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.

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.

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.

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.

Myocardial Revascularization Strategies in ST Elevation Myocardial Infarction Without Urgent Revascularization: Insight From a Nationwide Study.

OBJECTIVE: To analyze the outcomes of patients presenting with ST-segment elevation myocardial infarction (STEMI) without early (<48 hours) revascularization, according to percutaneous versus surgical revascularization. PATIENTS AND METHODS: Based on the French administrative hospital discharge database, the study collected information for all consecutive patients seen for a STEMI in France between January 1, 2010, to June 31, 2019, who underwent either a first percutaneous coronary intervention (PCI) or a first coronary artery bypass graft between 48 hours and 90 days after the index hospitalization. Propensity score matching was used for the analysis of outcomes. RESULTS: Of 71,365 patients with STEMI in the analysis, 59,340 patients underwent PCI and 12,025 patients underwent coronary artery bypass graft. In a matched analysis of 12,012 patients by arm, surgical revascularization was associated with lower rates of all cause (5.1% vs 7.1%; hazard ratio [HR], 0.70; 95% CI, 0.66 to 0.75) and cardiovascular (2.6% vs 3.1%; HR, 0.83; 95% CI, 0.76 to 0.91) death. Rehospitalization for heart failure was less often reported after surgery (5.5% vs 7.5%; HR, 0.76; 95% CI, 0.71 to 0.81) whereas stroke incidence was not statistically different between the two arms (2.1% vs 2.3%; HR, 0.90; 95% CI, 0.80 to 1.00). Major bleeding was less often reported in the PCI arm (4.6% vs 6.1%; HR, 1.31; 95% CI, 1.22 to 1.41). CONCLUSION: In patients with STEMI who did not undergo urgent revascularization (ie, within 48 hours after presentation), surgical revascularization was associated with better outcomes and should be individually considered as an alternative to PCI.

Breast cancer and incident cardiovascular events: A systematic analysis at the nationwide level.

BACKGROUND: Breast cancer (BC) is one of the most common cancers worldwide, and the treatments are frequently cardiotoxic. Whether BC is associated with a higher risk of cardiovascular events is a matter of debate. We evaluated the associations among BC and incident cardiovascular events in a contemporary population. METHODS: All female patients discharged from French hospitals in 2013 with at least 5 years of follow-up and without a history of major adverse cardiovascular event (myocardial infarction [MI], heart failure [HF], ischaemic stroke or all-cause death, and MACE-HF, which includes cardiovascular death, MI, ischaemic stroke or HF) or cancer (except BC) were identified. After propensity score matching, patients with BC were matched 1:1 with patients with no BC. Hazard ratios (HRs) for cardiovascular events during follow-up were adjusted on age, sex and smoking status at baseline. RESULTS: 1,795,759 patients were included, among whom 64,480 (4.3%) had history of BC. During a mean follow-up of 5.1 years, matched female patients with BC had a higher risk of all-cause death (HR 3.55, 95% confidence interval [CI]: 3.47-3.64), new-onset HF (HR 1.08, 95% CI 1.04-1.11), major bleeding (HR 1.43, 95% CI 1.36-1.49), MACE-HF (HR 1.07, 95% CI 1.04-1.11) and net adverse clinical events (NACE) including all-cause death, MI, ischaemic stroke, HF or major bleeding (HR 2.53, 95% CI 2.48-2.58) compared with those with no BC. By contrast, risks were not higher for cardiovascular death (HR 0.94, 95% CI 0.88-1.00) and were lower for MI (HR 0.81, 95% CI 0.75-0.88) and ischaemic stroke (HR 0.85, 95% CI 0.79-1.11). CONCLUSIONS: In a large and contemporary analysis of female patients seen in French hospitals, women with history of breast cancer had a higher risk of all-cause mortality, new-onset heart failure and major bleeding compared to a matched cohort of women without breast cancer. In contrast, they have a reduced risk of cardiovascular mortality, MI and stroke.

Ischemic Stroke in Patients With Hypertrophic Cardiomyopathy According to Presence or Absence of Atrial Fibrillation.

BACKGROUND AND PURPOSE: Patients with hypertrophic cardiomyopathy (HCM) have high risk of ischemic stroke (IS), especially if atrial fibrillation (AF) is present. Improvements in risk stratification are needed to help identify those patients with HCM at higher risk of stroke, whether AF is present or not. METHODS: This French longitudinal cohort study from the database covering hospital care from 2010 to 2019 analyzed adults hospitalized with isolated HCM. A logistic regression model was used to construct a French HCM score, which was compared with the HCM Risk-CVA and CHA2DS2-VASc scores using c-indexes and calibration analysis. RESULTS: In 32 206 patients with isolated HCM, 12 498 (38.8%) had AF, and 2489 (7.7%) sustained an IS during follow-up. AF in patients with HCM was independently associated with a higher risk for death (hazard ratio, 1.129 [95% CI, 1.088-1.172]), cardiovascular death (hazard ratio, 1.254 [95% CI, 1.177-1.337]), IS (hazard ratio, 1.210 [95% CI, 1.111-1.317]), and other major cardiovascular events. Independent predictors of IS in HCM were older age, heart failure, AF, prior IS, smoking and poor nutrition (all P<0.05). For the HCM Risk-CVA score, CHA2DS2-VASc score and a French HCM score, all c-indexes were 0.65 to 0.70, with good calibration. Among patients with AF, the CHA2DS2-VASc score had marginal improvement over the HCM Risk-CVA score but was less predictive compared with the French HCM score (P=0.001). In patients without AF, both HCM Risk-CVA score and the French HCM score had significantly better prediction compared with CHA2DS2-VASc (both P<0.0001). Decision curve analysis demonstrated that the French HCM score had the best clinical usefulness of the 3 tested risk scores. CONCLUSIONS: Patients with HCM have a high prevalence of AF and a significant risk of IS, and the presence of AF in patients with HCM was independently associated with worse outcomes. A simple French HCM score shows good prediction of IS in patients with HCM and clinical usefulness, with good calibration.

Major Bleeding of Transjugular Native Kidney Biopsies. A French Nationwide Cohort Study.

INTRODUCTION: The risk of bleeding associated with transjugular kidney biopsies is unclear, and which patients are the best candidates for this route is unknown. METHODS: This was a retrospective cohort study comparing proportion of bleeding associated with transjugular versus percutaneous native kidney biopsies in all patients in France in the 2010-2019 period. Major bleeding at day 8 (i.e., blood transfusions, hemorrhage/hematoma, angiographic intervention, nephrectomy) and risk of death at day 30 were assessed, and we used a bleeding risk score initially developed for the percutaneous route. RESULTS: Our analysis included 60,331 patients (transjugular route: 5305; percutaneous route: 55,026 patients). The observed proportion of major bleeding varied widely (transjugular vs. percutaneous): 0.4% versus 0.5% for the lowest risk scores (0-4) to 19.1% versus 30.8% for the highest risk scores (≥35). Transjugular was more frequently used than percutaneous route (39% vs. 24%) when the risk score was ≥20 (15,133/60,331; 25% of all patients). Transjugular was associated with a lower risk of major bleeding than percutaneous route in multivariate analyses (odds ratio [OR]: 0.88 [0.78-0.99]), especially for scores ≥20 (OR: 0.83 [0.72-0.96], (i.e., 25% of patients). Major bleeding was associated with an increased risk of death both for transjugular (OR: 1.77 [1.00-3.14]) and percutaneous (OR: 1.80 [1.43-2.28]) routes. CONCLUSIONS: The transjugular route is independently associated with a lower risk of bleeding than the percutaneous route, especially in high-risk patients identified by a preprocedure risk score ≥20 (i.e., 25% of patients). Major bleeding is associated with an increased risk of death for both routes.

Outcomes in patients with acute myocardial infarction and history of illicit drug use: a French nationwide analysis.

AIMS: Several reports suggest that illicit drug use may be a major cause of acute myocardial infarction (AMI) independently of smoking habits and associated with a poorer prognosis. The aim of our study was to evaluate the impact of illicit drug use on (i) the risk of AMI and (ii) its prognosis. METHODS AND RESULTS: This French longitudinal cohort study was based on the administrative hospital-discharge database from the entire population. First, we collected data for all patients admitted in hospital in 2013 with at least 5 years of follow-up to identify potential predictors of AMI. In a second phase, we collected data for all patients admitted with AMI from January 2010 to December 2018. We identified patients with a history of illicit drug use (cannabis, cocaine, or opioid). These patients were matched with patients without illicit drug use to assess their prognosis. In 2013, 3 381 472 patients were hospitalized with a mean follow-up of 4.7 ± 1.8 years. In multivariable analysis, among all drugs under evaluation, only cannabis use was significantly associated with a higher risk of AMI [HR 1.32 (95% CI 1.09-1.59), P = 0.004]. Between January 2010 and December 2018, we then identified 738 899 AMI patients. Among these patients, 3827 (0.5%) had a known history of illicit drug use. These patients were younger, most often male and had less comorbidities. After 1:1 propensity score matching, during a mean follow-up of 1.9 ± 2.3 years, there was no significant difference between patients without illicit drug use and patients with illicit drug use regarding all-cause death, cardiovascular death, stroke, or heart failure. CONCLUSION: In a large and systematic nationwide analysis, cannabis use was an independent risk factor for the incidence of AMI. However, the prognosis of illicit drug users presenting with AMI was similar to patients without illicit drug use.

Metabolically healthy obesity and cardiovascular events: A nationwide cohort study.

AIM: To evaluate the associations between metabolically healthy obesity (MHO) and different types of incident cardiovascular events in a contemporary population. MATERIALS AND METHODS: All patients discharged from French hospitals in 2013 with at least 5 years of follow-up and without a history of major adverse cardiovascular event (MACE; myocardial infarction, heart failure [HF], ischaemic stroke or cardiovascular death [MACE-HF]) or underweight/malnutrition were identified. They were categorized by phenotypes defined by obesity and three metabolic abnormalities (diabetes, hypertension and hyperlipidaemia). Hazard ratios (HRs) for cardiovascular events during follow-up were adjusted on age, sex and smoking status at baseline. RESULTS: In total, 2 873 039 individuals were included in the analysis, among whom 272 838 (9.5%) had obesity. During a mean follow-up of 4.9 years, when pooling men and women, individuals with MHO had a higher risk of MACE-HF (multivariate-adjusted HR 1.22, 95% confidence interval [CI]: 1.19-1.24), new-onset HF (HR 1.34, 95% CI 1.31-1.37) and atrial fibrillation (AF; HR 1.33, 95% CI 1.30-1.37) compared with individuals with no obesity and zero metabolic abnormalities. By contrast, risks were not higher for myocardial infarction (HR 0.92, 95% CI 0.87-0.98), ischaemic stroke (HR 0.93, 95% CI 0.88-0.98) and cardiovascular death (HR 0.99, 95% CI 0.93-1.04). MHO in men was associated with a higher risk of clinical events compared with metabolically healthy men of normal weight (HR 1.12-1.80), while women with MHO had a lower risk for most events than metabolically healthy women of normal weight (HR 0.49-0.99). CONCLUSIONS: In a large and contemporary analysis of patients seen in French hospitals, individuals with MHO did not have a higher risk of myocardial infarction, ischaemic stroke or cardiovascular death than metabolically healthy individuals with no obesity. By contrast, they had a higher risk of new-onset HF and new-onset AF. However, notable differences were observed in men and women in the sex-stratified analysis.

Role of real-world digital data for orthopedic implant automated surveillance: a systematic review.

INTRODUCTION: Data collection automation through the reuse of real-world digital data from clinical data warehouses (CDW) could represent a great opportunity to improve medical device monitoring. For instance, this approach is starting to be used for the design of automated decision support systems for joint replacement monitoring. However, a number of obstacles remains, such as data quality and interoperability through the use of common and regularly updated terminologies, and the use of a Unique Device Identifier (UDI). AREAS COVERED: To present the existing models of automated surveillance of orthopedic devices, a systematic review of initiatives using real-world digital health data to monitor joint replacement surgery was performed following the PRISMA 2020 guidelines. The main objective was to identify the data sources, the target populations, the population size, the device location, and the main results of studies on such initiatives. EXPERT OPINION: Analysis of the identified studies showed that real-world digital data offer many opportunities for improving the automation of monitoring in orthopedics. The contribution of real-world data, especially through natural language processing, UDI use in CDW and the integration of device databases, is needed for automated and more robust health surveillance.

Thromboembolism, mortality, and bleeding in 2,435,541 atrial fibrillation patients with and without cancer: A nationwide cohort study.

BACKGROUND: The number of patients with atrial fibrillation (AF) and cancer is rapidly increasing in clinical practice. The impact of cancer on clinical outcomes in this patient population is unclear, as is the performance of the HAS-BLED (Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol) and CHA2 DS2 -VASc (Congestive Heart Failure, Hypertension, Age ≥ 75 years, Diabetes Mellitus, Stroke or Transient Ischemic Attack, Vascular Disease, Age 65 to 74 Years, Sex Category) scores. METHODS: This was an observational, retrospective cohort study including 2,435,541 adults hospitalized with AF. The authors investigated the incidence rates (IRs) of all-cause and cardiovascular mortality, ischemic stroke, major bleeding, and intracranial hemorrhage (ICH) according to the presence of cancer and cancer types. RESULTS: Overall, 399,344 (16.4%) had cancer, with the most common cancers being metastatic, prostatic, colorectal, lung, breast, and bladder. During a mean follow-up of 2.0 years, cancer increased all-cause mortality (hazard ratio [HR], 2.00; 95% confidence interval [CI], 1.99-2.01). The IR of ischemic stroke was higher with pancreatic cancer (2.8%/y), uterine cancer (2.6%/y), and breast cancer (2.6%/y), whereas it was lower with liver/lung cancer (1.9%/y) and leukemia/myeloma (2.0%/y), in comparison with noncancer patients (2.4%/y). Cancer increased the risk of major bleeding (HR, 1.27; 95% CI, 1.26-1.28) and ICH (HR, 1.07; 95% CI, 1.05-1.10). Leukemia, liver cancer, myeloma, and metastatic cancers showed the highest IRs for major bleeding/ICH. Major bleeding and ICH rates progressively increased with the HAS-BLED score, which showed generally good predictivity with C indexes > 0.70 for all cancer types. The CHA2 DS2 -VASc score's predictivity was slightly lower in AF patients with cancer. CONCLUSIONS: Cancer increased all-cause mortality, major bleeding, and ICH risk in AF patients. The association between cancer and ischemic stroke differed among cancer types, and in some types, the risk of bleeding seemed to exceed the thromboembolic risk.

Valve-in-valve transcatheter aortic valve implantation after failed surgically implanted aortic bioprosthesis versus native transcatheter aortic valve implantation for aortic stenosis: Data from a nationwide analysis.

BACKGROUND: Valve-in-valve transcatheter aortic valve implantation (TAVI) has emerged as a treatment for aortic bioprosthesis failure in case of prohibitive risk for redo surgery. However, clinical evaluation of valve-in-valve TAVI remains limited by the number of patients analysed. AIM: To evaluate outcomes of valve-in-valve TAVI compared with native aortic valve TAVI at a nationwide level in France. METHODS: Based on the French administrative hospital discharge database, the study collected information for all consecutive patients treated with TAVI for aortic stenosis or with isolated valve-in-valve TAVI for aortic bioprosthesis failure between 2010 and 2019. Propensity score matching was used for the analysis of outcomes. RESULTS: A total of 44,218 patients were found in the database. After matching on baseline characteristics, 2749 patients were analysed in each arm. At 30 days, no significant differences were observed regarding the occurrence of major clinical events (composite of cardiovascular mortality, all-cause stroke, myocardial infarction, major or life-threatening bleeding and conversion to open heart surgery) (odds ratio [OR] 0.83, 95% confidence interval [CI] 0.68-1.01; P=0.32). During follow-up (mean 516 days), the combined endpoint of cardiovascular death, all-cause stroke or rehospitalization for heart failure was not different between the valve-in-valve TAVI and native TAVI groups (RR 1.03, 95% CI 0.94-1.13; P=1.00). CONCLUSION: We observed that valve-in-valve TAVI was associated with good short- and long-term outcomes. No significant differences were observed compared with native valve TAVI regarding clinical follow-up.

Major Bleeding and Risk of Death after Percutaneous Native Kidney Biopsies: A French Nationwide Cohort Study.

BACKGROUND AND OBJECTIVES: The risk of major bleeding after percutaneous native kidney biopsy is usually considered low but remains poorly predictable. The aim of the study was to assess the risk of major bleeding and to build a preprocedure bleeding risk score. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Our study was a retrospective cohort study in all 52,138 patients who had a percutaneous native kidney biopsy in France in the 2010-2018 period. Measurements included major bleeding (i.e., blood transfusions, hemorrhage/hematoma, angiographic intervention, or nephrectomy) at day 8 after biopsy and risk of death at day 30. Exposures and outcomes were defined by diagnosis codes. RESULTS: Major bleeding occurred in 2765 of 52,138 (5%) patients (blood transfusions: 5%; angiographic intervention: 0.4%; and nephrectomy: 0.1%). Nineteen diagnoses were associated with major bleeding. A bleeding risk score was calculated (Charlson index [2-4: +1; 5 and 6: +2; >6: +3]; frailty index [1.5-4.4: +1; 4.5-9.5: +2; >9.5: +3]; women: +1; dyslipidemia: -1; obesity: -1; anemia: +8; thrombocytopenia: +2; cancer: +2; abnormal kidney function: +4; glomerular disease: -1; vascular kidney disease: -1; diabetic kidney disease: -1; autoimmune disease: +2; vasculitis: +5; hematologic disease: +2; thrombotic microangiopathy: +4; amyloidosis: -2; other kidney diagnosis: -1) + a constant of 5. The risk of bleeding went from 0.4% (lowest score group =0-4 points) to 33% (highest score group ≥35 points). Major bleeding was an independent risk of death (500 of 52,138 deaths: bleeding: 81 of 2765 [3%]; no bleeding: 419 of 49,373 [0.9%]; odds ratio, 1.95; 95% confidence interval, 1.50 to 2.54; P<0.001). CONCLUSIONS: The risk of major bleeding after percutaneous native kidney biopsy may be higher than generally thought and is associated with a twofold higher risk of death. It varies widely but can be estimated with a score useful for shared decision making and procedure choice.

Transcatheter Valve-in-Valve Aortic Valve Replacement as an Alternative to Surgical Re-Replacement.

BACKGROUND: Valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR) and redo surgical aortic valve replacement (SAVR) represent the 2 treatments for aortic bioprosthesis failure. Clinical comparison of both therapies remains limited by the number of patients analyzed. OBJECTIVES: The purpose of this study was to analyze the outcomes of VIV TAVR versus redo SAVR at a nationwide level in France. METHODS: Based on the French administrative hospital-discharge database, the study collected information for patients treated for aortic bioprosthesis failure with isolated VIV TAVR or redo SAVR between 2010 and 2019. Propensity score matching was used for the analysis of outcomes. RESULTS: A total of 4,327 patients were found in the database. After matching on baseline characteristics, 717 patients were analyzed in each arm. At 30 days, VIV TAVR was associated with lower rates of the composite of all-cause mortality, all-cause stroke, myocardial infarction, and major or life-threatening bleeding (odds ratio: 0.62; 95% confidence interval: 0.44 to 0.88; p = 0.03). During follow-up (median 516 days), the combined endpoint of cardiovascular death, all-cause stroke, myocardial infarction, or rehospitalization for heart failure was not different between the 2 groups (odds ratio: 1.18; 95% confidence interval: 0.99 to 1.41; p = 0.26). Rehospitalization for heart failure and pacemaker implantation were more frequently reported in the VIV TAVR group. A time-dependent interaction between all-cause and cardiovascular mortality following VIV TAVR was reported (p-interaction <0.05). CONCLUSIONS: VIV TAVR was observed to be associated with better short-term outcomes than redo SAVR. Major cardiovascular outcomes were not different between the 2 treatments during long-term follow-up.

Futility Risk Model for Predicting Outcome After Transcatheter Aortic Valve Implantation.

Risk-benefit assessment for transcatheter aortic valve implantation (TAVI) is still a matter of debate. We aimed to identify patients with a bad outcome within 1 year after TAVI, and to develop a Futile TAVI Simple score (FTS). Based on the administrative hospital-discharge database, all consecutive patients treated with percutaneous TAVI in France between 2010 and 2018 were included. A prediction model was derived and validated for 1-year all-cause death after TAVI (considered as futility) by using split-sample validation: 20,443 patients were included in the analysis (mean age 83 ± 7 years). 7,039 deaths were recorded (yearly incidence rate 15.5%), among which 3,702 (53%) occurred in first year after TAVI procedure. In the derivation cohort (n = 10,221), the final logistic regression model included male sex, history of hospital stay with heart failure, history of pulmonary oedema, atrial fibrillation, previous stroke, vascular disease, renal disease, liver disease, pulmonary disease, anaemia, history of cancer, metastasis, depression and denutrition. The area under the curve (AUC) for the FTS was 0.674 (95%CI 0.660 to 0.687) in the derivation cohort and 0.651 (95%CI 0.637 to 0.665) in the validation cohort (n = 10,222). The Hosmer-Lemeshow test had a p-value of 0.87 suggesting an accurate calibration. The FTS score outperformed EuroSCORE II, Charlson comorbidity index and frailty index for identifying futility. Based on FTS score, 7% of these patients were categorized at high risk with a 1-year mortality at 43%. In conclusion, the FTS score, established from a large nationwide cohort of patients treated with TAVI, may provide a relevant tool for optimizing healthcare decision.