Clinical improvement after Essure® devices removal: a systematic review.

PURPOSE: Essure® implant is a permanently implanted minimally invasive birth control device for women (female sterilisation) widely used between 2002 and 2018. Many adverse events were reported by patients. Increasingly removal procedures have been performed in symptomatic patients. However, there is a lack of in-depth studies on clinical improvement after Essure® removal. We aimed to review all clinical studies about symptoms and quality of life (QoL) after removal procedures. MATERIALS AND METHODS: A review of literature in electronic search in Medline and Embase databases from January 2002 to January 2022 using the following keywords: Essure; Essure removal; quality of life; symptomatology improvement. RESULTS: Out of 764 articles in the initial database, 18 clinical studies were eligible for inclusion in our literature review. Overall clinical improvement rates after removal ranged from 21% to 98%. All symptoms were less frequent after Essure® removal, although with large discrepancies between studies. Lack of improvement was reported between 1% to 15% of patients. Rate of patients with improvement of QoL after removal ranged from 58 to 98%. The pain was reported as significantly reduced after the surgery. CONCLUSIONS: In the available literature, Essure® removal in symptomatic patients may improve symptoms and quality of life. This should be discussed in the benefits and risks ratio before deciding on the best option of management.

Essure® removal in symptomatic patients may improve symptoms and quality of life.

[Does aspirin have a place in primary cardiovascular prevention by the polypill ? Simulation study on a realistic virtual population]. / L'aspirine a-t-elle une place dans la prévention cardiovasculaire primaire par la polypill ? Étude de simulation sur une population virtuelle réaliste.

BACKGROUND: The polypill strategy could become widely accepted in cardiovascular prevention due to reduced costs and its simplicity, which promote compliance. Aspirin is often included as a component of the polypill for primary prevention, but three powerful recent trials failed to show any favorable net benefit even in high-risk subgroups. Our objective is to estimate the net benefit associated with aspirin in primary cardiovascular prevention. METHODS: We simulated the impact of different polypill compositions combining pravastatin, ramipril, hydrochlorothiazide, with or without aspirin, on a realistic French virtual population between 35 and 65 years old. We assessed how this impact on myocardial infarction and stroke varied according to gender, diabetes, and arterial hypertension. We identified the subgroup of individuals whose specific benefit from aspirin was greater than twice the risk of serious bleeding it induced. RESULTS: The absolute benefit associated with aspirin was reduced by co-prescriptions. No subgroup of women benefited from aspirin, and the subgroup of women with a clear net benefit represented 128 women out of 529,421. Men at high risk of cardiovascular death, or with diabetes and hypertension, had a benefit from aspirin exceeding the risk of bleeding induced, but this risk represented more than half of the benefit. No subgroup analyzed did show a benefit greater than twice the risk of bleeding. The proportion of men whose expected benefit from aspirin was greater than twice the risk of bleeding represented 3% of all men. An optimal polypill strategy in primary prevention between the ages of 35 and 65, combining three drugs but not aspirin, can hope to save two out of three strokes and more than one out of two myocardial infarctions. It would prevent a major cardiovascular accident every 16 to 193 individuals treated according to the subgroups considered. CONCLUSION: Until proven otherwise, aspirin has only a limited place in individuals between 35 and 65 years without a cardiovascular history. We showed how simulating therapeutic strategies on a realistic virtual population could be used for best applying available evidence.

Population designations in biomedical research: Limitations and perspectives.

In biomedical research, population differences are of central interest. Variations in the frequency and severity of diseases and in treatment effects among human subpopulation groups are common in many medical conditions. Unfortunately, the practices in terms of subpopulation labeling do not exhibit the level of rigor one would expect in biomedical research, especially when studying multifactorial diseases such as cancer or atherosclerosis. The reporting of population differences in clinical research is characterized by large disparities in practices, and fraught with methodological issues and inconsistencies. The actual designations such as "Black" or "Asian" refer to broad and heterogeneous groups, with a great discrepancy among countries. Moreover, the use of obsolete concepts such as "Caucasian" is unfortunate and imprecise. The use of adequate labeling to reflect the scientific hypothesis needs to be promoted. Furthermore, the use of "race/ethnicity" as a unique cause of human heterogeneity may distract from investigating other factors related to a medical condition, particularly if this label is employed as a proxy for cultural habits, diet, or environmental exposure. In addition, the wide range of opinions among researchers does not facilitate the attempts made for resolving this heterogeneity in labeling. "Race," "ethnicity," "ancestry," "geographical origin," and other similar concepts are saturated with meanings. Even if the feasibility of a global consensus on labeling seems difficult, geneticists, sociologists, anthropologists, and ethicists should help develop policies and practices for the biomedical field.

Bites by Non-Native Reptiles in France: Species, Circumstances and Outcome.

We aimed to make an exhaustive assessment of circumstances of bites by exotic reptiles bred in France. A retrospective observational study was conducted in all the reported cases from 2000 to 2020 in French poison control centers (PCCs). Two hundred and eighteen cases of bites were recorded. The sex ratio (M/F) of the patients was 1.79 and the mean age of the patients was 29.0 ± 15.8 years. Twenty-two cases (10.1%) occurred during the deep night. One hundred and eighty-six bites (85.7%) occurred in a private context; however, there were more cases of high severity when it occurred in a professional setting (60.0% vs. 11.2%, p < 0.01). The feeding/nursing activity accounted for 54.7% cases. Forty-three species of snake were identified; 28 were considered venomous. There were no deaths among the patients in the study. Most of the cases (85.8%) were of mild severity. All of the patients bitten by a venomous reptile were hospitalized: 10 patients received an antivenom; and 2 required surgery. Bites occurred at home and by a small number of popular non-venomous reptile species (pythons and boas, colubrids). These occurred mainly when handling the animals. The rare envenomations were mainly by Asian and American crotalids, followed by elapids. One-third of them were treated with antivenom when available.

Reappraisal of the efficacy of intensive glycaemic control on microvascular complications in patients with type 2 diabetes: A meta-analysis of randomised control-trials.

OBJECTIVE: To re-assess the effect of tight glycaemic control on diabetic microvascular complications. METHOD: Meta-analysis and trial sequential analyses of randomised trials included in Hemmingsen et al that specifically assessed glycaemic control with a specific HbA1c level targeted in the intervention group, and compared intensive glycaemic control versus standard glycaemic control. RESULTS: Seven clinical trials that randomised 28,614 participants with type 2 diabetes (15,269 to intensive control and 13,345 to conventional control), including 3 sub-studies, were included. Strict control of blood glucose levels is associated with a reduction of retinopathy progression (RR=0.77, 95% CI: 0.66-0.89, I2=33%), incidence or progression of macular oedema (RR=0.66, 95% CI: 0.40-0.99, I2=0%), number of photocoagulations (RR=0.84, 95% CI: 0.73-0.97, I2=0%), risk of microalbuminuria (RR=0.76, 95% CI: 0.64-0.9, I2=76%) and risk of "macroalbuminuria or proteinuria" (RR=0.68, 95% CI: 0.55-0.85, I2=36%). CONCLUSION: This meta-analysis has shown that a tight control of blood glucose levels is associated with a decrease of specific microvascular complication of diabetes: photocoagulation, progression of diabetic retinopathy, incidence or progression of macular oedema, risk of microalbuminuria and risk of macroalbuminuria or proteinuria. Regarding all the other outcomes (vision loss, surgery of cataract, proliferative or non-proliferative retinopathy, death related to kidney disease, development of kidney disease, doubling of serum creatinine, neuropathy), no significant result was found.

Meta-regression of randomized control trials with antithrombotics: weak correlation between net clinical benefit and all cause-mortality.

This study aimed to explore the validity of the use of the net clinical benefit (NCB), i.e. the sum of major bleeding and thrombotic events, as a potential surrogate for all-cause mortality in clinical trials assessing antithrombotics. Published randomized controlled trials testing anticoagulants in the prevention or treatment of venous thromboembolism (VTE) and non-valvular atrial fibrillation (NVAF) were systematically reviewed. The validity of NCB as a surrogate endpoint was estimated by calculating the strength of correlation of determination (R2) and its 95% confidence interval (CI) between the relative risks of NCB and all-cause mortality. Amongst the 125 trials retrieved, the highest R2trial values were estimated for NVAF (R2trial = 0.41, 95% CI [0.03; 0.48]), and acute VTE (R2trial = 0.30, 95% CI [0.04; 0.84]). Conversely, the NCB did not correlate with all-cause mortality in prevention studies with medical (R2trial = 0.12, 95% CI [0.00; 0.36]), surgical (R2trial = 0.05, 95% CI [0.00; 0.23]), and cancer patients (R2trial = 0.006, 95% CI [0.00; 1.00]). A weak correlation between NCB and all cause-mortality was found in NVAF and acute VTE, whereas no correlation was observed in clinical situations where the mortality rate was low. Consequently, NCB should not be considered a surrogate outcome for all cause-mortality in anticoagulation trials.

Protocol of GLUcose COntrol Safety and Efficacy in type 2 DIabetes, a NETwork meta-analysis: GLUCOSE DINET protocol-Rational and design.

The aim of this study was to propose a ranking of the currently available antidiabetic drugs, regarding vascular clinical outcomes, in patients with type 2 diabetes, through a network meta-analysis approach. Randomized clinical trials, regardless of the blinding design, testing contemporary antidiabetic drugs, and considering clinically relevant outcomes in patients with type 2 diabetes mellitus will be included. The primary outcomes of this analysis will be overall mortality, cardiovascular mortality, and major cardiovascular events. Diabetic microangiopathy will be a secondary outcome. Adverse events, hypoglycemia, weight evolution, bariatric surgery, and discontinuation of the treatment will also be recorded. Each drug will be analyzed according to its therapeutic class: biguanide, alpha-glucosidase inhibitors, sulfonylureas, glitazones, glinides, insulin, DPP-4 inhibitors, GLP-1 analogs, and gliflozins. The treatment effect of each drug class will be compared using pairwise meta-analysis and a Bayesian random model network meta-analysis. Sensitivity analyses will be conducted according to the quality of the studies and the glycemic control. The report will follow the PRISMA checklist for network meta-analysis. Results of the search strategy and of the study selection will be presented in a PRISMA compliant flowchart. The treatment effects will be summarized with odds ratio (OR) estimates and their 95% credible intervals. A ranking of the drugs will be proposed. Our network meta-analysis should allow a clinically relevant ranking of the contemporary antidiabetic drugs.