Prognostic impact of precipitated cardiac decompensation in symptomatic heart failure with reduced ejection fraction and severe secondary mitral regurgitation.

BACKGROUND: Our aim was to assess the distribution of primary (with no trigger) and secondary (with a decompensation trigger) heart failure events in a severe heart failure population and their association with 2-year all-cause mortality in the Mitra.Fr study. METHODS: We included 304 patients with symptomatic heart failure, and severe mitral regurgitation and guideline directed medical therapy randomized to medical therapy alone or medical therapy with percutaneous mitral valve repair. According to the follow-up, we defined 3 categories of events: follow-up without any heart failure event, at least 1 decompensation starting with a primary heart failure decompensation or starting with a precipitated secondary heart failure event. The primary outcome was 2-years all-cause mortality. RESULTS: A total of 179 patients (59 %) had at least 1 heart failure decompensation within 24-months of follow-up. 129 heart failure decompensations (72%) were a first primary heart failure and 50 (28%) were a first secondary decompensation. Finally, 30 patients had both types of decompensations but these were not taken into account for the comparison of primary and secondary decompensations. Primary decompensations were 3-times more frequent than secondary decompensations, but the mean number of heart failure decompensations was similar in the "Primary heart failure group" compared to the "Secondary heart failure group": (1.94 ± 1.39 vs 1.80 ± 1.07 respectively; P = .480). Compared to patients without heart failure decompensation, patients with "Only primary decompensation" or with "Only secondary decompensation" had a significantly increased risk of death (HR = 4.87, 95% CI [2.86, 8.32] and 2.68 95%CI [1.64, 4.37] respectively). All-cause mortality, was not significantly different between these 2 type of decompensations (HR = 1.82, 95% CI [0.93, 3.58]; P = .082), but each additional heart failure recurrence was associated with a significant increase in mortality risk (HR = 1.27, 95% CI [1.08; 1.50]; P = .005). CONCLUSIONS: In heart failure with reduced ejection fraction and severe secondary mitral regurgitation patients, primary heart failure decompensations were 3-times more frequent compared to precipitated decompensations with a nonsignificant trend in increased risk of all-cause mortality. Our results fail to support the differentiation between primary and secondary decompensations as they seem to portend the same outcome impact.

Coronary CT Angiography with Photon-counting CT: First-In-Human Results.

Background Spatial resolution, soft-tissue contrast, and dose-efficient capabilities of photon-counting CT (PCCT) potentially allow a better quality and diagnostic confidence of coronary CT angiography (CCTA) in comparison to conventional CT. Purpose To compare the quality of CCTA scans obtained with a clinical prototype PCCT system and an energy-integrating detector (EID) dual-layer CT (DLCT) system. Materials and Methods In this prospective board-approved study with informed consent, participants with coronary artery disease underwent retrospective electrocardiographically gated CCTA with both systems after injection of 65-75 mL of 400 mg/mL iodinated contrast agent at 5 mL/sec. A prior phantom task-based quality assessment of the detectability index of coronary lesions was performed. Ultra-high-resolution parameters were used for PCCT (1024 matrix, 0.25-mm section thickness) and EID DLCT (512 matrix, 0.67-mm section thickness). Three cardiac radiologists independently performed a blinded analysis using a five-point quality score (1 = insufficient, 5 = excellent) for overall image quality, diagnostic confidence, and diagnostic quality of calcifications, stents, and noncalcified plaques. A logistic regression model, adjusted for radiologists, was used to evaluate the proportion of improvement in scores with the best method. Results Fourteen consecutive participants (12 men; mean age, 61 years ± 17) were enrolled. Scores of overall quality and diagnostic confidence were higher with PCCT images with a median of 5 (interquartile range [IQR], 2) and 5 (IQR, 1) versus 4 (IQR, 1) and 4 (IQR, 3) with EID DLCT images, using a mean tube current of 255 mAs ± 0 versus 349 mAs ± 111 for EID DLCT images (P < .01). Proportions of improvement with PCCT images for quality of calcification, stent, and noncalcified plaque were 100%, 92% (95% CI: 71, 98), and 45% (95% CI: 28, 63), respectively. In the phantom study, detectability indexes were 2.3-fold higher for lumen and 2.9-fold higher for noncalcified plaques with PCCT images. Conclusion Coronary CT angiography with a photon-counting CT system demonstrated in humans an improved image quality and diagnostic confidence compared with an energy-integrating dual-layer CT. © RSNA, 2022 Online supplemental material is available for this article. See also the editorial by Sandfort and Bluemke in this issue.

Combined model-based and deep learning-based automated 3D zonal segmentation of the prostate on T2-weighted MR images: clinical evaluation.

OBJECTIVE: To train and to test for prostate zonal segmentation an existing algorithm already trained for whole-gland segmentation. METHODS: The algorithm, combining model-based and deep learning-based approaches, was trained for zonal segmentation using the NCI-ISBI-2013 dataset and 70 T2-weighted datasets acquired at an academic centre. Test datasets were randomly selected among examinations performed at this centre on one of two scanners (General Electric, 1.5 T; Philips, 3 T) not used for training. Automated segmentations were corrected by two independent radiologists. When segmentation was initiated outside the prostate, images were cropped and segmentation repeated. Factors influencing the algorithm's mean Dice similarity coefficient (DSC) and its precision were assessed using beta regression. RESULTS: Eighty-two test datasets were selected; one was excluded. In 13/81 datasets, segmentation started outside the prostate, but zonal segmentation was possible after image cropping. Depending on the radiologist chosen as reference, algorithm's median DSCs were 96.4/97.4%, 91.8/93.0% and 79.9/89.6% for whole-gland, central gland and anterior fibromuscular stroma (AFMS) segmentations, respectively. DSCs comparing radiologists' delineations were 95.8%, 93.6% and 81.7%, respectively. For all segmentation tasks, the scanner used for imaging significantly influenced the mean DSC and its precision, and the mean DSC was significantly lower in cases with initial segmentation outside the prostate. For central gland segmentation, the mean DSC was also significantly lower in larger prostates. The radiologist chosen as reference had no significant impact, except for AFMS segmentation. CONCLUSIONS: The algorithm performance fell within the range of inter-reader variability but remained significantly impacted by the scanner used for imaging. KEY POINTS: • Median Dice similarity coefficients obtained by the algorithm fell within human inter-reader variability for the three segmentation tasks (whole gland, central gland, anterior fibromuscular stroma). • The scanner used for imaging significantly impacted the performance of the automated segmentation for the three segmentation tasks. • The performance of the automated segmentation of the anterior fibromuscular stroma was highly variable across patients and showed also high variability across the two radiologists.

Hypobaric Unilateral Spinal Anesthesia Versus General Anesthesia for Hip Fracture Surgery in the Elderly: A Randomized Controlled Trial.

BACKGROUND: Hypotension during surgery is frequent in the elderly population and is associated with acute kidney and myocardial injury, which are, themselves, associated with increased 30-day mortality. The present study compared the hemodynamic effects of hypobaric unilateral spinal anesthesia (HUSA) to general anesthesia (GA) in patients ≥70 years of age undergoing hip fracture surgery. METHODS: We conducted a single-center, prospective, randomized study. In the HUSA group, patients were positioned with the operated hip above, and the hypobaric anesthetic solution was composed of 9 mg ropivacaine, 5 µg sufentanil, and 1 mL of sterile water. Anesthesia was adjusted for the GA group. Mean arterial pressure (MAP) was measured with a noninvasive blood pressure upper arm cuff every 3 minutes. Hypotension was treated with a bolus of ephedrine and then a continuous intravenous of norepinephrine to obtain a MAP ≥65 mm Hg. Primary outcome was the occurrence of severe hypotension, defined as a MAP <65 mm Hg for >12 consecutive minutes. RESULTS: A total of 154 patients were included. Severe hypotension was more frequent in the GA group compared to the HUSA group (odds ratio, 5.6; 95% confidence interval, 2.7-11.7; P < .001). There was no significant difference regarding the short-term outcomes between the HUSA and GA groups: acute kidney injury (respectively, 5.1% vs 11.3%; P = .22), myocardial injury (18.0% vs 14.0%; P = .63), and 30-day mortality (2.4% vs 4.7%; P = .65). CONCLUSIONS: HUSA leads to fewer episodes of severe intraoperative hypotension compared to GA in an elderly population undergoing hip fracture surgery.

Development and Survival of Human Ovarian Cells in Chitosan Hydrogel Micro-Bioreactor.

Background and Objectives: To test the long-term ability of human ovarian cortex cells to develop in unconventional culture conditions. Materials and Methods. Ovarian cortex cells from fetuses aged 23 to 39 weeks gestation were cultured for 90 days in hollow chitosan hydrogel micro-bioreactors and concurrently in traditional wells. Various cell-type counts were considered. Results: With intact follicles as a denominator, the percentage of growing intact follicles at Day 0 varied widely between ovaries (0 to 31.7%). This percentage tended to increase or stay relatively constant in bioreactor as in control cultures; it tended more toward an increase over time in bioreactor vs. control cultures. Modeled percentages showed differences (though not significant) in favor of bioreactor cultures (16.12% difference at D50 but only 0.12% difference at D90). With all follicles present as a denominator, the percentage of growing primary and secondary follicles at D0 varied widely between ovaries (0 to 29.3%). This percentage tended to increase over time in bioreactor cultures but to decrease in control cultures. Modeled percentages showed significant differences in favor of bioreactor cultures (8.9% difference at D50 and 11.1% difference at D90). At D50 and D90, there were only few and sparse apoptotic cells in bioreactor cultures vs. no apoptotic cells in control cultures. Conclusions: Over three months, bioreactor folliculogenesis outperformed slightly traditional culture. This is an interesting perspective for follicle preservation and long-term toxicological studies.

Interleukin 17 acts in synergy with B cell-activating factor to influence B cell biology and the pathophysiology of systemic lupus erythematosus.

Studies have suggested involvement of interleukin 17 (IL-17) in autoimmune diseases, although its effect on B cell biology has not been clearly established. Here we demonstrate that IL-17 alone or in combination with B cell-activating factor controlled the survival and proliferation of human B cells and their differentiation into immunoglobulin-secreting cells. This effect was mediated mainly through the nuclear factor-kappaB-regulated transcription factor Twist-1. In support of the relevance of our observations and the potential involvement of IL-17 in B cell biology, we found that the serum of patients with systemic lupus erythematosus had higher concentrations of IL-17 than did the serum of healthy people and that IL-17 abundance correlated with the disease severity of systemic lupus erythematosus.

A beat-by-beat cardiovascular index, CARDEAN, to titrate opioid administration in the setting of orthopaedic surgery: a prospective randomized trial.

To determine whether a beat-by-beat cardiovascular index (CARDEAN: cardiovascular depth of analgesia, Alpha-2 Ltd, Lyon, France) reduces the incidence of tachycardia in ASA I-III patients undergoing orthopaedic surgery. A total of 76 patients were prospectively randomized into (1) a control group or (2) the CARDEAN group, in which the nurse anaesthetist was blinded to CARDEAN application. In addition to conventional signs, an external observer instructed the nurse anaesthetist to administer sufentanil 0.1 µg kg-1 when the CARDEAN crossed a threshold (≥ 60). The primary outcome was the incidence of tachycardia (> 120% of reference heart rate, HR). Non-invasive blood pressure (BP), electrocardiogram (ECG), O2 saturation-photoplethysmography and the bispectral index (40 < BIS < 60) were monitored. HR and an estimation of beat-by-beat BP changes acquired from photoplethysmography and ECG were combined in an algorithm that detected hypertension followed by tachycardia (index scaled 0-100). Sufentanil 0.1 µg kg-1 was administered when tachycardia, hypertension or movement ("conventional signs") was observed. Data for 66 patients (27 with known hypertension) were analysed. In the CARDEAN group, (a) the dose of sufentanil was higher (control: 0.46 µg kg-1 100 min-1, CARDEAN: 0.57 µg kg-1 100 min-1, p = 0.016), (b) the incidence rates of tachycardia and untoward events were lower (respectively: - 44%; control: 2.52 events 100 min-1 [1.98-3.22]; CARDEAN: 1.42 [1.03-1.96], p = 0.005, hazard ratio: 0.56; movement, muscular contraction, or coughing: control: 0.74 events 100 min-1 [0.47-1.16]; CARDEAN: 0.31 [0.15-0.62], p = 0.038), and (c) extubation occurred more often in the operating room (control: 76.5%, CARDEAN: 97%, p = 0.016). CARDEAN-titrated opioid administration was associated with a higher dose of sufentanil, a reduction in tachycardia and earlier emergence in ASA I-III patients undergoing major orthopaedic surgery.

Combined interventions to reduce HIV incidence in KwaZulu-Natal: a modelling study.

BACKGROUND: Combined prevention interventions, including early antiretroviral therapy initiation, may substantially reduce HIV incidence in hyperendemic settings. Our aim was to assess the potential short-term impact of combined interventions on HIV spreading in the adult population of Mbongolwane and Eshowe (KwaZulu-Natal, South Africa) using sex- and age-specific scenarios, and age-targeted interventions. METHODS: A mathematical model was used with data on adults (15-59 years) from the Mbongolwane and Eshowe HIV Impact in Population Survey to compare the effects of various interventions on the HIV incidence rate. These interventions included increase in antiretroviral therapy (ART) coverage with extended eligibility criteria, increase in voluntary medical male circumcision (VMMC), and implementation of pre-exposure prophylaxis (PrEP) among women. RESULTS: With no additional interventions to the ones in place at the time of the survey (ART at CD4 < 350 and VMMC), incidence will decrease by 24% compared to the baseline rate. The implementation of "ART at CD4<500" or "ART for all" would reduce further the incidence rate by additional 8% and 15% respectively by 4 years and 20% and 34% by 10 years. Impacts would be higher with age-targeted scenarios than without. CONCLUSIONS: In Mbongolwane and Eshowe, implementation of the new South African guidelines, recommending ART initiation regardless of CD4 count, would accelerate incidence reduction. In this setting, combining these guidelines, VMMC, and PrEP among young women could be an effective strategy in reducing the incidence to low levels.

Potential impact of multiple interventions on HIV incidence in a hyperendemic region in Western Kenya: a modelling study.

BACKGROUND: Multiple prevention interventions, including early antiretroviral therapy initiation, may reduce HIV incidence in hyperendemic settings. Our aim was to predict the short-term impact of various single and combined interventions on HIV spreading in the adult population of Ndhiwa subcounty (Nyanza Province, Kenya). METHODS: A mathematical model was used with data on adults (15-59 years) from the Ndhiwa HIV Impact in Population Survey to compare the impacts on HIV prevalence, HIV incidence rate, and population viral load suppression of various interventions. These interventions included: improving the cascade of care (use of three guidelines), increasing voluntary medical male circumcision (VMMC), and implementing pre-exposure prophylaxis (PrEP) use among HIV-uninfected women. RESULTS: After four years, improving separately the cascade of care under the WHO 2013 guidelines and under the treat-all strategy would reduce the overall HIV incidence rate by 46 and 58 %, respectively, vs. the baseline rate, and by 35 and 49 %, respectively, vs. the implementation of the current Kenyan guidelines. With conservative and optimistic scenarios, VMMC and PrEP would reduce the HIV incidence rate by 15-25 % and 22-28 % vs. the baseline, respectively. Combining the WHO 2013 guidelines with VMMC would reduce the HIV incidence rate by 35-56 % and combining the treat-all strategy with VMMC would reduce it by 49-65 %. Combining the WHO 2013 guidelines, VMMC, and PrEP would reduce the HIV incidence rate by 46-67 %. CONCLUSIONS: The impacts of the WHO 2013 guidelines and the treat-all strategy were relatively close; their implementation is desirable to reduce HIV spread. Combining several strategies is promising in adult populations of hyperendemic areas but requires regular, reliable, and costly monitoring.

Diversity of the quality of data collection in a registry: proposal of an analysis approach and application to the REIN register / Diversité de la qualité de recueil des données dans un registre : proposition d'une démarche d'analyse et application au registre REIN

Missing data may lead to bias and loss of information in epidemiological research. In this article, we propose an approach to analyze missing data on comorbidity variables in a register with consideration of the territorialized organization of the collection. To illustrate this approach, we used the national REIN registry as an application case.

Les données manquantes peuvent introduire des biais et des pertes d'informations dans les études épidémiologiques. Dans cet article, nous proposons une démarche d'analyse des données manquantes sur des variables de comorbidités dans un registre, avec prise en compte de l'organisation territorialisée du recueil. Afin d'illustrer cette démarche, nous avons utilisé le registre national du Réseau épidémiologie et information en néphrologie (REIN) comme cas d'application.

Stronger Impact of COVID-19 in Nursing Homes of a French Region During the Second Pandemic Wave.

OBJECTIVES: Quantify the effects of characteristics of nursing homes and their surroundings on the spread of COVID-19 outbreaks and assess the changes in resident protection between the first 2 waves (March 1 to July 31 and August 1 to December 31, 2020). DESIGN: An observational study was carried out on data on COVID-19 outbreaks extracted from a database that monitored the spread of the virus in nursing homes. SETTING AND PARTICIPANTS: The study concerned all 937 nursing homes with >10 beds in Auvergne-Rhône-Alpes region, France. METHODS: The rate of nursing homes with at least 1 outbreak and the cumulative number of deaths were modeled for each wave. RESULTS: During the second (vs the first wave), the proportion of nursing homes that reported at least 1 outbreak was higher (70% vs 56%) and the cumulative number of deaths more than twofold (3348 vs 1590). The outbreak rate was significantly lower in public hospital-associated nursing homes than in private for-profit ones. During the second wave, it was lower in public and private not-for-profit nursing homes than in private for-profit ones. During the first wave, the probability of outbreak and the mean number of deaths increased with the number of beds (P < .001). During the second wave, the probability of outbreak remained stable in >80-bed institutions and, under proportionality assumption, the mean number of deaths was less than expected in >100-bed institutions. The outbreak rate and the cumulative number of deaths increased significantly with the increase in the incidence of hospitalization for COVID-19 in the surrounding populations. CONCLUSIONS AND IMPLICATIONS: The outbreak in the nursing homes was stronger during the second than the first wave despite better preparedness and higher availabilities of tests and protective equipment. Solutions for insufficient staffing, inadequate rooming, and suboptimal functioning should be found before future epidemics.

Is it possible to model the risk of malignancy of focal abnormalities found at prostate multiparametric MRI?

OBJECTIVE: To evaluate whether focal abnormalities (FAs) depicted by prostate MRI could be characterised using simple semiological features. METHODS: 134 patients who underwent T2-weighted, diffusion-weighted and dynamic contrast-enhanced MRI at 1.5 T before prostate biopsy were prospectively included. FAs visible at MRI were characterised by their shape, the degree of signal abnormality (0 = normal to 3 = markedly abnormal) on individual MR sequences, and a subjective score (SS(1) = probably benign to SS(3) = probably malignant). FAs were then biopsied under US guidance. RESULTS: 56/233 FAs were positive at biopsy. The subjective score significantly predicted biopsy results (P < 0.01). As compared to SS(1) FAs, the odds ratios (OR) of malignancy of SS(2) and SS(3) FAs were 9.9 (1.8-55.9) and 163.8 (11.5-2331). Unlike FAs' shape, a simple combination of MR signal abnormalities (into "low-risk", "intermediate" and "high-risk" groups) significantly predicted biopsy results (P < 0.008). As compared to "low risk" FAs, the OR of malignancy of "intermediate" and "high-risk" FAs were 4.5 (1.1-18.4) and 52.7 (6.8-407) in the overall population and 5.4 (1.1-27.2) and 118.2 (6.1-2301) in PZ. CONCLUSIONS: A simple combination of signal abnormalities of individual MR sequences can significantly stratify the risk of malignancy of FAs, holding promise of a more standardised interpretation of MRI by readers with varying experience. KEY POINTS: • Using multiparameter(mp)-MRI, experienced uroradiologists can stratify the malignancy risk of prostatic lesions • The shape of prostatic focal abnormalities in the peripheral zone does not help predicting malignancy. • A simple combination of findings at mp-MRI can help less-experienced radiologists.

COVID-19 outbreaks in nursing homes: A strong link with the coronavirus spread in the surrounding population, France, March to July 2020.

BACKGROUND: Worldwide, COVID-19 outbreaks in nursing homes have often been sudden and massive. The study investigated the role SARS-CoV-2 virus spread in nearby population plays in introducing the disease in nursing homes. MATERIAL AND METHODS: This was carried out through modelling the occurrences of first cases in each of 943 nursing homes of Auvergne-Rhône-Alpes French Region over the first epidemic wave (March-July, 2020). The cumulative probabilities of COVID-19 outbreak in the nursing homes and those of hospitalization for the disease in the population were modelled in each of the twelve Départements of the Region over period March-July 2020. This allowed estimating the duration of the active outbreak period, the dates and heights of the peaks of outbreak probabilities in nursing homes, and the dates and heights of the peaks of hospitalization probabilities in the population. Spearman coefficient estimated the correlation between the two peak series. RESULTS: The cumulative proportion of nursing homes with COVID-19 outbreaks was 52% (490/943; range: 22-70% acc. Département). The active outbreak period in the nursing homes lasted 11 to 21 days (acc. Département) and ended before lockdown end. Spearman correlation between outbreak probability peaks in nursing homes and hospitalization probability peaks in the population (surrogate of the incidence peaks) was estimated at 0.71 (95% CI: [0.66; 0.78]). CONCLUSION: The modelling highlighted a strong correlation between the outbreak in nursing homes and the external pressure of the disease. It indicated that avoiding disease outbreaks in nursing homes requires a tight control of virus spread in the surrounding populations.

Exposure of paediatric healthcare personnel to nitrous oxide in paediatric care units.

Nitrous oxide (N2O) was found responsible for genetic and reproductive toxicities, whereas it is widely used in paediatric care units where most healthcare providers are women of childbearing age. This motivated investigating occupational overexposure and overexposure factors in several paediatric hospital units. A cross-sectional study was carried out in seven healthcare units. On each of 34 healthcare providers, air samples were extracted (portable pumps and Tedlar® bags) and N2O quantified (gas chromatography, pulsed discharge ionization detection, and infrared spectrometry). The data allowed calculating mean instantaneous exposures. The mean instantaneous exposure was: i) four times higher in closed vs. open treatment rooms; ii) two times higher in case of use vs. non-use of N2O; iii) significantly higher in junior vs. senior healthcare providers (by 12%); and, iv) higher during presumably short vs. presumably long procedures (by 20%). Overexposures to N2O were mainly seen in the emergency unit and in day hospitals for thoracic/abdominal diseases and nephrology. Overexposures were frequent during short-duration procedures; among 88 N2O measurements, 77 (87.5%) exceeded the 200 ppm threshold over 15 minutes. The overexposures call for dedicated treatment rooms (with adequate equipment and ventilation), more efficient anaesthetic practices, appropriate training, and regular checks.

Comorbidities may offset expected improved survival after transcatheter aortic valve replacement.

Aims: After transcatheter aortic valve replacement (TAVR), cardiovascular and non-cardiovascular comorbidities may offset the survival benefit from the procedure. We aimed to describe the relationships between that benefit and patient comorbidities. Methods and results: The study pooled two European cohorts of patients with severe aortic stenosis (AS-pooled): one with patients who underwent (cohort of AS patients treated by TAVR, N = 233) and another with patients who did not undergo TAVR (cohort of AS patients treated medically; N = 291). The investigators collected the following: calcification prognostic impact (CAPRI) and Charlson scores for cardiovascular and non-cardiovascular comorbidities, activities of daily living (ADL)/instrumental activities of daily living (IADL) scores for frailty as well as routine Society of Thoracic Surgeons (STS) score and Logistic Euroscore. Unlike ADL/IADL scores, CAPRI and Charlson scores were found to be independent predictors of 1-year all-cause death in the AS-pooled cohort, with and without adjustment for STS score or Logistic Euroscore; they were thus retained to define a three-level prognostic scale (good, intermediate, and poor). The survival benefit from TAVR-vs. no TAVR-was stratified according to these three prognosis categories. The beneficial effect of TAVR on 1-year all-cause death was significant in patients with good and intermediate prognosis, hazard ratio (95% confidence interval): 0.36 (0.18; 0.72) and 0.32 (0.15; 0.67). That effect was reduced and not statistically significant in patient with poor prognosis [0.65 (0.22; 1.88)]. Conclusion: The study showed that, beyond a given comorbidity burden (as assessed by CAPRI and Charlson scores), the probability of death within a year was high and poorly reduced by TAVR. This indicates the futility of TAVR in patients in the poor prognosis category.

Impact of procedural success on clinical outcome after MitraClip: Results from the MITRA-FR trial.

BACKGROUND: Differences in procedural success rates have been proposed to explain the divergent results between the MITRA-FR trial (Percutaneous Repair with the MitraClip Device for Severe Functional/Secondary Mitral Regurgitation) and the COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation). AIM: To examine whether MITRA-FR patients who had successful clip implantation achieved a better outcome than the control group. METHODS: Based on the per protocol population of MITRA-FR, we compared the outcome in 71 patients in whom optimal clip implantation was achieved (group 1: mitral regurgitation grade ≤ 1 + at discharge) with that in 23 patients with non-optimal clip implantation (group 2: mitral regurgitation grade ≥ 2 + at discharge) and that in 137 patients in the control group (group 3). The primary endpoint was all-cause death or unplanned hospitalization for heart failure at 24 months. RESULTS: Event-free survival was not different across the groups (42±6% in group 1, 30±10% in group 2 and 31±4% in group 3; log-rank P=0.32). In multivariable analyses, after adjustment for age, sex, rhythm, aetiology, left ventricular ejection fraction and mitral regurgitation severity, group was not associated with variations in outcome: using Group 3 as reference, hazard ratio 0.86, 95% confidence interval 0.58-1.27 (P=0.43) in group 1; and hazard ratio 0.98 95% confidence interval 0.54-1.76 (P=0.94) in group 2. CONCLUSIONS: The clinical outcome of patients in whom optimal procedural result was achieved at discharge was not different compared with the control group. Our results do not support the hypothesis that the differences in rates of residual mitral regurgitation at discharge between MITRA-FR and COAPT explain the divergent results between the two trials.

Gain in net survival from hypertension control over the last half-century.

AIMS: This study determined whether the improvements in hypertension management over the last five decades have influenced subjects' prognosis. METHODS AND RESULTS: The study considered 5693 eligible subjects seen January 1969 to February 1991 (follow-up until December 2003) or January 1995 to October 2014 (follow-up until July 2016) in an all-grade hypertension reference centre. Missing data or incomplete follow-ups led to exclude 1036 subjects (18%). The outcome was all-cause death. An adjusted modelling of the excess mortality rate assessed subjects' net survival over five inclusion periods to allow for the increase in life expectancy of the general population during the same periods. The analysis of 4657 records (mean age: 47 years; 43.2% women) showed that the proportion of subjects with grade 3 hypertension decreased significantly from 43.3% (1142) to only 6.3% (22) over the five periods and that the net survival improved in men and women regardless of the hypertension grade; i.e. the gain in net survival at 15 years was estimated at 12.3% (95% confidence interval: 8.1-22.3). The 15-year restricted mean survival was estimated at 13 years over the first period and 14.8 years over the last period, which is nearly a 2-year gain in life expectancy at 15 years. CONCLUSION: Since the 70s and the advent of modern management, the excess mortality of hypertensive subjects (vs. the general population) was markedly reduced. Within a context of trivialization of blood pressure measurement and reluctance to long-term treatments, physicians should consider this advantage and use it to promote blood pressure control.

Detection of ISUP ≥2 prostate cancers using multiparametric MRI: prospective multicentre assessment of the non-inferiority of an artificial intelligence system as compared to the PI-RADS V.2.1 score (CHANGE study).

INTRODUCTION: Prostate multiparametric MRI (mpMRI) has shown good sensitivity in detecting cancers with an International Society of Urological Pathology (ISUP) grade of ≥2. However, it lacks specificity, and its inter-reader reproducibility remains moderate. Biomarkers, such as the Prostate Health Index (PHI), may help select patients for prostate biopsy. Computer-aided diagnosis/detection (CAD) systems may also improve mpMRI interpretation. Different prototypes of CAD systems are currently developed under the Recherche Hospitalo-Universitaire en Santé / Personalized Focused Ultrasound Surgery of Localized Prostate Cancer (RHU PERFUSE) research programme, tackling challenging issues such as robustness across imaging protocols and magnetic resonance (MR) vendors, and ability to characterise cancer aggressiveness. The study primary objective is to evaluate the non-inferiority of the area under the receiver operating characteristic curve of the final CAD system as compared with the Prostate Imaging-Reporting and Data System V.2.1 (PI-RADS V.2.1) in predicting the presence of ISUP ≥2 prostate cancer in patients undergoing prostate biopsy. METHODS: This prospective, multicentre, non-inferiority trial will include 420 men with suspected prostate cancer, a prostate-specific antigen level of ≤30 ng/mL and a clinical stage ≤T2 c. Included men will undergo prostate mpMRI that will be interpreted using the PI-RADS V.2.1 score. Then, they will undergo systematic and targeted biopsy. PHI will be assessed before biopsy. At the end of patient inclusion, MR images will be assessed by the final version of the CAD system developed under the RHU PERFUSE programme. Key secondary outcomes include the prediction of ISUP grade ≥2 prostate cancer during a 3-year follow-up, and the number of biopsy procedures saved and ISUP grade ≥2 cancers missed by several diagnostic pathways combining PHI and MRI findings. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Comité de Protection des Personnes Nord Ouest III (ID-RCB: 2020-A02785-34). After publication of the results, access to MR images will be possible for testing other CAD systems. TRIAL REGISTRATION NUMBER: NCT04732156.

A Nurse-Led Bridging Program to Reduce 30-Day Readmissions of Older Patients Discharged From Acute Care Units.

OBJECTIVES: Older hospitalized patients are at high risk of early readmissions, requiring the implementation of enhanced coordinated transition programs on discharge. The objective of this study was to evaluate the impact of a nurse-led transition bridging program on the rate of unscheduled readmissions of older patients within 30 days from discharge from geriatric acute care units. DESIGN: A stepped-wedge cluster randomized trial. SETTING AND PARTICIPANTS: Seven hundred five patients aged ≥75 years hospitalized in one of 10 acute geriatric units, with at least 2 readmission risk-screening criteria (derived from the Triage Risk Screening Tool), were included from July 2015 to August 2016. METHODS: The intervention condition consisted in a nurse-led hospital-to-home bridging program with 4 weeks postdischarge follow-up (2 home visits and 2 telephone calls). Unscheduled hospital readmission or emergency department (ED) visits were compared in intervention and control condition within 30 days from discharge. RESULTS: The rate of 30-day readmission or ED visit was 15.5% in the intervention condition vs 17.6% in the control condition [hazard ratio stratified on clusters: 0.61 (upper limit unilateral 95% confidence interval = 1.11), P = .09]. Rate of presence of professional caregivers was increased in the intervention condition (P < .001). CONCLUSIONS AND IMPLICATIONS: Although the intervention resulted in an increase in the rate of implementation of a package of care at the 4-week of follow-up, we could not demonstrate a reduction in the rate of 30-day readmissions or ED visits of older patients at risk of readmission. These findings support the evaluation of this type of program on the longer term.

Development and Validation of a Predictive Model of Hypovitaminosis D in General Adult Population: SCOPYD Study.

The worldwide global increase in serum 25-hydroxyvitamin D (25(OH)D) measurements has led some countries to restrict reimbursement for certain clinical situations only. Another approach could consist in providing physicians with screening tools in order to better target blood test prescription. The objective of the SCOPYD study was to identify the best combination of predictors of serum VitD concentration among adults aged 18-70 years. Potential risk factors for VitD deficiency were collected using a comprehensive self-administered questionnaire. A multivariable linear regression was used to build a predictive model of serum 25(OH)D concentration. Among 2488 participants, 1080 (43.4%) had VitD deficiency (<50 nmol/L) and 195 (7.8%) had severe deficiency (<25 nmol/L). The final model included sunlight exposure in the preceding week and during the last holidays, month of blood sampling, age, sex, body mass index, skin phototype, employment, smoking, sport practice, latitude, and VitD supplementation in preceding year. The area under the curve was 0.82 (95% CI (0.78; 0.85)) for severe deficiency. The model predicted severe deficiency with a sensitivity of 77.9% (95% CI (69.1; 85.7)) and a specificity of 68.3% (95% CI (64.8; 71.9)). We identified a set of predictors of severe VitD deficiency that are easy to collect in routine that may help to better target patients for serum 25(OH)D concentration determination.