Outcomes Associated With Left Atrial Appendage Occlusion Via Implanted Device in Atrial Fibrillation.

OBJECTIVE: To compare outcomes after left atrial appendage occlusion (LAAO) via implanted device vs no LAAO in a matched cohort of patients with atrial fibrillation (AF). METHODS: This longitudinal retrospective cohort study was based on the national database covering hospital care for the entire French population. Adults (≥18 years of age) who had been hospitalized with AF (January 1, 2015, to January 1, 2020) who underwent LAAO were identified. Propensity score matching was used to control for potential confounders of the treatment-outcome relationship. The primary outcome was a composite of ischemic stroke, major bleeding, or all-cause death during follow-up. RESULTS: After propensity score matching, 1216 patients with AF who were treated with LAAO were matched with 1216 controls (patients AF who were not treated with LAAO). Mean follow-up was 14.5 months (median, 13 months; IQR, 7-21 months). Patients with LAAO had a lower risk of the composite outcome (HR, 0.48; 95% CI, 0.42 to 0.55). Total events (309 for LAAO vs 640 for controls) and event rates (23.3% vs 44.0%/year, respectively) were lower for LAAO, driven primarily by a decreased risk of all-cause death (HR, 0.39; 95% CI, 0.33 to 0.46; P<.0001), whereas ischemic stroke risk was higher (HR, 1.75; 95% CI, 1.17 to 2.64). Significant interactions were observed in subgroups with a history of ischemic stroke (P<.001) and of bleeding (P=.002). CONCLUSION: Among AF patients at high bleeding risk, our nationwide study highlights a high risk of clinical events during follow-up. LAAO appeared less effective than no LAAO in preventing stroke but more effective in preventing death. Left atrial appendage occlusion is particularly effective in patients with previous ischemic stroke or any episode of bleeding.

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.

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.

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.

Type 2 diabetes and cardiorenal syndromes. A nationwide French hospital cohort study.

AIM: Type 2 diabetes mellitus (T2DM) is a risk factor for cardiac and renal complications; its effect on cardiorenal syndromes is unknown. METHODS: In a French nationwide cohort of 5,123,193 patients hospitalized in 2012 with ≥5 years of follow-up, we assessed the effect of T2DM on cardiorenal syndrome (CRS) (using cardiorenal, renocardiac, and simultaneous subtypes) incidence and outcomes using 1:1 propensity matching. RESULTS: Among 4,605,236 adults without cardiorenal syndrome, 380,581 (8.5%) with T2DM were matched to 380,581 adults without T2DM. During follow-up, CRS occurred in 104,788 patients: simultaneous n = 25,225 (24.0%); cardiorenal n = 51,745 (49.4%); renocardiac n = 27,818 (26.5%). T2DM doubled the risk of incident CRS (1.30% versus 0.65%/year; adjusted hazard ratio (HR) for any cardiorenal syndrome: 2.14 [95% confidence interval 2.10;2.19]; renocardiac: 2.43 [2.34;2.53]; cardiorenal: 2.09 [2.03;2.15]; simultaneous: 1.94 [1.86;2.03]. Among the 26,396 adults with CRS in 2012, 11,355 (43.0%) had T2DM and were younger than non-diabetic adults (77.4 ± 9.5 versus 82.3 ± 10.0); 8,314 patients with T2DM were matched to 8,314 patients without. T2DM increased risk of: end-stage kidney disease, adjusted HR 1.50 [1.39;1.62]; myocardial infarction 1.35 [1.19;1.53]; cardiovascular death 1.20 [1.13;1.27]; heart failure 1.17 [1.12;1.21]; and all-cause death 1.09 [1.06;1.13], but not ischemic stroke. CONCLUSION: Patients with T2DM represent almost half of patients with CRS and are younger than their non-diabetic counterparts. T2DM doubles the risk of CRS and increases the risk of death, cardiovascular outcome, and end-stage kidney disease but not ischemic stroke after CRS.

Incidence of clinical atrial fibrillation and related complications using a screening algorithm at a nationwide level.

AIMS: In a recent position paper, the European Heart Rhythm Association (EHRA) proposed an algorithm for the screening and management of arrhythmias using digital devices. In patients with prior stroke, a systematic screening approach for atrial fibrillation (AF) should always be implemented, preferably immediately after the event. Patients with increasing age and with specific cardiovascular or non-cardiovascular comorbidities are also deemed to be at higher risk. From a large nationwide database, the aim was to analyse AF incidence rates derived from this new EHRA algorithm. METHODS AND RESULTS: Using the French administrative hospital discharge database, all patients hospitalized in 2012 without a history of AF, and with at least a 5-year follow-up (FU) (or if they died earlier), were included. The yearly incidence of AF was calculated in each subgroup defined by the algorithm proposed by EHRA based on a history of previous stroke, increasing age, and eight comorbidities identified via International Classification of Diseases 10th Revision codes. Out of the 4526 104 patients included (mean age 58.9 ± 18.9 years, 64.5% women), 1% had a history of stroke. Among those with no history of stroke, 18% were aged 65-74 years and 21% were ≥75 years. During FU, 327 012 patients had an incidence of AF (yearly incidence 1.86% in the overall population). Implementation of the EHRA algorithm divided the population into six risk groups: patients with a history of stroke (group 1); patients > 75 years (group 2); patients aged 65-74 years with or without comorbidity (groups 3a and 3b); and patients < 65 years with or without comorbidity (groups 4a and 4b). The yearly incidences of AF were 4.58% per year (group 2), 6.21% per year (group 2), 3.50% per year (group 3a), 2.01% per year (group 3b), 1.23% per year (group 4a), and 0.35% per year (group 4b). In patients aged < 65 years, the annual incidence of AF increased progressively according to the number of comorbidities from 0.35% (no comorbidities) to 9.08% (eight comorbidities). For those aged 65-75 years, the same trend was observed, i.e. increasing from 2.01% (no comorbidities) to 11.47% (eight comorbidities). CONCLUSION: These findings at a nationwide scale confirm the relevance of the subgroups in the EHRA algorithm for identifying a higher risk of AF incidence, showing that older patients (>75 years, regardless of comorbidities) have a higher incidence of AF than those with prior ischaemic stroke. Further studies are needed to evaluate the usefulness of algorithm-based risk stratification strategies for AF screening and the impact of screening on major cardiovascular event rates.

Prevalence and incidence of cardiovascular and renal diseases in type 1 compared with type 2 diabetes: A nationwide French observational study of hospitalized patients.

BACKGROUND: Type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) increase risks of cardiovascular (CV) and renal disease compared with diabetes-free populations. There are only a few studies comparing T1DM and T2DM for the relative risk of these clinical events. METHODS: All adult patients hospitalized in French hospitals in 2013 with at least 5 years of follow-up were identified and categorized by their diabetes status. A total of 50,623 patients with T1DM (age 61.4 ± 18.6, 53% male) and 425,207 patients with T2DM (age 68.6 ± 14.3, 55% male) were followed over a median period of 5.3 years (interquartile range: 2.8 - 5.8 years). Prevalence and event rates of myocardial infarction (MI), heart failure (HF), ischemic stroke, chronic kidney disease (CKD), all-cause death and CV death were assessed with age stratification of 10-year intervals. For clinical events during follow-up, we report hazard ratios (HRs) in T1DM relative to T2DM. RESULTS: The age and sex-adjusted prevalence of CV diseases was higher in T2DM for ages above 40 years whereas the prevalence of CKD was more common in T1DM between ages 18 and 70 years. During 2,033,239 person-years of follow-up, age and sex-adjusted HR event rates comparing T1DM, versus T2DM as reference, showed that MI and HF relative risks were increased above 60 years (1.2 and 1.4 -fold). HR of ischemic stroke did not markedly differ between T1DM and T2DM. Risk of incident CKD was 2.4-fold higher in T1DM above 60 years. All-cause death HR risk was 1.1-fold higher in T1DM after 60 years and the CV death risk was 1.15-fold higher in T1DM between 60 and 69 years compared to T2DM. CONCLUSIONS: Although the crude prevalent burden of CV diseases may be lower in T1DM than in T2DM, patients with T1DM may have a higher risk of incident MI, HF, all-cause death and CV death above 60 years of age, highlighting the need for improved prevention in this population.

Atrial Fibrillation and the Risk of Ventricular Arrhythmias and Cardiac Arrest: A Nationwide Population-Based Study.

BACKGROUND: Atrial fibrillation (AF) has been linked to an increased risk of ventricular arrhythmias (VAs) and sudden death. We investigated this association in hospitalised patients in France. METHODS: All hospitalised patients from 2013 were identified from the French National database and included if they had at least 5 years of follow-up data. RESULTS: Overall, 3,381,472 patients were identified. After excluding 35,834 with a history of VAs and cardiac arrest, 3,345,638 patients were categorised into two groups: no AF (n = 3,033,412; mean age 57.2 ± 21.4; 54.3% female) and AF (n = 312,226; 78.1 ± 10.6; 44.0% female). Over a median follow-up period of 5.4 years (interquartile range (IQR) 5.0-5.8 years), the incidence (2.23%/year vs. 0.56%/year) and risk (hazard ratio (HR) 3.657 (95% confidence interval (CI) 3.604-3.711)) of VAs and cardiac arrest were significantly higher in AF patients compared to non-AF patients. This was still significant after adjusting for confounders, with a HR of 1.167 (95% CI 1.111-1.226) and in the 1:1 propensity score-matched analysis (n = 289,332 per group), with a HR of 1.339 (95% CI 1.313-1.366). In the mediation analysis, the odds of cardiac arrest were significantly mediated by AF-associated VAs, with an OR of 1.041 (95% CI 1.040-1.042). CONCLUSION: In hospitalised French patients, AF was associated with an increased risk of VAs and sudden death.

Cardiovascular outcomes in patients with cancer during a 5-year follow-up: Results from a French administrative database.

BACKGROUND: Limited data are available regarding the optimal management and prognosis of patients with cancer who develop an acute myocardial infarction. AIM: The objective of this study was to analyse the characteristics and outcomes of patients according to cancer and myocardial infarction occurrence. METHODS: Based on the French administrative hospital discharge database, the study collected information for all consecutive patients seen in French hospitals in 2013, excluding those with a history of myocardial infarction. The population was divided into two groups according to their history of cancer. We studied the following outcomes: all-cause and cardiovascular mortality; acute myocardial infarction; and ischaemic stroke. Data were collected after a 5-year follow-up. RESULTS: Between 2013 and 2019, 3,381,472 patients were seen in French hospitals; among them, 3,323,757 had no history of myocardial infarction. Patients with a history of cancer (n=497,593) had higher incidences of all-cause mortality (17.82%/year vs 3.79%/year), cardiovascular mortality (1.61%/year vs 1.17%/year), myocardial infarction (0.82%/year vs 0.61%/year) and ischaemic stroke (0.91%/year vs 0.62%/year) compared with patients without cancer (n=2,826,164). After performing an adjusted competing-risk analysis, the cumulative incidence of acute myocardial infarction, cardiovascular death and ischaemic stroke incidence was found to be lower in patients with a history of cancer, whereas death of non-cardiac origin was more prevalent in patients with a history of cancer. CONCLUSIONS: In this observational study, we have shown that patients with cancer have a higher incidence of all-cause mortality, cardiovascular mortality and myocardial infarction. However, multivariable analysis showed a lower cumulative incidence of these events.

Elderly Outcomes After Hospitalization: The Hospital Frailty Risk Score Applied on the French Health Data Hub.

Objectives: To demonstrate the association between the Hospital Frailty Risk Score (HFRS) and 30-day mortality, 30-day hospital readmission and length of stay (LOS) in France. Methods: Logistic regressions were performed using data recorded in the French national health data system (SNDS) for elderly patients (≥75 years old) hospitalized in France in 2017. Results: Over the 1,111,090 patients included, 30-day mortality was associated with the HFRS: adjusted OR (aOR) for an intermediate HFRS (5-15 points) was 1.91 [95% confidence interval (95% IC); 1.87-1.95] and aOR 2.57 [95% IC; 2.50-2.64] for high HFRS (>15 points), as compared to low HFRS (<5 points). LOS >10 days increased with the HFRS (aOR = 1.36 [95% IC; 1.34-1.38] for an intermediate HFRS and aOR 1.51 [95% IC; 1.48-1.54] for a high HFRS). A high HFRS was associated with 30-day hospital readmission (aOR = 1.06 [95% IC; 1.04-1.08]). Discussion: This real-life analysis of in- and out-patient healthcare pathways confirmed the HFRS's ability to predict adverse outcomes, after adjustment on social deprivation.

Adverse Cardiovascular Events in Non-Traumatic Intracranial Hemorrhage and Ischemic Stroke Survivors.

BACKGROUND: We aimed to evaluate different measures of adverse cardiovascular events between non-traumatic intracranial hemorrhage (ICrH) and ischemic stroke (IS) survivors with and without atrial fibrillation (AF). METHODS: Using a national hospitalization database we compared incidences and risks of all-cause in-hospital death, cardiovascular death, non-cardiovascular death, MACE-HF (in-hospital cardiovascular death, myocardial infarction, IS or new-onset heart failure [HF]) between ICrH and IS survivors with and without AF. Propensity-score matching was also performed. RESULTS: We identified 40,523 survivors of IS and 12,028 survivors of an ICrH without AF, and 20,449 IS survivors and 3574 ICrH survivors with AF. In unadjusted, adjusted and matched analyses, ICrH patients without AF had a higher risk of all-cause in-hospital death (Hazard Ratio (HR; for matched analyses) 1.80; 95% confidence interval (CI) 1.74-1.86), cardiovascular death (HR; 2.79; CI 2.64-2.94), MACE-HF (HR 1.97; CI 1.89-2.06) and new cerebrovascular events (HR 1.75; CI 1.57-1.96) but with lower risk of myocardial infarction (HR 0.81; CI 0.70-0.94), major bleeding (HR 0.92; CI 0.87-0.98) and new onset HF (HR 0.85; CI 0.79-0.91) compared to IS survivors without AF. Similar results were found for ICrH and IS survivors with AF except for myocardial infarction (HR 1.05; CI 0.79-1.34) and new onset HF (HR 0.94; CI 0.84-1.06) that were similar between the two groups. CONCLUSIONS: Adverse cardiovascular events are more frequent in ICrH survivors compared to IS survivors. New onset HF is a relatively frequent event after ICrH, especially in those patients with comorbid atrial fibrillation.

Performance of the HAS-BLED, ORBIT, and ATRIA Bleeding Risk Scores on a Cohort of 399 344 Hospitalized Patients With Atrial Fibrillation and Cancer: Data From the French National Hospital Discharge Database.

Background The association between cancer types and specific bleeding events in patients with atrial fibrillation has been scarcely investigated. Also, the performance of bleeding risk scores in this high-risk subgroup of patients is unclear. We investigated the rate of any bleeding, intracranial hemorrhage, major bleeding, and gastrointestinal bleeding according to cancer types in patients with atrial fibrillation. We also tested the predictive value of HAS-BLED, ATRIA, and ORBIT bleeding risk scores. Methods and Results Observational retrospective cohort study including hospitalized patients with atrial fibrillation and cancer from the French National Hospital Discharge Database (Programme de Medicalisation des Systemes d'Information) from January 2010 to December 2019. Major bleeding was defined according to Bleeding Academic Research Consortium definitions. Patients with HAS-BLED ≥3, ATRIA ≥5, or ORBIT ≥4 were classified as at high bleeding risk. Receiver operating characteristic analysis for each score against any bleeding, major bleeding, gastrointestinal bleeding, and intracranial hemorrhage was performed. Areas under the curve (AUCs) were then compared. We included 399 344 patients. Mean age was 77.9±10.2 years, and 63.2% were men. The highest intracranial hemorrhage rates were found in leukemia (1.89%/year), myeloma (1.52%/year), lymphoma and liver (1.45%/year), and pancreas cancer (1.41%/year). Receiver operating characteristic analysis showed that ORBIT score predicted best for any bleeding. In addition, ORBIT score ≥4 had the highest predictivity for major bleeding (AUC, 0.805), followed by HAS-BLED ≥3 and ATRIA ≥5 (AUCs, 0.716 and 0.700, respectively). HAS-BLED and ORBIT performed best for intracranial hemorrhage (AUCs, 0.744 and 0.742 for continuous scores, respectively), better than ATRIA (AUC, 0.635). For gastrointestinal bleeding, ORBIT ≥4 had the highest predictivity (AUC, 0.756), followed by the HAS-BLED ≥3 (AUC, 0.702) and ATRIA ≥5 (AUC, 0.662). Conclusions Some cancer types carry a greater bleeding risk in patients with atrial fibrillation. The identification and management of modifiable bleeding risk factors is crucial in these patients, as well as to flag up high bleeding risk patients for early review and follow-up.

Leadless or Conventional Transvenous Ventricular Permanent Pacemakers: A Nationwide Matched Control Study.

Background Leadless ventricular permanent pacemakers (leadless VVI or LPM) were designed to reduce lead-related complications of conventional VVI pacemakers (CPM). The aim of our study was to assess and compare real-life clinical outcomes within the first 30 days and during a midterm follow-up with the 2 techniques. Methods and Results This French longitudinal cohort study was based on the national hospitalization database. All adults (age ≥18 years) hospitalized in French hospitals from January 1, 2017 to September 1, 2020, who underwent a first LPM or CPM were included. The study included 40 828 patients with CPM and 1487 with LPM. After propensity score matching 1344 patients with CPM were matched 1:1 with patients treated with LPM. Patients with LPM had a lower rate of all-cause and cardiovascular death within the 30 days after implantation. During subsequent follow-up (mean: 8.6±10.5 months), risk of all-cause death in the unmatched population was significantly higher in the LPM group than in the CPM group, whereas risk of cardiovascular death and of endocarditis was not significantly different. After matching on all baseline characteristics including comorbidities (mean follow-up 6.2±8.7 months), all-cause death, cardiovascular death, and infective endocarditis were not statistically different in the 2 groups. Conclusions Patients treated with leadless VVI pacemakers had better clinical outcomes in the first month compared with the patients treated with conventional VVI pacing. During a midterm follow-up, risk of all-cause death, cardiovascular death, and endocarditis in patients treated with leadless VVI pacemaker was not statistically different after propensity score matching.

Mortality and Major Cardiovascular Events among Patients with Multiple Myeloma: Analysis from a Nationwide French Medical Information Database.

BACKGROUND: No robust data assesses the risk of all-cause death and cardiovascular (CV) events in multiple myeloma (MM) patients. PATIENTS AND METHODS: From 1 January to 31 December 2013, 3,381,472 adults were hospitalised (for any reason) in French hospitals. We identified 15,774 patients diagnosed with known MM at baseline. The outcome analysis (all-cause death, CV death, myocardial infarction (MI), ischaemic stroke, or hospitalization for bleedings) was performed with follow-ups starting at the time of the last event. For each MM patient, a propensity score-matched patient without MM was selected. RESULTS: The mean follow-up in the propensity-score-matched population was 3.7 ± 2.3 years. Matched patients with MM had a higher risk of all-death (yearly rate 20.02 vs. 11.39%) than patients without MM. No difference was observed between the MM group and no-MM group for CV death (yearly rate 2.00 vs. 2.02%). The incidence rate of MI and stroke was lower in the MM group: 0.86 vs. 0.97%/y and 0.85 vs. 1.10%/y, respectively. In contrast, MM patients had a higher incidence rate of rehospitalization for major bleeding (3.61 vs. 2.24%/y) and intracranial bleeding (1.03 vs. 0.84%/y). CONCLUSIONS: From a large nationwide database, we demonstrated that MM patients do not have a higher risk of CV death or even a lower risk of both MI and ischaemic stroke. Conversely, MM patients had a higher risk of both major and intracranial bleedings, highlighting the key issue of thromboprophylaxis in these patients.

Long-term impact of cardiorenal syndromes on major outcomes based on their chronology: a comprehensive French nationwide cohort study.

BACKGROUND: Cardiorenal syndromes (CRSs) are reputed to result in worse prognosis than isolated heart failure (HF) and chronic kidney disease (CKD). Whether it is true for all major outcomes over the long-term regardless of CRS chronology (simultaneous, cardiorenal and renocardiac CRS) is unknown. METHODS: The 5-year adjusted risk of major outcomes was assessed in this nationwide retrospective cohort study in all 385 687 with either CKD or HF (out of 5 123 193 patients who were admitted in a French hospital in 2012). RESULTS: Overall, 84.0% patients had HF and 8.9% had CKD (they had similar age, sex ratio, diabetes and hypertension prevalence), while 7.1% had CRS (cardiorenal: 44.6%, renocardiac: 14.5%, simultaneous CRS: 40.8%).The incidence of major outcomes was 57.3%, 53.0%, 79.2% for death; 18.8%, 10.9%, 27.5% for cardiovascular death; 52.6%, 34.7%, 64.3% for HF; 6.2%, 5.5%, 5.6% for myocardial infarction (MI); 6.1%, 5.8%, 5.3% for ischaemic stroke; and 23.1%, 4.8%, 16.1% for end-stage kidney disease (ESKD) for isolated CKD, isolated HF and CRS, respectively.As compared with isolated CKD or HF, the risk of death, cardiovascular death and HF was markedly increased in CRS, the worse phenotype being cardiorenal CRS, while the increased risk of MI and ischaemic stroke associated with CRS subtypes was statistically but not clinically significant. As compared with isolated CKD, the risk of ESKD was similar for cardiorenal CRS only and marginally increased for renocardiac and simultaneous CRS. We could not find a synergy between HF and CKD on major clinical outcomes in the whole population (n = 5 123 193 patients). CONCLUSIONS: The additional impact of CRS versus isolated HF or CKD on long-term kidney and cardiovascular risk is highly heterogenous, depending of the event considered and CRS chronology. No synergy between HF and CKD could be demonstrated.

Prognosis of Atrial Fibrillation with or without Comorbidities: Analysis of Younger Adults from a Nationwide Database.

Objective: To assess the prognosis of AF patients with or without cardiac or extra-cardiac concomitant conditions. Participants and Methods: All consecutive patients diagnosed with AF admitted to French hospitals between 2011 and 2020 were identified. Patients were classified into four groups: (1) > 60 yo; (2) with known cardiac disease (KCD group); (3) with extra-cardiac comorbidities (ECC); and 4) AF without KCD or ECC ("Lone AF"). Results: Altogether 2,435,541 patients were identified, from which 2,203,702 patients aged >60 years and 231,839 patients aged <60 years (with KCD (55.2%), with ECC (14.7%) and with "Lone AF" (30.1%)). During follow-up, the incidences of all-cause and CV deaths were 13.7%, 5.7%, 6.2%, and 2.3%, and 4.2%, 1.7%, 0.8%, and 0.3% in the older than 60 yo group, KCD group, ECC group and "Lone AF" AF group, respectively. In the age and sex-adjusted analysis (patients < 60 yo), patients with AF and KCD had worse outcomes than patients with "Lone AF" for all major cardiac events. Conclusion: There are three distinct prognostic criteria based on the presence or lack of HD or extra-cardiac concomitant comorbidities. Patients in the so-called "Lone AF" group remain severe in terms of CV events but still with a lower incidence than the patients with associated KCD or ECC. The presence of KCD or ECC makes it possible to distinguish a profile in terms of events that are very different between the patients.

Predicting outcome after cardiac resynchronisation therapy defibrillator implantation: the cardiac resynchronisation therapy defibrillator Futility score.

BACKGROUND: Risk-benefit for cardiac resynchronisation therapy (CRT) defibrillator (CRT-D) over CRT pacemaker remains a matter of debate. We aimed to identify patients with a poor outcome within 1 year of CRT-D implantation, and to develop a CRT-D Futility score. METHODS: Based on an administrative hospital-discharge database, all consecutive patients treated with prophylactic CRT-D implantation in France (2010-2019) were included. A prediction model was derived and validated for 1-year all-cause death after CRT-D implantation (considered as futility) by using split-sample validation. RESULTS: Among 23 029 patients (mean age 68±10 years; 4873 (21.2%) women), 7016 deaths were recorded (yearly incidence rate 7.2%), of which 1604 (22.8%) occurred within 1 year of CRT-D implantation. In the derivation cohort (n=11 514), the final logistic regression model included-as main predictors of futility-older age, diabetes, mitral regurgitation, aortic stenosis, history of hospitalisation with heart failure, history of pulmonary oedema, atrial fibrillation, renal disease, liver disease, undernutrition and anaemia. Area under the curve for the CRT-D Futility score was 0.716 (95% CI: 0.698 to 0.734) in the derivation cohort and 0.692 (0.673 to 0.710) in the validation cohort. The Hosmer-Lemeshow test had a p-value of 0.57 suggesting accurate calibration. The CRT-D Futility score outperformed the Goldenberg and EAARN scores for identifying futility. Based on the CRT-D Futility score, 15.9% of these patients were categorised at high risk (predicted futility of 16.6%). CONCLUSIONS: The CRT-D Futility score, established from a large nationwide cohort of patients treated with CRT-D, may be a relevant tool for optimising healthcare decision-making.

Comparison of Surgical Ventricular Septal Reduction to Alcohol Septal Ablation Therapy in Patients with Hypertrophic Cardiomyopathy.

Ventricular septal myectomy (SM) and alcohol septal ablation (ASA), 2 septal reduction therapies (SRTs), are recommended in symptomatic obstructive hypertrophic cardiomyopathy (HCM) despite maximum tolerated medical therapy. Contradictory results between the outcomes of these 2 types of therapies persist to this day. The objective of this study was to compare in-hospital and mid-term outcomes of SM versus ASA, at a nationwide level in France. We collected information on patients who underwent SRT for HCM using the French nationwide Programme de Médicalisation des Systèmes d'Information database between 2010 and 2019. A total of 1,574 patients were identified in the database, including 340 patients in the SM arm and 1,234 patients in the ASA arm. No difference during the median follow-up of 1.3 years between the 2 groups was noted in terms of mortality (adjusted incidence rate ratio 0.687, 95% confidence interval 0.361 to 1.309, p = 0.25). However, there was a significantly lower risk of all-cause stroke (adjusted incidence rate ratio 0.180, 95% confidence interval 0.058 to 0.554, p = 0.003) in the ASA group. In conclusion, in our "real-life" data from France, mortality after SRT in patients with HCM was similar after ASA or SM. Moreover, ASA was more widely used than SM despite European Society of Cardiology guidelines recommendations.

Yearly Incidence of Stroke and Bleeding in Atrial Fibrillation with Concomitant Hyperthyroidism: A National Discharge Database Study.

Background: Hyperthyroidism is associated with atrial fibrillation (AF), and the latter is a major risk factor for stroke. Aim: We aimed to investigate the yearly incidence of stroke and bleeding in AF patients with and without concomitant hyperthyroidism from the French National Hospital Discharge Database. Methods: Admissions with AF between January 2010 and December 2019 were retrospectively identified and retrieved from the French national database. Incidence rates of ischaemic stroke and bleeding were compared in AF patients with and without concomitant hyperthyroidism. The associations of risk factors with ischaemic stroke were assessed by Cox regression. Results: Overall 2,421,087 AF patients, among whom 32,400 had concomitant hyperthyroidism were included in the study. During the follow-up (mean: 2.0 years, standard deviation SD: 2.2 years), the yearly incidence of ischaemic stroke was noted to be 2.6 (95% confidence interval CI: 2.5−2.8) in AF patients with concomitant hyperthyroidism, and 2.3 (95%CI: 2.3−2.4) in non-thyroid AF patients. Hyperthyroidism was noted as an independent risk factor for ischaemic stroke (adjusted hazard ratio aHR: 1.133, 95%CI: 1.080−1.189) overall, particularly within the first year of hyperthyroidism diagnosis (aHR 1.203, 95%CI 1.120−1.291), however, the association became non-significant in subsequent years (aHR 1.047, 95%CI 0.980−1.118). Major bleeding incidence was lower in the hyperthyroid AF group in comparison to the non-thyroid AF group (incidence ratio: 5.1 vs. 5.4%/year, p < 0.001). The predictive value of CHA2DS2VASc and HAS-BLED scores for ischaemic stroke and bleeding events, respectively, did not differ significantly between AF patients with or without concomitant hyperthyroidism. Conclusions: Hyperthyroidism seems to be an independent risk factor of ischaemic stroke in AF patients, particularly within the first year of hyperthyroidism diagnosis.