Publications by authors named "Jean-Jacques Parienti"

180 Publications

Development of the "OS-SEV90 Score" to Predict Severe Postoperative Complications at 90 Days Following Bariatric Surgery.

Obes Surg 2021 Apr 28. Epub 2021 Apr 28.

Department of Digestive Surgery, University Hospital of Caen, Avenue de la côte de Nacre, 14033, Caen cedex, France.

Background: Bariatric surgery may be associated with severe postoperative complications (SPC). Factors associated with the risk of SPC have not been fully investigated.

Objectives: This study aimed to identify preoperative risk factors of SPC within 90 days and to develop a risk prediction model based on these factors.

Methods: We conducted a retrospective single-center cohort study based on a prospectively maintained database of obese patients undergoing laparoscopic bariatric surgery from October 2005 to May 2019. All SPC occurring up to the 90th postoperative day were recorded according to the Dindo-Clavien classification. Associations between potential risk factors and SPC were analyzed using a logistic regression model, and the risk prediction ("OS-SEV90 score") was computed. Based on the OS-SEV90 score, the patients were grouped into 3 categories of risk: low, intermediate, and high.

Results: Among 1963 consecutive patients, no patient died and 82 (4.2%) experienced SPC within 90 days. History of gastric or esophageal surgery (adjusted odds ratio (aOR) 3.040, 95% confidence interval; CI 1.78-5.20, p< 0.0001), past of thromboembolic event aOR 2.26, 95%; CI 1.12-4.55, p = 0.0225), and surgery performed by a junior surgeon (aOR 1.99, 95%; CI 1.26-3.13, p = 0.003) were all independently associated with risk for SPC, adjusting for ASA physical status system (ASA) score ≥ 3, severe OSA, psychiatric disease, asthma, a history of abdominal surgery, alcohol, cardiac disease, and dyslipidemia. "the OS-SEV90 score" based on these factors was constructed to classify patients into 3 risk groups: low (≤2), intermediate (3-4), and high (≥5). According to "the OS-SEV90 score," SPC increased significantly from 2.9% in the low-risk group, 7.7% in the intermediate-risk group, and 23.3% in the high-risk group.

Conclusions: A predictive model of SPC within 90 days "the OS-SEV90 score" has been developed using 9 baseline risk factors. The use of the OS-SEV90 score may help the multidisciplinary team to identify the specific risk of each patient and inform them about and optimize the comorbidities before the surgery. Further studies are warranted to validate this score in a new independent cohort before using it in clinical practice.
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http://dx.doi.org/10.1007/s11695-021-05367-0DOI Listing
April 2021

Ultrasound-guided catheterization and infectious risk in obese ICU patients.

Intensive Care Med 2021 Mar 27. Epub 2021 Mar 27.

INSERM, IAME, University of Paris, 75006, Paris, France.

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http://dx.doi.org/10.1007/s00134-021-06382-6DOI Listing
March 2021

Tenofovir disoproxil fumarate and emtricitabine maintenance strategy in virologically controlled adults with low HIV-1 DNA: 48 week results from a randomized, open-label, non-inferiority trial.

J Antimicrob Chemother 2021 03 16. Epub 2021 Mar 16.

Service des Maladies Infectieuses et Tropicales, CHR d'Orléans-La Source, Orléans, France.

Objectives: Low HIV reservoirs may be associated with viral suppression under a lower number of antiretroviral drugs. We investigated tenofovir disoproxil fumarate/emtricitabine as a maintenance strategy in people living with HIV (PLHIV) with low HIV-DNA.

Methods: TRULIGHT (NCT02302547) was a multicentre, open-label, randomized trial comparing a simplification to tenofovir disoproxil fumarate/emtricitabine versus a triple regimen continuation (tenofovir disoproxil fumarate/emtricitabine with a third agent, control arm) in virologically suppressed adults with HIV-DNA <2.7 log10 copies/106 PBMCs and no prior virological failure (VF). The primary endpoint (non-inferiority margin 12%) was the percentage of participants with a plasma viral load (pVL) <50 copies/mL in ITT (Snapshot approach) and PP analyses at Week 48 (W48).

Results: Of the 326 participants screened, 223 (68%) were randomized to the tenofovir disoproxil fumarate/emtricitabine arm (n = 113) or control arm (n = 110). At W48, the tenofovir disoproxil fumarate/emtricitabine and control arms maintained a pVL < 50 copies/mL in 100/113 (88.5%) and 100/110 (90.9%) participants, respectively (ITT difference 2.4%, 95% CI -5.9 to 10.7; PP difference 3.4%, 95% CI -4.2 to 11.0). Six VFs occurred in the tenofovir disoproxil fumarate/emtricitabine arm (two with emerging mutations M184V and K65R) versus two in the control arm (ITT difference 3.5%, 95% CI -1.9 to 9.4). All VFs were resuppressed after treatment modification.

Conclusions: Although non-inferiority was shown, simplification to tenofovir disoproxil fumarate/emtricitabine should not be used for most PLHIV because of a low risk of VF with resistance.
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http://dx.doi.org/10.1093/jac/dkab038DOI Listing
March 2021

Ability of procalcitonin to distinguish between bacterial and nonbacterial infection in severe acute exacerbation of chronic obstructive pulmonary syndrome in the ICU.

Ann Intensive Care 2021 Mar 6;11(1):39. Epub 2021 Mar 6.

Department of Biostatistics and Clinical Research, CHU de Caen, 14000, Caen, France.

Background: To assess the ability of procalcitonin (PCT) to distinguish between bacterial and nonbacterial causes of patients with severe acute exacerbation of COPD (AECOPD) admitted to the ICU, we conducted a retrospective analysis of two prospective studies including 375 patients with severe AECOPD with suspected lower respiratory tract infections. PCT levels were sequentially assessed at the time of inclusion, 6 h after and at day 1, using a sensitive immunoassay. The patients were classified according to the presence of a documented bacterial infection (including bacterial and viral coinfection) (BAC + group), or the absence of a documented bacterial infection (i.e., a documented viral infection alone or absence of a documented pathogen) (BAC- group). The accuracy of PCT levels in predicting bacterial infection (BAC + group) vs no bacterial infection (BAC- group) at different time points was evaluated by receiver operating characteristic (ROC) analysis.

Results: Regarding the entire cohort (n = 375), at any time, the PCT levels significantly differed between groups (Kruskal-Wallis test, p < 0.001). A pairwise comparison showed that PCT levels were significantly higher in patients with bacterial infection (n = 94) than in patients without documented pathogens (n = 218) (p < 0.001). No significant difference was observed between patients with bacterial and viral infection (n = 63). For example, the median PCT-H levels were 0.64 ng/ml [0.22-0.87] in the bacterial group vs 0.24 ng/ml [0.15-0.37] in the viral group and 0.16 ng/mL [0.11-0.22] in the group without documented pathogens. With a c-index of 0.64 (95% CI; 0.58-0.71) at H, 0.64 [95% CI 0.57-0.70] at H and 0.63 (95% CI; 0.56-0.69) at H, PCT had a low accuracy for predicting bacterial infection (BAC + group).

Conclusion: Despite higher PCT levels in severe AECOPD caused by bacterial infection, PCT had a poor accuracy to distinguish between bacterial and nonbacterial infection. Procalcitonin might not be sufficient as a standalone marker for initiating antibiotic treatment in this setting.
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http://dx.doi.org/10.1186/s13613-021-00816-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7936235PMC
March 2021

Obesity and risk of catheter-related infections in the ICU. A post hoc analysis of four large randomized controlled trials.

Intensive Care Med 2021 Apr 1;47(4):435-443. Epub 2021 Feb 1.

University of Paris, INSERM, IAME, 75006, Paris, France.

Purpose: Obesity increases the risk of nosocomial infection, but data regarding the role of body mass index (BMI) in catheter related infections are scarce. We used the data gathered from four randomized, controlled trials (RCTs) to investigate the association between body mass index (BMI) and intravascular catheter infections in critically ill obese patients.

Methods: Adult obese patients who required short-term central venous, arterial or dialysis catheter insertion in the intensive care unit (ICU) were analyzed. The association between BMI and major catheter-related infection (MCRI), catheter-related bloodstream infection (CRBSI) and catheter tip colonization was estimated using univariate and multivariate marginal Cox models. Exploratory analysis using dressing disruptions was added.

Results: A total of 2282 obese patients and 4275 catheters from 32 centers were included in this post-hoc analysis. Overall, 66 (1.5%) MCRI, 43 (1%) CRBSI and 399 (9.3%) catheter colonizations were identified. The hazard ratio (HR) for MCRI, CRBSI and colonization increased with BMI. After adjustment for well-known infection risk factors, the BMI ≥ 40 group had an increased risk for MCRI (HR 1.88, 95% CI 1.13-3.12, p = 0.015), CRBSI (HR 2.19, 95% CI 1.19-4.04, p = 0.012) and colonization (HR 1.44, 95% CI 1.12-1.84, p = 0.0038) compared to the BMI < 40 group. The mean dressing disruption per catheter was increased in the BMI ≥ 40 group (2.03 versus 1.68 in the BMI < 40 group, p = 0.05).

Conclusions: Using the largest dataset ever collected from large multicentric RCTs, we showed that patients with BMI ≥ 40 had an increased risk for intravascular catheter infections. Targeted prevention measures should focus on this population with a particular attention to catheter care and dressing disruption.
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http://dx.doi.org/10.1007/s00134-020-06336-4DOI Listing
April 2021

Ultrasound guidance and risk for central venous catheter-related infections in the ICU. A post hoc analysis of individual data of three multi-centric randomized trials.

Clin Infect Dis 2020 Dec 5. Epub 2020 Dec 5.

University of Paris, INSERM IAME, U1137, Team DesCID, Paris, France.

Background: Ultrasound (US) guidance is frequently used in critically ill patients for central venous catheter (CVC) insertion. The effect of US on infectious risk remains controversial and randomized-controlled trials (RCTs) assessed mainly non-infectious complications. This study assessed infectious risk associated with catheters inserted with US guidance versus use of anatomical 'landmarks' (AL).

Methods: We used individual data from three large RCTs for which a prospective, high-quality data collection was performed. Adult patients were recruited in various intensive care units (ICU) in France as soon as they required short-term CVC insertion. We applied marginal Cox models with inverse probability weighting to estimate the effect of US-guided insertion on catheter-related bloodstream infections (CRBSI, primary outcome) and major catheter-related infections (MCRI, secondary outcome).We also evaluated insertion site colonization at catheter removal.

Results: Our post hoc analysis included 4636 patients and 5502 catheters inserted in 2088 jugular, 1733 femoral and 1681 subclavian veins, respectively, in 19 ICUs. US was used for 2147 catheter insertions. Among jugular and femoral CVCs and after weighting, we found an association between US and CRBSI (HR 2.21, 95% CI 1.17-4.16, p=0.014) and between US and MCRI (HR 1.55, 95% CI 1.01-2.38, p=0.045). Catheter insertion site colonization at removal was more common in the US-guided group (p=0.0045) among jugular and femoral CVCs in situ for ≤7 days (n=606).

Conclusions: In prospectively collected data in which catheters were not randomized to insertion by US or AL, US guidance was associated with increased risk of infection.
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http://dx.doi.org/10.1093/cid/ciaa1817DOI Listing
December 2020

Mediators of anaphylactic reactions: Tryptase and histamine stability in whole blood.

Allergy 2021 May 2;76(5):1579-1583. Epub 2020 Dec 2.

Laboratoire d'Immunologie et Immunopathologie, Centre Hospitalier Universitaire de Caen, Caen, France.

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http://dx.doi.org/10.1111/all.14663DOI Listing
May 2021

Concurrent systemic antibiotics at catheter insertion and intravascular catheter-related infection in the ICU: a post hoc analysis using individual data from five large RCTs.

Clin Microbiol Infect 2020 Nov 2. Epub 2020 Nov 2.

University of Paris, INSERM, IAME, F-75006, Paris, France; Medical and Infectious Diseases Intensive Care Unit, AP-HP, Bichat-Claude Bernard University Hospital, 46 rue Henri Huchard, 75877, Paris Cedex, France.

Objectives: Data on the impact of systemic antibiotics at the time of catheter insertion are scarce. Therefore, we assessed the association between concurrent antibiotic administration at insertion and short-term catheter-related infections.

Methods: We used individual data gathered from five large, randomized, controlled ICU trials. We analysed adult patients who required arterial, short-term central venous or dialysis catheter insertion in the ICU. The effect of antibiotics at insertion on major catheter-related infection (MCRI), catheter-related bloodstream infection (CRBSI) and colonization was estimated using multivariate marginal Cox and propensity score models.

Results: We included 10 269 patients and 18 743 catheters from 36 ICUs. Antibiotic use was ongoing at the time of 11 361 catheter insertions (60.6%). After adjusting for well-known risk factors for intravascular catheter infection, we observed a similar risk for MCRI (HR 0.83, 95%CI 0.62-1.10, p 0.19) and CRBSI (HR 0.85, 95%CI 0.60-1.22, p 0.38) between the antibiotic and no-antibiotic groups. A confirmatory analysis using propensity score showed consistent results. No specific antibiotic subclasses reduced the risk of MCRI. Non-fermenting Gram-negative bacilli were more frequently observed in the antibiotic group.

Conclusions: Ongoing antibiotic administration at the time of catheter insertion was not associated with a decrease risk of catheter-related infections and should not be carried out for preventing such infections. Our results bring new insights to antimicrobial stewardship in critically ill patients and may direct empirical antimicrobial therapy if an intravascular catheter infection is suspected.
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http://dx.doi.org/10.1016/j.cmi.2020.10.026DOI Listing
November 2020

Incidence and risk factors for medical care interruption in people living with HIV in a French provincial city.

PLoS One 2020 15;15(10):e0240417. Epub 2020 Oct 15.

GRAM 2.0, EA2656, UNICAEN, Normandie University Hospital, Caen, France.

Objectives: The aim of our study was to identify HIV-positive patients at risk of medical care interruption (MCI) in a provincial city of a high-income country.

Methods: We estimated the incidence rate of MCI in 989 individuals followed in an HIV clinic in Caen University Hospital, Normandy, France, between January 2010 and May 2016. We enrolled patients over 18 years old who were seen at the clinic at least twice after HIV diagnosis. Patients were considered to be in MCI if they did not attend care in or outside the clinic for at least 18 months, regardless of whether or not they came back after interruption. We investigated sociodemographic, clinical and immunovirological characteristics at HIV diagnosis and during follow-up through a Cox model analysis.

Results: The incidence rate of MCI was estimated to be 3.0 per 100 persons-years (95% confidence interval [CI] = 2.6-3.5). The independent risk factors for MCI were a linkage to care >6 months after HIV diagnosis (hazard ratio [HR] = 1.14; 95% CI = 1.08-1.21), a hepatitis C coinfection (HR = 1.76; 95% CI = 1.07-2.88), being born in Sub-Saharan Africa (HR = 2.18; 95% CI = 1.42-3.34 vs. in France) and not having a mailing address reported in the file (HR = 1.73; 95% CI = 1.07-2.80). During follow-up, the risk of MCI decreased when the patient was older (HR = 0.28; 95% CI = 0.15-0.51 when >45 vs. ≤ 30 years old) and increased when the patient was not on antiretroviral therapy (HR = 2.78; 95% CI = 1.66-4.63).

Conclusions: Our findings show that it is important to link HIV-positive individuals to care quickly after diagnosis and initiate antiretroviral therapy as soon as possible to retain them in care.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0240417PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7561150PMC
December 2020

Adverse Drug Reaction Reporting Using a Mobile Device Application by Persons with Multiple Sclerosis: A Cluster Randomized Controlled Trial.

Drug Saf 2021 Feb 13;44(2):223-233. Epub 2020 Oct 13.

Clinical Research Department, Caen University Hospital, 14033, Caen Cedex 9, France.

Introduction: Patient reporting adds value to pharmacovigilance. Encouraging it to be done through a mobile device application (App) is a method that should be evaluated.

Objective: This study aimed to determine whether the use of an App, compared to traditional use through e-mail, telephone, or the national website, increased suspected adverse drug reaction (ADR) reporting by persons with multiple sclerosis receiving a first-line disease-modifying drug.

Methods: An open multi-centric, cluster-randomized controlled trial was conducted (VigipSEP study). Clusters were centers allocated (1:1) to the use of the My eReport France App (experimental arm), and traditional reporting (control arm). Persons with multiple sclerosis initiating or switching to a first-line disease-modifying drug between April 2017 and April 2019 were included. The primary outcome was the mean number of ADR reports per patient for the center-level analysis, and the number of ADR reports per patient for the individual-level analysis using the hierarchical Poisson regression model.

Results: Twenty-four centers (12 per arm: six public neurologists from the multiple sclerosis academic expert centers, three public neurologists from general hospitals, and three private practice neurologists) were randomized, including 159 patients. The mean number of ADR reports per patient was significantly higher in centers that used the App: 0.47 vs 0.03 in control centers (p = 0.002). At an individual-level analysis, the experimental arm was significantly associated with a relative risk of ADR reports at 18.6 (95% confidence interval 4.1-84.2; p < 0.001), compared to the control arm, adjusted for sex and type of disease-modifying drug.

Conclusions: The use of a mobile App increased the ADR reporting by persons with multiple sclerosis receiving a first-line disease-modifying drug. CLINICALTRIALS.

Gov Identifier: NCT03029897, registered in 2017.
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http://dx.doi.org/10.1007/s40264-020-01009-zDOI Listing
February 2021

Efficacy and safety of exenatide as add-on therapy for patients with type 2 diabetes with an intensive insulin regimen: A randomized double-blind trial.

Diabetes Obes Metab 2021 Feb 30;23(2):374-381. Epub 2020 Oct 30.

Diabetes Care Unit, Caen University Hospital, Caen, France.

Aim: To assess the safety and efficacy of the short-acting glucagon-like peptide-1 receptor agonist exenatide on a population of patients with type 2 diabetes (T2D) mostly treated with continuous subcutaneous insulin injection (CSII).

Materials And Methods: A phase 2/3, multicentre, randomized, parallel-group, double-blind, placebo-controlled, 6-month trial was conducted. Patients were randomized to receive subcutaneous (SC) injections of exenatide (10 μg BID) or matched placebo.

Results: A total of 46 patients with T2D and elevated HbA1c were randomized (42% of the planned sample size): exenatide (n = 28) and placebo (n = 18). CSII treatment was used by 75% and 89% of patients of the exenatide and placebo groups, respectively. At 6 months, the change in HbA1c was -0.62% ± 0.94% and 0.08% ± 0.81% in the exenatide and placebo groups, respectively (difference, -0.70%; 95% CI [-1.24%; -0.15%], P = .014); body weight and body mass index decreased in the exenatide group (-2.55 ± 3.25 kg and -1.00 ± 1.31 kg/m ) and increased in the placebo group (1.29 ± 2.82 kg and 0.46 ± 1.16 kg/m ) (observed difference, -3.85 and -1.45, respectively, both P < .001); the postdinner capillary blood glucose value was lower in the exenatide group compared with the placebo group (162.4 ± 80.5 vs. 259.1 ± 94.4 mg/dL, respectively; observed difference, -96.7, P < .01). Hypoglycaemic risk, quality of life and overall safety were not different between the groups, apart from the expected occurrence of digestive effects in the exenatide group.

Conclusions: Although we failed to reach our planned sample size, the addition of exenatide treatment 10 μg BID SC in T2D patients with uncontrolled HbA1c despite an intensified insulin regimen, resulted in a significant reduction of HbA1c and body weight with a good overall safety profile and acceptance.
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http://dx.doi.org/10.1111/dom.14225DOI Listing
February 2021

An Adherence-Enhancing Program Increases Retention in Care in the Swiss HIV Cohort.

Open Forum Infect Dis 2020 Sep 13;7(9):ofaa323. Epub 2020 Aug 13.

School of Pharmaceutical Sciences, University of Geneva, Geneva, Switzerland.

Background: This study tested a theory-based adherence-enhancing intervention: the "Interprofessional Medication Adherence Program" (IMAP) to increase human immunodeficiency virus (HIV) retention in care.

Methods: We retrospectively compared our intervention center (intervention group [IG]) with a standard of care center (control group [CG]) both participating in the Swiss HIV Cohort Study between 2004 and 2012. Endpoints were defined as >6-month and >12-month gaps in care for intervals of care longer than 6 and 12 months without any blood draw. Inverse probability of treatment weights was used to adjust for differences between patients at the 2 centers. Viral failure was defined as ribonucleic acid ≥50 copies/mL after 24+ weeks on antiretrovirals.

Results: The IG included 451 patients, CG 311. In the IG, 179 (40%) patients took part in the IMAP for a median of 27 months (interquartile range, 12-45). Gaps in care of ≥6 months were significantly more likely to happen in the CG versus IG (74.6% vs 57%, < .001). The median time until the first treatment gap was longer in the IG vs CG (120 vs 84 weeks, < .001). Gaps in care of ≥12 months evaluated in 709 (93%) patients were significantly more likely to occur in the CG compared with the IG (22.6% vs 12.5%, < .001). The rate of viral failure was significantly lower in the IG (8.3% vs 15.1%, = .003).

Conclusions: This study, in a real-world setting, shows the effectiveness of the IMAP to reduce 6- and 12-month gaps in follow up among people with HIV. These results should be confirmed by studies in other settings.
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http://dx.doi.org/10.1093/ofid/ofaa323DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7473741PMC
September 2020

Expert consensus-based clinical practice guidelines management of intravascular catheters in the intensive care unit.

Ann Intensive Care 2020 Sep 7;10(1):118. Epub 2020 Sep 7.

Surgical and Medical Intensive Care Unit Hôpital, Raymond Poincaré, 9230, Garches, France.

The French Society of Intensive Care Medicine (SRLF), jointly with the French-Speaking Group of Paediatric Emergency Rooms and Intensive Care Units (GFRUP) and the French-Speaking Association of Paediatric Surgical Intensivists (ADARPEF), worked out guidelines for the management of central venous catheters (CVC), arterial catheters and dialysis catheters in intensive care unit. For adult patients: Using GRADE methodology, 36 recommendations for an improved catheter management were produced by the 22 experts. Recommendations regarding catheter-related infections' prevention included the preferential use of subclavian central vein (GRADE 1), a one-step skin disinfection(GRADE 1) using 2% chlorhexidine (CHG)-alcohol (GRADE 1), and the implementation of a quality of care improvement program. Antiseptic- or antibiotic-impregnated CVC should likely not be used (GRADE 2, for children and adults). Catheter dressings should likely not be changed before the 7th day, except when the dressing gets detached, soiled or impregnated with blood (GRADE 2- adults). CHG dressings should likely be used (GRADE 2+). For adults and children, ultrasound guidance should be used to reduce mechanical complications in case of internal jugular access (GRADE 1), subclavian access (Grade 2) and femoral venous, arterial radial and femoral access (Expert opinion). For children, an ultrasound-guided supraclavicular approach of the brachiocephalic vein was recommended to reduce the number of attempts for cannulation and mechanical complications. Based on scarce publications on diagnostic and therapeutic strategies and on their experience (expert opinion), the panel proposed definitions, and therapeutic strategies.
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http://dx.doi.org/10.1186/s13613-020-00713-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7477021PMC
September 2020

Impacts of chest compression cycle length and real-time feedback with a CPRmeter® on chest compression quality in out-of-hospital cardiac arrest: study protocol for a multicenter randomized controlled factorial plan trial.

Trials 2020 Jul 8;21(1):627. Epub 2020 Jul 8.

Department of Anaesthesiology and Intensive Care, SAMU 76, Rouen University Hospital, Rouen Cedex, France.

Background: With a survival rate of 6 to 11%, out-of-hospital cardiac arrest (OHCA) remains a healthcare challenge with room for improvement in morbidity and mortality. The guidelines emphasize the highest possible quality of cardiopulmonary resuscitation (CPR) and chest compressions (CC). It is essential to minimize CC interruptions, and therefore increase the chest compression fraction (CCF), as this is an independent factor for survival. Survival is significantly and positively correlated with the suitability of CCF targets, CC frequency, CC depth, and brief predefibrillation pause. CC guidance improves adherence to recommendations and allows closer alignment with the CC objectives. The possibility of improving CCF by lengthening the time between two CC relays and the effect of real-time feedback on the quality of the CC must be investigated.

Methods: Using a 2 × 2 factorial design in a multicenter randomized trial, two hypotheses will be tested simultaneously: (i) a 4-min relay rhythm improves the CCF (reducing the no-flow time) compared to the currently recommended 2-min relay rate, and (ii) a guiding tool improves the quality of CC. Primary outcomes (i) CCF and (ii) correct compression score will be recorded by a real-time feedback device. Five hundred adult nontraumatic OHCAs will be included over 2 years. Patients will be randomized in a 1:1:1:1 distribution receiving advanced CPR as follows: 2-min blind, 2 min with guidance, 4-min blind, or 4 min with guidance. Secondary outcomes are the depth, frequency, and release of CC; length (care, no-flow, and low-flow); rate of return of spontaneous circulation; characteristics of advanced CPR; survival at hospital admission; survival and neurological state on days 1 and 30 (or intensive care discharge); and dosage of neuron-specific enolase on days 1 and 3.

Discussion: This study will contribute to assessing the impact of real-time feedback on CC quality in practical conditions of OHCA resuscitation. It will also provide insight into the feasibility of extending the relay rhythm between two rescuers from the currently recommended 2 to 4 min.

Trial Registration: ClinicalTrials.gov, NCT03817892 . Registered on 28 January 2019.
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http://dx.doi.org/10.1186/s13063-020-04536-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7346361PMC
July 2020

Relapses During High-Dose Biotin Treatment in Progressive Multiple Sclerosis: a Case-Crossover and Propensity Score-Adjusted Prospective Cohort.

Neurotherapeutics 2020 07;17(3):989-993

Department of Neurology, CHU de Caen, F-14000, Caen, France.

High-dose biotin (HDB) is a therapy used in non-active progressive multiple sclerosis (PMS). Some reports have suggested that HDB treatment may be associated with an increased risk of relapse. We evaluate the relationship between exposure to HDB for treating PMS and the risk of relapse. We screened for PMS patients prospectively registered in a French regional cohort being part of the OFSEP national registry. In a case-crossover design among patients who received HDB, we first compared number of relapses before and after initiation of HDB. Second, time to the first clinical relapse was compared between patients who received HDB (biotin group) and a control group using a Cox survival analysis after a propensity score (PS) matching (1:1) and inverse probability of treatment weighting (IPTW) method. In the 42 PMS patients who received HDB, the number of relapses was statistically and clinically significant higher after biotin initiation than before biotin initiation (incident rate ratio [IRR] 7.4, 95% confidence interval [CI] 3.5-15.9, p < 0.0001). With the PS matching method, the risk of relapse was significantly higher in the biotin group compared to the control group (hazard ratio [HR] 4.3, 95% CI 1.4-13.3, p = 0.01). The IPTW method with 440 control patients revealed consistent results (HR 5.1, 95% CI 2.3-11.3, p < 0.0001). In our non-randomized study, HDB treatment for PMS was associated with an increased risk of relapse. The follow-up of PMS patients initiating HDB should include careful assessment of clinical and radiological activity to monitor the potential pro-inflammatory effect of biotin.
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http://dx.doi.org/10.1007/s13311-020-00880-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7641290PMC
July 2020

Cardiovascular safety of rapidly accelerated fibrosarcoma B-type and/or mitogen-activated extracellular signal-regulated kinase inhibitors: A mixed approach combining a meta-analysis and a pharmacovigilance disproportionality analysis.

Arch Cardiovasc Dis 2020 Jun - Jul;113(6-7):420-432. Epub 2020 May 1.

Department of Pharmacology, CHU de Caen, 14000 Caen, France; Department of Cardiology, CHU de Caen, 14000 Caen, France; Department of Dermatology, CHU de Caen, 14000 Caen, France.

Background: The risk of cardiovascular adverse events from rapidly accelerated fibrosarcoma B-type (BRAF) and mitogen-activated extracellular signal-regulated kinase (MEK) inhibitors is not fully characterized.

Aim: To evaluate the cardiovascular adverse events risks related to BRAF and/or MEK inhibitors in randomized placebo-controlled clinical trials and in the real-life setting.

Methods: We used two approaches. First, we conducted a systematic review and meta-analysis of randomized placebo-controlled clinical trials reporting the incidence of cardiovascular adverse events for BRAF and/or MEK inhibitors in cancer patients. Second, we performed a disproportionality analysis, using age- and sex-adjusted reporting odds ratios (arORs) and their 95% confidence intervals (CIs) from the World Health Organization's pharmacovigilance database (VigiBase®) of anticancer drug-associated reports, to investigate real-life data.

Results: MEK inhibitors increased the risk of ejection fraction decrease (odds ratio [OR] 3.35, 95% CI 1.58-7.07), peripheral oedema (OR 2.87 95% CI 1.93-4.27) and syncope (OR 6.71, 95% CI 3.00-14.99) compared with placebo in randomized placebo-controlled clinical trials. BRAF and MEK inhibitor combination therapy further increased the risk of ejection fraction decrease. In the disproportionality analysis, we found over-reporting of ejection fraction decrease (arOR 8.42, 95% CI 7.03-10.09), peripheral oedema (arOR 1.39, 95% CI 1.17-1.66), syncope (arOR 1.56, 95% CI 1.22-1.99), torsade de pointes/QT prolongation (arOR 6.13, 95% CI 5.04-7.47) and supraventricular arrhythmias (arOR 1.50, 95% CI 1.21-1.85) for BRAF and MEK inhibitors. BRAF and MEK inhibitors were not associated with hypertension in either approach.

Conclusions: In conclusion, MEK inhibitors increase the risk of ejection fraction decrease, peripheral oedema and syncope in randomized placebo-controlled clinical trials. Real-life data confirm these findings, and suggested additional risks of torsade de pointes/QT prolongation and supraventricular arrhythmias with BRAF/MEK inhibitors.
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http://dx.doi.org/10.1016/j.acvd.2020.03.014DOI Listing
September 2020

Pseudomonas Causing Catheter Infection in the Groin Area: A New Reason to Avoid Femoral Lines?

Crit Care Med 2020 05;48(5):773-774

Department of Biostatistics and Clinical Research, Caen University Hospital; Department of Infectious Diseases, Caen University Hospital; and EA2656 Groupe de Recherche sur l'Adaptation Microbienne (GRAM 2.0), Université Caen Normandie, Caen, France EA2656 Groupe de Recherche sur l'Adaptation Microbienne (GRAM 2.0), Université Caen Normandie; and Department of Microbiology, Caen University Hospital, Caen, France Department of Medicine, Warren Alpert Medical School of Brown University; and Division of Infectious Diseases, Rhode Island Hospital, Providence, RI.

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http://dx.doi.org/10.1097/CCM.0000000000004296DOI Listing
May 2020

Individualized Fluid Management Using the Pleth Variability Index: A Randomized Clinical Trial.

Anesthesiology 2020 07;133(1):31-40

From the Anesthesiology and Critical Care Medicine Department (M.-O.F., S.L., W.G., G.D., J.-L.H.) the INSERM COMETE 1075 Unit, Orthopedic Department, (C.H.) the Biostatistics Department (J.-J.P.), Normandy University, Caen University Hospital, Caen, France Anesthesiology and Critical Care Medicine Department, Lille University Hospital, Lille, France (B.T., M.H.) Anesthesiology and Intensive Care Medicine Department, Hospital of Catholic Institute of Lille, Saint Philibert Hospital, Lomme, France (C.-E.B., V.C.) Anesthesiology and Critical Care Medicine Department, Rouen University Hospital, Charles Nicolle Hospital, Rouen, France (V.C.) Anesthesiology and Critical Care Department, Amiens University Hospital, Amiens, France (D.T., E.L.) Research Unit on Simplified Care of Complex Surgical Patients, Jules Verne University of Picardy, Amiens, France (E.L.). Caen University Hospital, Caen, France Caen University Hospital, Caen, France Amiens Picardie University Hospital, Amiens, France Amiens Picardie University Hospital, Amiens, France Lille University Hospital, Lille, France Lille University Hospital, Lille, France Hospital of Catholic Institute of Lille, Lomme, France Clinical Research Department, Caen University Hospital Clinical Research Department, Caen University Hospital Clinical Research Department, Caen University Hospital Clinical Research Department, Hospital of Catholic Institute of Lille Clinical Research Department, Lille University Hospital Clinical Research Department, Lille University Hospital Clinical Research Department, Amiens Picardie University Hospital.

Background: The present trial was designed to assess whether individualized strategies of fluid administration using a noninvasive plethysmographic variability index could reduce the postoperative hospital length of stay and morbidity after intermediate-risk surgery.

Methods: This was a multicenter, randomized, nonblinded parallel-group clinical trial conducted in five hospitals. Adult patients in sinus rhythm having elective orthopedic surgery (knee or hip arthroplasty) under general anesthesia were enrolled. Individualized hemodynamic management aimed to achieve a plethysmographic variability index under 13%, and the standard management strategy aimed to maintain a mean arterial pressure above 65 mmHg during general anesthesia. The primary outcome was the postoperative hospital length of stay decided by surgeons blinded to the group allocation of the patient.

Results: In total, 447 patients were randomized, and 438 were included in the analysis. The mean hospital length of stay ± SD was 6 ± 3 days for the plethysmographic variability index group and 6 ± 3 days for the control group (adjusted difference, 0.0 days; 95% CI, -0.6 to 0.5; P = 0.860); the theoretical postoperative hospital length of stay was 4 ± 2 days for the plethysmographic variability index group and 4 ± 1 days for the control group (P = 0.238). In the plethysmographic variability index and control groups, serious postoperative cardiac complications occurred in 3 of 217 (1%) and 2 of 224 (1%) patients (P = 0.681), acute postoperative renal failure occurred in 9 (4%) and 8 (4%) patients (P = 0.808), the troponin Ic concentration was more than 0.06 μg/l within 5 days postoperatively for 6 (3%) and 5 (2%) patients (P = 0.768), and the postoperative arterial lactate measurements were 1.44 ± 1.01 and 1.43 ± 0.95 mmol/l (P = 0.974), respectively.

Conclusions: Among intermediate-risk patients having orthopedic surgery with general anesthesia, fluid administration guided by the plethysmographic variability index did not shorten the duration of hospitalization or reduce complications.
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http://dx.doi.org/10.1097/ALN.0000000000003260DOI Listing
July 2020

Memory in autism spectrum disorder: A meta-analysis of experimental studies.

Psychol Bull 2020 05 19;146(5):377-410. Epub 2020 Mar 19.

Neuropsychology and Neuroimaging of Human Memory, University of Caen Normandy.

To address inconsistencies in the literature on memory in autism spectrum disorder (ASD), we report the first ever meta-analysis of short-term memory (STM) and episodic long-term memory (LTM) in ASD, evaluating the effects of type of material, type of retrieval and the role of interitem relations. Analysis of 64 studies comparing individuals with ASD and typical development (TD) showed greater difficulties in ASD compared with TD individuals in STM (Hedges' g = -0.53, 95% CI [-0.90, -0.16], = .005, I² = 96%) compared with LTM (g = -0.30, 95% CI [-0.42, -0.17], < .00001, I² = 24%), a small difficulty in verbal LTM (g = -0.21, = .01), contrasting with a medium difficulty for visual LTM (g = -0.41, = .0002) in ASD compared with TD individuals. We also found a general diminution in free recall compared with cued recall and recognition (LTM, free recall: g = -0.38, < .00001, cued recall: g = -0.08, = .58, recognition: g = -0.15, = .16; STM, free recall: g = -0.59, = .004, recognition: g = -0.33, = .07). We discuss these results in terms of their relation to semantic memory. The limited diminution in verbal LTM and preserved overall recognition and cued recall (supported retrieval) may result from a greater overlap of these tasks with semantic long-term representations which are overall preserved in ASD. By contrast, difficulties in STM or free recall may result from less overlap with the semantic system or may involve additional cognitive operations and executive demands. These findings highlight the need to support STM functioning in ASD and acknowledge the potential benefit of using verbal materials at encoding and broader forms of memory support at retrieval to enhance performance. (PsycInfo Database Record (c) 2020 APA, all rights reserved).
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http://dx.doi.org/10.1037/bul0000225DOI Listing
May 2020

On-demand PrEP efficacy: forgiveness or timely dosing.

Lancet HIV 2020 02 26;7(2):e79-e80. Epub 2019 Nov 26.

Department of Biostatistics and Clinical Research and Department of Infectious Diseases, Caen University Hospital, Caen 14000, France. Electronic address:

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http://dx.doi.org/10.1016/S2352-3018(19)30332-7DOI Listing
February 2020

Effects of Mineralocorticoid Receptor Antagonists on Atrial Fibrillation Occurrence: A Systematic Review, Meta-Analysis, and Meta-Regression to Identify Modifying Factors.

J Am Heart Assoc 2019 11 12;8(22):e013267. Epub 2019 Nov 12.

UNICAEN, CHU Caen Medical School Université Caen Normandie Caen France.

Background Mineralocorticoid receptor antagonists (MRAs) have emerged as potential atrial fibrillation (AF) preventive therapy, but inconsistent results have been reported. We aimed to examine the effects of MRAs on AF occurrence and explore factors that could influence the magnitude of the effect size. Methods and Results PubMed, Embase, and Cochrane Central databases were used to search for randomized clinical trials and observational studies addressing the effect of MRAs on AF occurrence from database inception through April 03, 2018. We performed a systematic review and random effects meta-analyses to compute odds ratios with 95% CIs. Meta-regression was then applied to explore the sources of between-study heterogeneity. We included 24 studies, 11 randomized clinical trials and 13 observational cohorts, representing a total number of 7914 patients (median age: 64.2 years; median left ventricular ejection fraction: 49.7%; median follow-up: 12.0 months), 2843 (35.9%) of whom received MRA therapy. Meta-analyses showed a significant overall reduction in AF occurrence in the MRA-treated patients versus the control groups (15.0% versus 32.2%; odds ratio, 0.55; 95% CI, 0.44-0.70 [<0.00001]), with the greatest benefit regarding recurrent AF episodes (odds ratio, 0.42; 95% CI, 0.31-0.59 [<0.00001]) and with significant heterogeneity among the included studies (=54%; =0.0008). Meta-regression analyses showed that effect size was significantly associated with older studies and higher AF occurrence rate in the control groups. Conclusions MRAs seem to be effective in AF prevention, especially regarding recurrent AF episodes.
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http://dx.doi.org/10.1161/JAHA.119.013267DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6915291PMC
November 2019

A head-to-head comparison of three coronary fractional flow reserve measurement technologies: The fractional flow reserve-device study.

Catheter Cardiovasc Interv 2020 05 12;95(6):1094-1101. Epub 2019 Aug 12.

Caen University Hospital, Caen, France.

Objectives: To compare three FFR technologies: the electric-sensor Pressurewire® (P), the optic-sensor Comet® (C) guidewire, and the optic-sensor Navvus® (N) microcatheter.

Background: Different technologies are used to measure fractional flow reserve (FFR) for the functional assessment of coronary lesions with potential discrepancies.

Methods: Sixty-six FFR measurements performed on 32 lesions using each technology were used for a paired comparison of FFR on simultaneous measurements and in clinically relevant conditions (guidewires alone, N on a guidewire).

Results: Simultaneous measurements of FFR were significantly (p < .0001) correlated between systems (ρ = 0.88, 0.81 and 0.86 for P and N, P and C and, C and N, respectively). The presence of the N microcatheter, led to reduced values of FFR measured by P or C guidewires (p < .0001). The concomitant presence of P and C guidewires led to significantly lower FFR values (p < .0001) measured by P but not by C. In clinically relevant conditions, values of FFR measured by the optic-sensor C guidewire and N catheter were similar and lower than those measured by the P guidewire (p < .0001). The agreement between the three technologies (FFR ≤ 0.80) was 94%.

Conclusions: FFR values simultaneously measured by three different technologies, are strongly correlated, and provide strongly concordant results. However, significant differences are found between values of FFR. The presence of N, but also C lead to a decrease of FFR measured by P. In clinically relevant conditions, the two optic-sensor technologies provide similar FFR measurements, lower than those measured by the piezo-electric technology suggesting a sensor-technology-related measurement variability.

Clinical Trial Registration: NCT#03052803.
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http://dx.doi.org/10.1002/ccd.28433DOI Listing
May 2020

Cushing's syndrome due to interaction between ritonavir or cobicistat and corticosteroids: a case-control study in the French Pharmacovigilance Database.

J Antimicrob Chemother 2019 11;74(11):3291-3294

Department of Biostatistics and Clinical Research, University Hospital of Caen Normandy, Caen, France.

Objectives: To explore the frequent interaction between antiretroviral-boosting agents and corticosteroids causing Cushing's syndrome (CS) in the French Pharmacovigilance Database (FPVD).

Methods: We conducted a retrospective case-control study describing CS recorded in the FPVD between 1996 and 2018. Case was defined as CS occurring in people living with HIV (PLWH) and control was defined as CS in uninfected individuals. Drug-drug interaction (DDI) was defined as an interaction between corticosteroids and CYP3A4 inhibitors. Data concerning the DDI, corticosteroids involved, route of administration and seriousness of the CS were described.

Results: Among the 139 instances of CS identified, 34/35 cases (97%) had DDIs (31 with ritonavir and 3 with cobicistat) and 7/104 controls (7%) had DDIs (6 with itraconazole and 1 with verapamil). The main corticosteroid involved was inhaled fluticasone (28/35, 80%) among the cases and oral prednisone (38/104, 37%) among the controls. More CS cases (30/35, 86%) than CS controls (62/104, 60%) were serious (OR = 4.0, 95% CI = 1.4-14.4; P = 0.007).

Conclusions: Antiretroviral-boosting agents were responsible for one out of four iatrogenic CS cases in a French national database. Prescribers should be aware of the risk of potentially serious DDIs between antiretroviral-boosting agents and corticosteroids, including single-tablet regimens containing cobicistat.
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http://dx.doi.org/10.1093/jac/dkz324DOI Listing
November 2019

Improving quality of care in patients with decompensated acute heart failure using a discharge checklist.

Arch Cardiovasc Dis 2019 Aug - Sep;112(8-9):494-501. Epub 2019 Jul 25.

Normandie Université, UNICAEN, CHU de Caen Normandie, Department of Cardiology, 14000 Caen, France.

Background: The use of a discharge checklist may decrease heart failure readmission rate.

Aims: We aimed to evaluate the usefulness of a checklist in patients hospitalized for heart failure, in terms of mortality, cardiovascular mortality and readmission rates, and quality of care, including therapeutic optimization and careplan planning.

Methods: We prospectively used a discharge checklist in 103 patients hospitalized for heart failure between July 2015 and January 2016. Quality of care and outcomes were compared with a retrospective cohort of 137 patients with same inclusion criteria, hospitalized between June 2014 and December 2014. The primary endpoints were total and cardiovascular mortality and readmissions for heart failure at 6months. The secondary endpoint was quality of care rendered, measured by evidence-based medications, appropriate medication uptitration and planned discharge care.

Results: At 6months, there were no differences between the checklist and control cohorts in the rates of all-cause mortality (10.7% vs. 13.1%; P=0.57), cardiovascular mortality (8.7% vs. 10.9%; P=0.58) and readmission (29.1% vs. 32.1%; P=0.62). Follow-up after discharge was better planned in the checklist group. The use of the checklist yielded therapeutic optimization with a higher dose of beta-blockers and renin-angiotensin-aldosterone system blockers, especially in patients with a reduced left ventricular ejection fraction (<50%) (P=0.03 and P=0.02, respectively).

Conclusions: The use of a simple discharge checklist in patients with acute heart failure showed no benefit in terms of readmission and mortality rates; however, it yielded better quality of care, including therapeutic optimization and careplan planning.
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http://dx.doi.org/10.1016/j.acvd.2019.05.003DOI Listing
November 2019

Spironolactone and perioperative atrial fibrillation occurrence in cardiac surgery patients: Rationale and design of the ALDOCURE trial.

Am Heart J 2019 08 9;214:88-96. Epub 2019 May 9.

Université Caen Normandie, Medical School, UNICAEN, CHU Caen, EA, 4650, Signalisation, électrophysiologie et imagerie des lésions d'ischémie-reperfusion myocardique, Caen F-14000, France; Department of Cardiology, CHU de Caen, Caen, F-14000, France.

Background: After artery bypass grafting (CABG), the presence of perioperative AF (POAF) is associated with greater short- and long-term cardiovascular morbidity. Underlying POAF mechanisms are complex and include the presence of an arrhythmogenic substrate, cardiac fibrosis and electrical remodeling. Aldosterone is a key component in this process. We hypothesize that perioperative mineralocorticoid receptor (MR) blockade may decrease the POAF incidence in patients with a left ventricular ejection fraction (LVEF) ≥50% who are referred for CABG with or without aortic valve replacement (AVR).

Study Design: The ALDOCURE trial (NCT03551548) will be a multicenter, randomized, double-blind, placebo-controlled trial testing the superiority of a low-cost MR antagonist (MRA, spironolactone) on POAF in 1500 adults referred for on-pump elective CABG surgery with or without AVR, without any history of heart failure or atrial arrhythmia. The primary efficacy end point is the occurrence of POAF from randomization to within 5 days after surgery, assessed in a standardized manner. The main secondary efficacy end points include the following: postoperative AF occurring within 5 days after cardiac surgery, perioperative myocardial injury, major cardiovascular events and death occurring within 30 days of surgery, hospital and intensive care unit length of stay, need for readmission, LVEF at discharge and significant ventricular arrhythmias within 5 days after surgery. Safety end points, including blood pressure, serum potassium levels and renal function, will be monitored regularly throughout the trial duration.

Conclusion: The ALDOCURE trial will assess the effectiveness of spironolactone in addition to standard therapy for reducing POAF in patients undergoing CABG.

Clinical Trial Registration: NCT03551548.
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http://dx.doi.org/10.1016/j.ahj.2019.04.023DOI Listing
August 2019

Different patterns and specific outcomes of large-vessel involvements in giant cell arteritis.

J Autoimmun 2019 09 24;103:102283. Epub 2019 May 24.

Department of Internal Medicine, Caen University Hospital, Caen, France; Normandie Univ, UNICAEN, CHU de Caen Normandie, 14000, Caen, France.

Large-vessel involvement (LVI) in giant cell arteritis (GCA) includes different clinical and imaging patterns that are rarely described separately at diagnosis and whose specific cardiovascular outcomes are unknown. We conducted a nationwide retrospective study and included GCA patients with LVI demonstrated on imaging at diagnosis between 2007 and 2017. We analyzed the prognosis of three different imaging patterns of LVI present at diagnosis, with some of them overlapping but with the first one present in all patients: 1) inflammation of the aorta and/or its branches; 2) dilation of the aorta; and 3) stenosis of the aortic branches. A control group of GCA patients without LVI was constituted. We included 183 patients with LVI and 105 controls without LVI. Altogether, among the 183 patients who all showed inflammation of the aorta and/or its main branches, concomitant aortic dilation and large-vessel stenosis were observed in 27 (15%) and 55 (30%) patients, respectively. During the follow-up period, new cardiovascular events occurred in 49% and 11% of LVI patients and controls, respectively (p < 0.0001). Inflammation of the aorta and/or its branches (HR: 3.42 [2.09-5.83], p < 0.0001) and large-artery stenosis (HR: 2.75 [1.80-4.15], p < 0.0001) were independent predictive factors of new cardiovascular events. Conversely, the use of an immunosuppressant besides corticosteroids was a protective factor against new cardiovascular events (HR: 0.44 [0.29-0.66], p < 0.0001) and the development of aortic dilation (HR: 0.43 [0.23-0.77], p = 0.005). This study suggests different forms of cardiovascular events according to the initial imaging pattern of LVI.
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http://dx.doi.org/10.1016/j.jaut.2019.05.011DOI Listing
September 2019

Risk and Cost Associated With Drug-Drug Interactions Among Aging HIV Patients Receiving Combined Antiretroviral Therapy in France.

Open Forum Infect Dis 2019 Mar 22;6(3):ofz051. Epub 2019 Mar 22.

Biostatistics and Clinical Research, Caen University Hospital, Caen, France.

Background: We aimed to describe the frequency, risk factors, and costs attributable to drug-drug interactions (DDIs) among an aging French HIV population.

Methods: We conducted a retrospective cohort study using French nationwide health care e-records: the SNIIRAM database. People living with HIV (PLWH) aged >65 years and receiving combined antiretroviral treatment (cART) during 2016 were included. A DDI was defined as "These drugs should not be co-administered," represented by a red symbol on the University of Liverpool website. Attributable DDIs' cost was defined as the difference between individuals with and without DDIs regarding all reimbursed health care acts.

Results: Overall, 9076 PLWH met the study criteria. Their baseline characteristics were: mean age, 71.3 ± 4.9 years; 25% female; median HIV duration (interquartile range [IQR]), 16.2 (9.5-20.3) years; median comorbidities (IQR), 2 (1-3). During 2016, they received a median (IQR) of 14 (9-21) comedications (non-cART), and 1529 individuals had at least 1 DDI (16.8%; 95% confidence interval [CI], 16.1-17.6). In multivariate analysis, raltegravir or dolutegravir plus 2 nucleoside reverse-transcriptase inhibitors (NRTIs) significantly and independently reduced the risk of DDIs (adjusted odds ratio [aOR], 0.02; 95% CI, 0.005-0.050; < .0001) compared with non-nucleoside reverse-transcriptase inhibitor plus 2 NRTIs, whereas cART with boosted agents (protease inhibitors or elvitegravir) significantly increased the risk (aOR, 4.12; 95% CI, 3.34-5.10; < .0001). Compared with propensity score-matched PLWH without DDIs, the presence of DDIs was associated with a $2693 additional cost per year ( < .0001).

Conclusions: The presence of DDIs is frequent and significantly increases health care costs in the aging population of PLWH.
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http://dx.doi.org/10.1093/ofid/ofz051DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6440683PMC
March 2019

Factors Associated with Relapse and Dependence on Glucocorticoids in Giant Cell Arteritis.

J Rheumatol 2020 01 15;47(1):108-116. Epub 2019 Mar 15.

From the Department of Internal Medicine, Department of Pathology, and Department of Biostatistics, Caen University Hospital, Caen, France.

Objective: To identify characteristics and factors associated with relapse and glucocorticoid (GC) dependence in patients with giant cell arteritis (GCA).

Methods: We retrospectively analyzed 326 consecutive patients with GCA followed for at least 12 months. Factors associated with relapse and GC dependence were identified in multivariable analyses.

Results: The 326 patients (73% women) were followed up for 62 (12-262) months. During followup, 171 (52%) patients relapsed, including 113 (35%) who developed GC dependence. Relapsing patients had less history of stroke (p = 0.01) and presented large-vessel vasculitis (LVV) more frequently on imaging (p = 0.01) than patients without relapse. During the first months, therapeutic strategy did not differ among relapsing and nonrelapsing patients. GC-dependent patients were less likely to have a history of stroke (p = 0.004) and presented LVV on imaging more frequently (p = 0.005) than patients without GC-dependent disease. In multivariable analyses, LVV was an independent predictive factor of relapse (HR 1.49, 95% CI 1.002-2.12; p = 0.04) and GC dependence (OR 2.19, 95% CI 1.19-4.05; p = 0.01). Conversely, stroke was a protective factor against relapse (HR 0.21, 95% CI 0.03-0.68; p = 0.005) and GC-dependent disease (OR 0.10, 95% CI 0.001-0.31; p = 0.0005). Patients with a GC-dependent disease who received a GC-sparing agent had a shorter GC treatment duration than those without (p = 0.008).

Conclusion: In this study, LVV was an independent predictor of relapse and GC dependence. Further prospective studies are needed to confirm these findings and to determine whether patients with LVV require a different treatment approach.
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http://dx.doi.org/10.3899/jrheum.181127DOI Listing
January 2020

Incidence of and risk factors for medical care interruption in people living with HIV in recent years.

PLoS One 2019 13;14(3):e0213526. Epub 2019 Mar 13.

IAME, UMR1137, INSERM, Paris Diderot University, Sorbonne Paris Cité, Paris, France.

Objectives: With HIV treatment as a prevention strategy, retention in care remains a key for sustained viral suppression. We sought to identify HIV-infected patients at risk for medical care interruption (MCI) in a high-income country.

Methods: The HIV-infected patients enrolled had to attend the clinic at least twice between January 2010 and October 2014 and were followed up until May 2016. MCI was defined as patients not seeking care in or outside the clinic for at least 18 months, regardless of whether they returned to care after the interruption. The association between MCI and sociodemographic, clinical, and immuno-virological characteristics at HIV diagnosis and during follow-up was assessed using Cox models.

Results: The incidence rate of MCI was 2.5 per 100 persons-years (95% confidence interval [CI] = 2.3-2.7). MCI was more likely in patients who accessed care >6 months after diagnosis (hazard ratio [HR] = 1.30, 95% CI = 1.10-1.54 vs. ≤6 months) or did not report a primary care physician (HR = 2.40; 95% CI = 2.03-2.84). MCI was less likely in patients born in sub-Saharan Africa (HR = 0.75, 95% CI = 0.62-0.91 vs. born in France). During follow-up, the risk of MCI increased when the last CD4 count was ≤350 (HR = 2.85, 95% CI = 2.02-4.04 vs. >500 cells/mm3) and when the patient was not on antiretroviral therapy (HR = 3.67, 95% CI = 2.90-4.66).

Conclusions: The incidence of MCI is low in this hospital that serves a large proportion of migrants. Low or no recorded CD4 counts for a medical visit could alert of a higher risk of MCI, even more in patients who accessed HIV care late or did not report a primary care physician.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0213526PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6415828PMC
December 2019