI, by measurement of circulating procoagulant MP and soluble GPV (sGPV), the platelet glycoprotein V major fragment released upon thrombin cleavage. Variations were compared to values measured in healthy volunteers (HV). Procoagulant MP were captured onto insolubilized annexin V and quantified by prothrombinase assay. Their cellular origin was assessed. With respect to HV, the levels of procoagulant MP detected at D1 and D6 were elevated in DM and NDM, MP being significantly higher in DM vs. NDM. The high amounts of platelet-derived MP and the correlation between procoagulant MP and sGPV, testify to the central role of thrombin-activated platelets during MI in both DM and NDM subsets. The release of platelet and endothelial cell-derived MP persisted at D6 and was more important in DM, the associated prothrombotic risk being also reflected by higher levels of sGPV. The endothelial damage revealed by endothelial-derived MP was twice that observed in NDM patients. In DM patients presenting cardio-vascular events at 6 month follow-up, MP levels were significantly higher at D1 after MI than in those without complication (24.9 +/- 4.8 vs. 12.3 +/- 2.7 nM PhtdSer, p = 0.02), suggesting a prognostic potential for MP.