Leadless pacemaker implantation following tricuspid interventions: multicenter collaboration of feasibility and safety.

BACKGROUND: Permanent pacing is often required following valve intervention (either surgical or percutaneous); however, tricuspid interventions pose specific challenges to conventional pacing. Therefore, leadless pacemaker (LP) implantation may be the preferred strategy when permanent pacing is required after tricuspid valve intervention. PURPOSE: To report periprocedural outcomes and follow-up of patients undergoing implantation of a LP system following tricuspid valve interventions. METHODS: Patients with previous tricuspid valve intervention at the time of attempted implantation of a LP (MicraTM, Medtronic, Minneapolis, MN, USA) were included. RESULTS: Between 2019 and 2022, 40 patients underwent LP implantations following tricuspid interventions in 5 large tertiary centers. The mean age was 68.9 ± 13.7 years, and 48% patients were male. The indication for pacing was as following: AVB in 27 (68%) patients, AF with slow ventricular response in 10 (25%) patients, and refractory rapid atrial fibrillation (AF) referred to AV junction ablation in 3 (7%) patients. Most of the patients received Micra VR (78%). The procedure was successful in all patients. The mean procedural time is 58 ± 32 min, and the median fluoroscopy time is 7.5 min. Electrical parameters were within normal range (threshold: 1.35 ± 1.2 V@0.24 ms, impedance: 772 ± 245 Ohm, R-wave: 6.9 ± 5.4 mV). No acute complications were observed. During a mean follow-up of 10 months, electrical parameters remained stable, and 4 deaths were occurred (not related to the procedure). CONCLUSION: A LP is a safe and efficient option following tricuspid valve interventions.

Patterns of comorbidities in patients with atrial fibrillation and impact on management and long-term prognosis: an analysis from the Prospective Global GLORIA-AF Registry.

BACKGROUND: Clinical complexity, as the interaction between ageing, frailty, multimorbidity and polypharmacy, is an increasing concern in patients with AF. There remains uncertainty regarding how combinations of comorbidities influence management and prognosis of patients with atrial fibrillation (AF). We aimed to identify phenotypes of AF patients according to comorbidities and to assess associations between comorbidity patterns, drug use and risk of major outcomes. METHODS: From the prospective GLORIA-AF Registry, we performed a latent class analysis based on 18 diseases, encompassing cardiovascular, metabolic, respiratory and other conditions; we then analysed the association between phenotypes of patients and (i) treatments received and (ii) the risk of major outcomes. Primary outcome was the composite of all-cause death and major adverse cardiovascular events (MACE). Secondary exploratory outcomes were also analysed. RESULTS: 32,560 AF patients (mean age 70.0 ± 10.5 years, 45.4% females) were included. We identified 6 phenotypes: (i) low complexity (39.2% of patients); (ii) cardiovascular (CV) risk factors (28.2%); (iii) atherosclerotic (10.2%); (iv) thromboembolic (8.1%); (v) cardiometabolic (7.6%) and (vi) high complexity (6.6%). Higher use of oral anticoagulants was found in more complex groups, with highest magnitude observed for the cardiometabolic and high complexity phenotypes (odds ratio and 95% confidence interval CI): 1.76 [1.49-2.09] and 1.57 [1.35-1.81], respectively); similar results were observed for beta-blockers and verapamil or diltiazem. We found higher risk of the primary outcome in all phenotypes, except the CV risk factor one, with highest risk observed for the cardiometabolic and high complexity groups (hazard ratio and 95%CI: 1.37 [1.13-1.67] and 1.47 [1.24-1.75], respectively). CONCLUSIONS: Comorbidities influence management and long-term prognosis of patients with AF. Patients with complex phenotypes may require comprehensive and holistic approaches to improve their prognosis.

Mitral transcatheter edge-to-edge repair vs. isolated mitral surgery for severe mitral regurgitation: a French nationwide study.

BACKGROUND AND AIMS: Mitral valve surgery and, more recently, mitral transcatheter edge-to-edge repair (TEER) are the two treatments of severe mitral regurgitation in eligible patients. Clinical comparison of both therapies remains limited by the number of patients analysed. The objective of this study was to analyse the outcomes of mitral TEER vs. isolated mitral valve surgery at a nationwide level in France. METHODS: Based on the French administrative hospital discharge database, the study collected information for all consecutive patients treated for mitral regurgitation with isolated TEER or isolated mitral valve surgery between 2012 and 2022. Propensity score matching was used for the analysis of outcomes. RESULTS: A total of 57 030 patients were found in the database. After matching on baseline characteristics, 2160 patients were analysed in each arm. At 3-year follow-up, TEER was associated with significantly lower incidence of cardiovascular death (hazard ratio 0.685, 95% confidence interval 0.563-0.832; P = .0001), pacemaker implantation, and stroke. Non-cardiovascular death (hazard ratio 1.562, 95% confidence interval 1.238-1.971; P = .0002), recurrent pulmonary oedema, and cardiac arrest were more frequent after TEER. No significant differences between the two groups were observed regarding all-cause death (hazard ratio 0.967, 95% confidence interval 0.835-1.118; P = .65), endocarditis, major bleeding, atrial fibrillation, and myocardial infarction. CONCLUSIONS: Our results suggest that TEER for severe mitral regurgitation was associated with lower cardiovascular mortality than mitral surgery at long-term follow-up. Pacemaker implantation and stroke were less frequently observed after TEER.

Epilepsy and the risk of adverse cardiovascular events: A nationwide cohort study.

BACKGROUND AND PURPOSE: Epilepsy is associated with higher morbidity and mortality compared to people without epilepsy. We performed a retrospective cross-sectional and longitudinal cohort study to evaluate cardiovascular comorbidity and incident vascular events in people with epilepsy (PWE). METHODS: Data were extracted from the French Hospital National Database. PWE (n = 682,349) who were hospitalized between January 2014 and December 2022 were matched on age, sex, and year of hospitalization with 682,349 patients without epilepsy. Follow-up was conducted from the date of first hospitalization with epilepsy until the date of each outcome or date of last news in the absence of the outcome. Primary outcome was the incidence of all-cause death, cardiovascular death, myocardial infarction, hospitalization for heart failure, ischaemic stroke (IS), new onset atrial fibrillation, sustained ventricular tachycardia or fibrillation (VT/VF), and cardiac arrest. RESULTS: A diagnosis of epilepsy was associated with higher numbers of cardiovascular risk factors and adverse cardiovascular events compared to controls. People with epilepsy had a higher incidence of all-cause death (incidence rate ratio [IRR] = 2.69, 95% confidence interval [CI] = 2.67-2.72), cardiovascular death (IRR = 2.16, 95% CI = 2.11-2.20), heart failure (IRR = 1.26, 95% CI = 1.25-1.28), IS (IRR = 2.08, 95% CI = 2.04-2.13), VT/VF (IRR = 1.10, 95% CI = 1.04-1.16), and cardiac arrest (IRR = 2.12, 95% CI = 2.04-2.20). When accounting for all-cause death as a competing risk, subdistribution hazard ratios for ischaemic stroke of 1.59 (95% CI = 1.55-1.63) and for cardiac arrest of 1.73 (95% CI = 1.58-1.89) demonstrated higher risk in PWE. CONCLUSIONS: The prevalence and incident rates of cardiovascular outcomes were significantly higher in PWE. Targeting cardiovascular health could help reduce excess morbidity and mortality in PWE.

Pre-emptive treatment of heart failure exacerbations in patients managed with the HeartLogic™ algorithm.

AIMS: Heart failure (HF) is a chronic disease affecting 64 million people worldwide and places a severe burden on society because of its mortality, numerous re-hospitalizations and associated costs. HeartLogic™ is an algorithm programmed into implanted devices incorporating several biometric parameters which aims to predict HF episodes. It provides an index which can be monitored remotely, allowing pre-emptive treatment of congestion to prevent acute decompensation. We aim to assess the impact and security of pre-emptive HF management, guided by the HeartLogic™ index. METHODS AND RESULTS: The HeartLogic™ France Cohort Study is an investigator-initiated, prospective, multi-centre, non-randomized study. Three hundred ten patients with a history of HF (left ventricular ejection fraction ≤40%; or at least one episode of clinical HF with elevated NT-proBNP ≥450 ng/L) and implanted with a cardioverter defibrillator enabling HeartLogic™ index calculation will be included across 10 French centres. The HeartLogic™ index will be monitored remotely for 12 months and in the event of a HeartLogic™ index ≥16, the local investigator will contact the patient for assessment and adjust HF treatment as necessary. The primary endpoint is unscheduled hospitalization for HF. Secondary endpoints are all-cause mortality, cardiovascular death, HF-related death, unscheduled hospitalizations for ventricular or atrial arrhythmia and HeartLogic™ index evolution over time. Blood samples will be collected for biobanking, and quality of life will be assessed. Finally, the safety of a HeartLogic™-triggered strategy for initiating or increasing diuretic therapy will be assessed. A blind and independent committee will adjudicate the events. CONCLUSIONS: The HeartLogic™ France Cohort Study will provide robust real-world data in a cohort of HF patients managed with the HeartLogic™ algorithm allowing pre-emptive treatment of heart failure exacerbations.

Silent pulmonary veins at redo ablation for atrial fibrillation: Implications and approaches.

BACKGROUND: Pulmonary vein isolation (PVI) is the cornerstone of atrial fibrillation (AF) ablation. Despite promising success rates, redo ablation is sometimes required. At redo, PVs may be found to be isolated (silent) or reconnected. We studied patients with silent vs reconnected PVs at redo and analysed associations with adverse outcomes. METHODS: Patients undergoing redo AF ablations between 2013 and 2019 at our institution were included and stratified into silent PVs or reconnected PVs. The primary outcome was a composite of further redo ablation, non-AF ablation, atrioventricular nodal ablation, and death. Secondary outcomes included arrhythmia recurrence. RESULTS: A total of 467 patients were included with mean 4.6 ± 1.7 years follow-up, of whom 48 (10.3%) had silent PVs. The silent PV group had had more often undergone >1 prior ablation (45.8% vs 9.8%; p<0.001), had more persistent AF (62.5% vs 41.1%; p=0.005) and had more non-PV ablation performed both at prior ablation procedures and at the analysed redo ablation. The primary outcome occurred more frequently in those with silent PVs (25% vs 13.8%; p=0.053). Arrhythmia recurrence was also more common in the silent PV group (66.7% vs 50.6%; p=0.047). After multivariable adjustment, female sex (aHR 2.35 [95% CI 2.35-3.96]; p=0.001) and ischaemic heart disease (aHR 3.21 [95% CI 1.56-6.62]; p=0.002) were independently associated with the primary outcome, and left atrial enlargement (aHR 1.58 [95% CI 1.20-2.08]; p=0.001) and >1 prior ablation (aHR 1.88 [95% CI 1.30-2.72]; p<0.001) were independently associated with arrhythmia recurrence. Whilst a finding of silent PVs was not itself significant after multivariable adjustment, this provides an easily assessable parameter at clinically indicated redo ablation which informs the clinician of the likelihood of a worse future prognosis. CONCLUSIONS: Patients with silent PVs at redo AF ablation have worse clinical outcomes.

Metabolically 'extremely unhealthy' obese and non-obese patients with diabetes and the risk of cardiovascular events: a French nationwide cohort study.

BACKGROUND: Non-obese patients with diabetes mellitus (DM) are becoming more prevalent, but their cardiovascular risk (CV) especially when accompanied with cardio-renal-metabolic co-morbidities (hypertension, chronic kidney disease, hyperlipidemia) is not well characterised. The aim of the study was to assess the CV risk among patients with DM in relation to obesity and cardio-renal-metabolic co-morbidities. MATERIALS AND METHODS: This was a cohort study of all patients with DM without a history of major adverse cardiovascular event who were hospitalized for any reason in France in 2013 with at least 5 years of follow-up. They were categorized by the presence of obesity vs no obesity, as well as three cardio-renal-metabolic co-morbidities: hypertension, chronic kidney disease, hyperlipidemia. 'Extremely unhealthy' patients with DM were defined as those having all 3 co-morbidities. RESULTS: There were 196,112 patients (mean age 65.7 (SD 13.7) years; 54.3% males) included into the analysis. During a mean follow-up of 4.69 ± 1.79 years, when adjusted for multiple covariates, the non-obese and 'extremely unhealthy' obese patients had the highest risk of CV death [aHR 1.40 (95% CI, 1.22-1.61) and 1.48 (95% CI, 1.25-1.75), respectively]. The 'extremely unhealthy' obese had the highest risk of MACE-HF [aHR 1.84 (95% CI, 1.72-1.97)] and new-onset AF [aHR 1.64 (95% CI, 1.47-1.83)]. CONCLUSION: Both non-obese and obese patients with DM with associated cardio-renal-metabolic co-morbidities are an 'extremely unhealthy' phenotype with the highest risk of CV death and CV events.

Patterns of oral anticoagulant use and outcomes in Asian patients with atrial fibrillation: a post-hoc analysis from the GLORIA-AF Registry.

Background: Previous studies suggested potential ethnic differences in the management and outcomes of atrial fibrillation (AF). We aim to analyse oral anticoagulant (OAC) prescription, discontinuation, and risk of adverse outcomes in Asian patients with AF, using data from a global prospective cohort study. Methods: From the GLORIA-AF Registry Phase II-III (November 2011-December 2014 for Phase II, and January 2014-December 2016 for Phase III), we analysed patients according to their self-reported ethnicity (Asian vs. non-Asian), as well as according to Asian subgroups (Chinese, Japanese, Korean and other Asian). Logistic regression was used to analyse OAC prescription, while the risk of OAC discontinuation and adverse outcomes were analysed through Cox-regression model. Our primary outcome was the composite of all-cause death and major adverse cardiovascular events (MACE). The original studies were registered with ClinicalTrials.gov, NCT01468701, NCT01671007, and NCT01937377. Findings: 34,421 patients were included (70.0 ± 10.5 years, 45.1% females, 6900 (20.0%) Asian: 3829 (55.5%) Chinese, 814 (11.8%) Japanese, 1964 (28.5%) Korean and 293 (4.2%) other Asian). Most of the Asian patients were recruited in Asia (n = 6701, 97.1%), while non-Asian patients were mainly recruited in Europe (n = 15,449, 56.1%) and North America (n = 8378, 30.4%). Compared to non-Asian individuals, prescription of OAC and non-vitamin K antagonist oral anticoagulant (NOAC) was lower in Asian patients (Odds Ratio [OR] and 95% Confidence Intervals (CI): 0.23 [0.22-0.25] and 0.66 [0.61-0.71], respectively), but higher in the Japanese subgroup. Asian ethnicity was also associated with higher risk of OAC discontinuation (Hazard Ratio [HR] and [95% CI]: 1.79 [1.67-1.92]), and lower risk of the primary composite outcome (HR [95% CI]: 0.86 [0.76-0.96]). Among the exploratory secondary outcomes, Asian ethnicity was associated with higher risks of thromboembolism and intracranial haemorrhage, and lower risk of major bleeding. Interpretation: Our results showed that Asian patients with AF showed suboptimal thromboembolic risk management and a specific risk profile of adverse outcomes; these differences may also reflect differences in country-specific factors. Ensuring integrated and appropriate treatment of these patients is crucial to improve their prognosis. Funding: The GLORIA-AF Registry was funded by Boehringer Ingelheim GmbH.

Outcomes in Patients with Acute Myocardial Infarction and Known Sleep Apnea: A Nationwide Analysis.

Background. Sleep apnea (SA) is a common breathing disorder characterized by repetitive upper airway narrowing and closure. Although SA has been demonstrated to be an independent risk factor for all-cause mortality, the direct contribution of SA to worse cardiovascular prognosis may be difficult to evaluate, and its independent association with the different types of cardiovascular outcomes may be debated, particularly in the context of patients with acute myocardial infarction (AMI). The aim of this study was to assess the impact of known SA on the outcomes of hospitalized patients who have had an AMI by analyzing 10-year data collected from a national registry. Methods. This longitudinal cohort study was based on the national hospitalization database that covers hospital care for the entire French population, including all patients admitted with AMI from January 2010 to June 2019. The clinical outcomes for the analysis were as follows: all-cause death, cardiovascular death, ischemic stroke, new-onset atrial fibrillation (FA), and re-hospitalization for heart failure (HF). Results. Among the 797,212 patients who presented with an AMI (528,351 men and 268,861 women), 37,075 (4.7%) had documented SA. During follow-up (mean [SD] 1.8 [2.4] years, median [interquartile range] 0.7 [0.1-3.1] years), 163,845 deaths (of which 85,649 were cardiovascular deaths), 20,168 ischemic strokes, 58,498 new-onset AF, and 92,381 rehospitalizations due to HF were recorded. Patients with known SA had a worse prognosis in the short and medium term, but after adjusting for all covariables, SA was only independently associated with a higher risk of rehospitalization for HF and new-onset AF in men and women. Conclusion. Data from our large nationwide analysis confirm that known SA is associated with poor cardiovascular outcomes in patients who have had an AMI. However, this impact is tem-pered when the model is adjusted for age, cardiovascular risk, or other covariables. Further studies need to be conducted to assess the independent impact of SA on the prognosis of patients with AMI.

Prediction of early death after atrial fibrillation diagnosis using a machine learning approach: A French nationwide cohort study.

AIMS: Atrial fibrillation is associated with important mortality but the usual clinical risk factor based scores only modestly predict mortality. This study aimed to develop machine learning models for the prediction of death occurrence within the year following atrial fibrillation diagnosis and compare predictive ability against usual clinical risk scores. METHODS AND RESULTS: We used a nationwide cohort of 2,435,541 newly diagnosed atrial fibrillation patients seen in French hospitals from 2011 to 2019. Three machine learning models were trained to predict mortality within the first year using a training set (70% of the cohort). The best model was selected to be evaluated and compared with previously published scores on the validation set (30% of the cohort). Discrimination of the best model was evaluated using the C index. Within the first year following atrial fibrillation diagnosis, 342,005 patients (14.4%) died after a period of 83 (SD 98) days (median 37 [10-129]). The best machine learning model selected was a deep neural network with a C index of 0.785 (95% CI, 0.781-0.789) on the validation set. Compared to clinical risk scores, the selected model was superior to the CHA2DS2-VASc and HAS-BLED risk scores and superior to dedicated scores such as Charlson Comorbidity Index and Hospital Frailty Risk Score to predict death within the year following atrial fibrillation diagnosis (C indexes: 0.597; 0.562; 0.643; 0.626 respectively. P < .0001). CONCLUSION: Machine learning algorithms predict early death after atrial fibrillation diagnosis and may help clinicians to better risk stratify atrial fibrillation patients at high risk of mortality.

Atrial Fibrillation Associated with Heart Failure: Perspectives from Recent Large Clinical Studies and Translational Research.

Atrial fibrillation (AF) is a major public health issue [...].

Phenotypes and outcomes in non-anticoagulated patients with atrial fibrillation: An unsupervised cluster analysis.

BACKGROUND: Patients with atrial fibrillation are characterized by great clinical heterogeneity and complexity. The usual classifications may not adequately characterize this population. Data-driven cluster analysis reveals different possible patient classifications. AIMS: To identify different clusters of patients with atrial fibrillation who share similar clinical phenotypes, and to evaluate the association between identified clusters and clinical outcomes, using cluster analysis. METHODS: An agglomerative hierarchical cluster analysis was performed in non-anticoagulated patients from the Loire Valley Atrial Fibrillation cohort. Associations between clusters and a composite outcome comprising stroke/systemic embolism/death and all-cause death, stroke and major bleeding were evaluated using Cox regression analyses. RESULTS: The study included 3434 non-anticoagulated patients with atrial fibrillation (mean age 70.3±17 years; 42.8% female). Three clusters were identified: cluster 1 was composed of younger patients, with a low prevalence of co-morbidities; cluster 2 included old patients with permanent atrial fibrillation, cardiac pathologies and a high burden of cardiovascular co-morbidities; cluster 3 identified old female patients with a high burden of cardiovascular co-morbidities. Compared with cluster 1, clusters 2 and 3 were independently associated with an increased risk of the composite outcome (hazard ratio 2.85, 95% confidence interval 1.32-6.16 and hazard ratio 1.52, 95% confidence interval 1.09-2.11, respectively) and all-cause death (hazard ratio 3.54, 95% confidence interval 1.49-8.43 and hazard ratio 1.88, 95% confidence interval 1.26-2.79, respectively). Cluster 3 was independently associated with an increased risk of major bleeding (hazard ratio 1.72, 95% confidence interval 1.06-2.78). CONCLUSION: Cluster analysis identified three statistically driven groups of patients with atrial fibrillation, with distinct phenotype characteristics and associated with different risks for major clinical adverse events.

Characteristics and Prognosis of Patients With Hypertensive Encephalopathy: A French Nationwide Cohort Study.

BACKGROUND: Hypertensive encephalopathy (HE) constitutes a serious condition, usually observed in patients with long-lasting hypertension. Hypertension-associated HE is sometimes differentiated from the stroke-associated hypertensive emergency. Whether prognosis of hypertension-associated and stroke-associated HE is different is unclear. METHODS: Characteristics and prognosis of HE were assessed in this nationwide retrospective cohort study in all patients with an administrative code of HE compared with age-, sex- and year of inclusion-matched controls admitted to French hospitals during the 2014 to 2022 period. RESULTS: HE was identified in 7769 patients. Chronic kidney disease (19.3%), coronary artery disease (13.8%), diabetes (22.1%), and ischemic stroke (5.2%) were frequent but thrombotic microangiopathy, hemolytic-uremic syndrome, systemic sclerosis or renal infarction were <1%. HE prognosis was poor (death: 10.4%/y, heart failure: 8.6%/y, end-stage kidney disease: 9.0%/y, ischemic stroke: 3.6%/y, hemorrhagic stroke: 1.6%/y, dementia: 4.1%/y). The risk of death was increased to a similar extent in patients with HE, regardless of the presence of known hypertension or concomitant stroke (versus patients without HE). Among patients with HE, known hypertension was significantly associated with increased risks of ischemic stroke, hemorrhagic stroke, heart failure, vascular dementia, and all-cause dementia and to a lesser extent with chronic dialysis in multivariable analyses including adjustment on concomitant stroke. CONCLUSIONS: HE remains a considerable health burden and is associated with a poor prognosis. The distinction between hypertension- versus stroke-associated HE is relevant as these 2 situations convey different risks of stroke, heart failure, vascular dementia, and end-stage kidney disease.

Comparison of first- and second-generation leadless pacemakers in patients with sinus rhythm and complete atrioventricular block.

INTRODUCTION: The efficacy and safety of leadless cardiac pacemakers (LPMs) as an alternative to conventional transvenous cardiac pacing have been largely reported. The first generation of the MicraTM transcatheter pacing system (VR; Medtronic) was able to provide single-chamber VVI(R) pacing mode only, with a potential risk of pacemaker syndrome in sinus rhythm patients. A second-generation system (AV) now provides atrioventricular synchrony through atrial mechanical (Am) sensing capability (VDD mode). OBJECTIVE: We sought to compare VR and AV systems in sinus rhythm patients with chronic ventricular pacing (Vp) for complete atrioventricular block. METHODS: All consecutive patients implanted with an LPM in our department for complete atrioventricular block were retrospectively screened. Patients with atrial fibrillation, sinus dysfunction, or Vp burden <20% at 1 month postimplantation were excluded. Patients were systematically followed with a visit at 1 month, and then at least once a year. RESULTS: A total of 93 patients-45 VR (2015-2020) and 48 AV (2020-2021)-were included. VR and AV patients had similar baseline characteristics, except for VR patients being older (80 ± 8 vs. 77 ± 9 years, p = 0.049). The mean Vp burden was 77% in the VR and 82% in the AV group (p = 0.38). In AV patients, the median AV synchronous beats rate was 78%, with 65% having a >66% rate. An E/A ratio <1.2 as measured on echocardiography was the only independent predictor of accurate atrial mechanical tracking (p = 0.01). One-year survival rate was similar in both groups. Five patients in the VR and 0 in the AV group eventually developed pacemaker syndrome within 1 year post-implantation (p = 0.02). CONCLUSION: In sinus rhythm patients with chronic Vp for complete atrioventricular block implanted with an LPM, the atrial mechanical sensing algorithm allowed significant atrioventricular synchrony in most patients and was associated with no occurrence of-otherwise rare-pacemaker syndrome.

Ventricular arrhythmias and cardiac arrest in atrial fibrillation patients with pacemakers and implantable cardioverter-defibrillators.

BACKGROUND: Atrial fibrillation (AF) has been linked to ventricular arrhythmias (VAs) and sudden death, but few studies have specifically explored this association. OBJECTIVE: We investigated whether AF is associated with an increased risk of ventricular tachycardia (VT), ventricular fibrillation (VF) and cardiac arrests (CA) in patients with cardiac implantable electronic devices (CIEDs). METHODS: All patients with pacemakers and implantable cardioverter-defibrillators (ICDs) hospitalised between 2010 and 2020 were identified from the French National database. Patients with a prior history of VT/VF/CA were excluded. RESULTS: 701,195 patients were identified initially. After excluding 55,688 patients, 581,781 (90.1%) and 63,726 (9.9%) remained in the pacemaker and ICD groups respectively. 248,046 (42.6%) pacemaker patients had AF and 333,735 (57.4%) had no AF, whereas in the ICD group 20,965 (32.9%) had AF and 42,761 (67.1%) had no AF. The incidence of VT/VF/CA was higher in AF patients compared to non-AF patients both in pacemaker (1.47%/year vs. 0.94%/year) and ICD (5.30%/year vs. 4.21%/year) groups. After multivariable analysis, AF was independently associated with an increased risk of VT/VF/CA in pacemaker (HR 1.236 [95% CI 1.198-1.276]) and ICD (HR 1.167 [95% CI 1.111-1.226]) patients. This risk was still significant in the 1:1 propensity score-matched analysis of the pacemaker (n = 200,977 per subgroup) and ICD cohorts (n = 18,349 per subgroup), HR 1.230 [95% CI 1.187-1.274] and HR 1.134 [95% CI 1.071-1.200] respectively and in the competing risk analysis (pacemaker: HR 1.195 (95% CI 1.154-1.238], ICD: HR 1.094 [95% CI 1.034-1.157]). CONCLUSION: CIED patients with AF have a higher risk of VT/VF/CA compared to CIED patients without AF.

A Universal Bleeding Risk Score in Native and Allograft Kidney Biopsies: A French Nationwide Cohort Study.

BACKGROUND: The risk of bleeding after percutaneous biopsy in kidney transplant recipients is usually low but may vary. A pre-procedure bleeding risk score in this population is lacking. METHODS: We assessed the major bleeding rate (transfusion, angiographic intervention, nephrectomy, hemorrhage/hematoma) at 8 days in 28,034 kidney transplant recipients with a kidney biopsy during the 2010-2019 period in France and compared them to 55,026 patients with a native kidney biopsy as controls. RESULTS: The rate of major bleeding was low (angiographic intervention: 0.2%, hemorrhage/hematoma: 0.4%, nephrectomy: 0.02%, blood transfusion: 4.0%). A new bleeding risk score was developed (anemia = 1, female gender = 1, heart failure = 1, acute kidney failure = 2 points). The rate of bleeding varied: 1.6%, 2.9%, 3.7%, 6.0%, 8.0%, and 9.2% for scores 0 to 5, respectively, in kidney transplant recipients. The ROC AUC was 0.649 (0.634-0.664) in kidney transplant recipients and 0.755 (0.746-0.763) in patients who had a native kidney biopsy (rate of bleeding: from 1.2% for score = 0 to 19.2% for score = 5). CONCLUSIONS: The risk of major bleeding is low in most patients but indeed variable. A new universal risk score can be helpful to guide the decision concerning kidney biopsy and the choice of inpatient vs. outpatient procedure both in native and allograft kidney recipients.

Leadless cardiac pacing: Results from a large single-centre experience.

BACKGROUND: The efficacy and safety of leadless cardiac pacing as an alternative to conventional transvenous cardiac pacing in selected patients have been widely reported. AIM: To report the experience of a high-volume implantation centre with older and new generations of leadless pacemakers. METHODS: This retrospective observational study included the first consecutive 400 patients who underwent implantation of a leadless pacemaker in our centre. Complications and electrical parameters were evaluated during follow-up, comparing patients implanted with first-generation (Micra™ VR) and second-generation (Micra™ AV) leadless pacemakers (Medtronic, Minneapolis, MN, USA). Data were collected by a review of medical files. RESULTS: Among 400 procedures, there were 328 Micra™ VR pacemakers and 72 Micra™ AV pacemakers implanted, followed for a median of 16 months (694 patient-years). The mean age was 77 years and both groups had a high burden of co-morbidities. Implantation success rate was 99.5%. A total of 87.5% of patients were discharged the day after the procedure. The pacing threshold remained stable and<2V in 96.5% of all patients. The perioperative complication rate at 30 days was 3.5%. Outcomes were similar between the two groups. CONCLUSION: Leadless cardiac pacing is a safe and efficient alternative to conventional transvenous cardiac pacing.

Clinical Phenotypes and Atrial Fibrillation Recurrences After Catheter Ablation: An Unsupervised Cluster Analysis.

Catheter ablation (CA) is a well-established treatment of atrial fibrillation (AF). Data-driven cluster analysis is able to better distinguish prognostically-relevant phenotype clusters among patients with AF. We performed a hierarchical cluster analysis in a cohort of AF patients undergoing a first CA and evaluate associations between identified clusters and recurrences of arrhythmia following ablation. The study included 209 AF patients treated with CA. A total of 3 clusters with distinct characteristics were identified. Recurrences at 1 year occurred in 27.2% in Cluster 1, 43.2% in Cluster 2 and 60.9% in Cluster 3 (P < 0.0001). Cluster classification was independently associated with arrhythmia recurrences (HR 1.58, 95% CI 1.01-2.49, P = 0.046) after adjustment for age, CHA2DS2-VASc score, left atrial volume, type of atrial fibrillation and ejection fraction. To concluded, cluster analysis identified 3 statistically-driven groups among AF patients treated with CA with different risks for arrhythmia recurrences.

T Waves May Not Be What They Seem!

A 39-year-old women who received a transvenous dual-chamber pacemaker in childhood developed 20 years later severe tricuspid valve stenosis induced by the leads and worsened by a pseudo-pacemaker syndrome. (Level of Difficulty: Intermediate.).