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Background. Due to its antioxidant, anti-inflammatory, anti-apoptosis, and anti-fatigue properties, molecular hydrogen (H2) is potentially a novel therapeutic nutrient for patients with coronavirus acute disease 2019 (COVID-19). We determined the efficacy and safety profile of hydrogen-rich water (HRW) to reduce the risk of COVID-19 progression. Methods: We also conducted a phase 3, triple-blind, randomised, placebo-controlled trial to evaluate treatment with HRW initiated within 5 days after the onset of signs or symptoms in primary care patients with mild-to-moderate, laboratory-confirmed COVID-19. Participants were randomised to receive HRW or placebo twice daily for 21 days. The incidence of clinical worsening and adverse events were the primary endpoints. Results: A total of 675 participants were followed up to day 30. HRW was not superior to placebo in preventing clinical worsening at day 14: in H2 group, 46.1% in the H2 group, 43.5% in the placebo group, hazard ratio 1.09, 90% confidence interval [0.90-1.31]. One death was reported at day 30 in the H2 group and two in the placebo group at day 30. Adverse events were reported in 91 (27%) and 89 (26.2%) participants, respectively. Conclusions: HRW taken twice daily from the onset of COVID-19 symptoms for 21 days did not reduce clinical worsening.
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OBJECTIVES: We investigated the sex-related difference in characteristics and 2-year outcomes after surgical aortic valve replacement (SAVR) by propensity-score matching (PSM). METHODS: Data from 2 prospective registries, the INSPIRIS RESILIA Durability Registry (INDURE) and IMPACT, were merged, resulting in a total of 933 patients: 735 males and 253 females undergoing first-time SAVR. The PSM was performed to assess the impact of sex on the SAVR outcomes, yielding 433 males and 243 females with comparable baseline characteristics. RESULTS: Females had a lower body mass index (median 27.1 vs 28.0 kg/m2; P = 0.008), fewer bicuspid valves (52% vs 59%; P = 0.036), higher EuroSCORE II (mean 2.3 vs 1.8%; P < 0.001) and Society of Thoracic Surgeons score (mean 1.6 vs 0.9%; P < 0.001), were more often in New York Heart Association functional class III/IV (47% vs 30%; P < 0.001) and angina Canadian Cardiovascular Society III/IV (8.2% vs 4.4%; P < 0.001), but had a lower rate of myocardial infarction (1.9% vs 5.2%; P = 0.028) compared to males. These differences vanished after PSM, except for the EuroSCORE II and Society of Thoracic Surgeons scores, which were still significantly higher in females. Furthermore, females required smaller valves (median diameter 23.0 vs 25.0 mm, P < 0.001). There were no differences in the length of hospital stay (median 8 days) or intensive care unit stay (median 24 vs 25 hours) between the 2 sexes. At 2 years, post-SAVR outcomes were comparable between males and females, even after PSM. CONCLUSIONS: Despite females presenting with a significantly higher surgical risk profile, 2-year outcomes following SAVR were comparable between males and females.
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INTRODUCTION: Long-term adherence to continuous positive airway pressure (CPAP) therapy for obstructive sleep apnoea remains suboptimal and low adherence increases healthcare costs. This study investigated relationships between CPAP adherence and the intensity of support provided by homecare providers after implementation of telemonitoring and pay-for-performance reimbursement for CPAP in France. METHODS: Adults who started CPAP in 2018/2019, used telemonitoring, and had ≥1 year of homecare provider data were eligible. The main objective was to determine associations between CPAP adherence at 1 month (low [<2h/night], intermediate [2 to <4h/night], high [≥4h/night]) and the number/type of homecare provider interactions (home visits, phone calls, mask change) during the first year. RESULTS: Eleven thousand, one hundred sixty-six individuals were included (mean age 59.8±12.7 years, 67% male). The number of homecare provider interactions per person increased significantly as 1-month CPAP usage decreased (7.65±4.3, 6.5±4.0, 5.4±3.4 in low, intermediate and high adherence groups; p<0.01). There was marked improvement in device usage over the first 5-6 months of therapy in the low and intermediate adherence subgroups (p<0.05 after adjustment for age, sex, initial CPAP adherence, and number of interactions). After adjustment for age, sex and 1-month adherence, having 3-4 interactions was significantly associated with better 1-year adherence (odds ratio 1.24, 95% confidence interval 1.05-1.46), while having >7 interactions was significantly associated with worse 1-year adherence. CONCLUSIONS: The telemonitoring/reimbursement scheme in France had a positive impact on CPAP adherence and facilitated a more personalised approach to therapy management, focusing resources on patients with low and intermediate adherence.
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BACKGROUND: European and U.S. clinical guidelines diverge regarding pulmonary hypertension (PHTN) in degenerative mitral regurgitation (DMR). Gaps in knowledge underpinning these divergences affect risk assessment and management recommendations attached to systolic pulmonary pressure (SPAP) in DMR. OBJECTIVES: This study sought to define PHTN links to DMR severity, prognostic thresholds, and independent outcome impact in a large quantitative DMR registry. METHODS: This study gathered a large multicentric registry of consecutive patients with isolated moderate-to-severe DMR, with DMR and SPAP quantified prospectively at diagnosis. RESULTS: In 3,712 patients (67 ± 15 years, 36% women) with ≥ moderate-to-severe DMR, effective regurgitant orifice (ERO) was 0.42 ± 0.19 cm2, regurgitant volume 66 ± 327 mL/beat and SPAP 41 ± 16 mm Hg. Spline-curve analysis showed excess mortality under medical management emerging around SPAP 35 mm Hg and doubling around SPAP 50 mm Hg. Accordingly, severe pulmonary hypertension (sPHTN) (SPAP ≥50 mm Hg) was detected in 916 patients, moderate pulmonary hypertension (mPHTN) (SPAP 35-49 mm Hg) in 1,128, and no-PHTN (SPAP <35 mm Hg) in 1,668. Whereas SPAP was strongly associated with DMR-ERO, nevertheless excess mortality with sPHTN (adjusted HR: 1.65; 95% CI: 1.24-2.20) and mPHTN (adjusted HR: 1.44; 95% CI: 1.11-1.85; both P ≤ 0.005) was observed independently of ERO and all baseline characteristics and in all patient subsets. Nested models demonstrated incremental prognostic value of mPHTN and sPHTN (all P < 0.0001). Despite higher operative risk with mPHTN and sPHTN, DMR surgical correction was followed by higher survival in all PHTN ranges with strong survival benefit of early surgery (<3 months). Postoperatively, excess mortality was abolished (P ≥ 0.30) in mPHTN, but only abated in sPHTN. CONCLUSIONS: This large international registry, with prospectively quantified DMR and SPAP, demonstrates a Doppler-defined PHTN impact on mortality, independent of DMR severity. Crucially, it defines objectively the new and frequent mPHTN range, independently linked to excess mortality under medical management, which is abolished by DMR correction. Thus, at DMR diagnosis, Doppler-SPAP measurement defining these new PHTN ranges, is crucial to guiding DMR management.
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INTRODUCTION: Monitoring changes in symptoms over time during long-term nocturnal home non-invasive ventilation (NIV) using patient-reported outcome measures is crucial. This study aimed to identify factors associated with changes in the S3-NIV total score, its two domains ("respiratory symptoms" and "sleep and NIV-related side effects") and individual item responses. METHODS: We conducted a retrospective, longitudinal data analysis of a cohort of adults with chronic respiratory failure treated with NIV. Data were obtained from a French homecare provider. Multivariate linear and multinomial ordinal mixed effect models were used to identify factors associated with changes in S3-NIV scores over time. RESULTS: Median follow-up was 2 years for 2135 participants. Each participant completed a median of five S3-NIV questionnaires; totaling 11,359 analyzed questionnaires. Type of respiratory condition, sex, age and time since NIV initiation were associated with change in S3-NIV score over time. NIV adherence was not associated with total S3-NIV score but high adherence was associated with more severe respiratory symptoms and an improvement in sleep and NIV-related side effects during the follow-up. Intensity of pressure support was associated with a lower total S3-NIV score and more side effects. Face masks and supplemental oxygen were associated with a lower S3-NIV total score. CONCLUSION: Changes in S3-NIV scores over time are associated with the individual's characteristics and NIV settings. Analysis of the two domains and individual items of the S3-NIV could increase understanding of the difficulties experienced by people on NIV.
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Home Care Services , Noninvasive Ventilation , Respiratory Insufficiency , Humans , Male , Female , Respiratory Insufficiency/therapy , Retrospective Studies , Aged , Middle Aged , Chronic Disease , Longitudinal Studies , Patient Reported Outcome Measures , Patient Compliance , Time Factors , Aged, 80 and over , Adult , FranceABSTRACT
AIMS: Aortic valve calcification (AVC) of surgical valve bioprostheses (BPs) has been poorly explored. We aimed to evaluate in vivo and ex vivo BP AVCs and its prognosis value. METHODS AND RESULTS: Between 2011 and 2019, AVC was assessed using in vivo computed tomography (CT) in 361 patients who had undergone surgical valve replacement 6.4 ± 4.3 years earlier. Ex vivo CT scans were performed for 37 explanted BPs. The in vivo CT scans were interpretable for 342 patients (19 patients [5.2%] were excluded). These patients were 77.2 ± 9.1 years old, and 64.3% were male. Mean in vivo AVC was 307 ± 500â Agatstonâ units (AU). The AVC was 562 ± 570â AU for the 183 (53.5%) patients with structural valve degeneration (SVD) and 13 ± 43â AU for those without SVD (P < 0.0001). In vivo and ex vivo AVCs were strongly correlated (r = 0.88, P < 0.0001). An in vivo AVC > 100â AU (n = 147, 43%) had a specificity of 96% for diagnosing Stage 2-3 SVD (area under the curve = 0.92). Patients with AVC > 100â AU had a worse outcome compared with those with AVC ≤ 100â AU (n = 195). In multivariable analysis, AVC was a predictor of overall mortality (hazard ratio [HR] and 95% confidence interval = 1.16 [1.04-1.29]; P = 0.006), cardiovascular mortality (HR = 1.22 [1.04-1.43]; P = 0.013), cardiovascular events (HR = 1.28 [1.16-1.41]; P < 0.0001), and re-intervention (HR = 1.15 [1.06-1.25]; P < 0.0001). After adjustment for Stage 2-3 SVD diagnosis, AVC remained a predictor of overall mortality (HR = 1.20 [1.04-1.39]; P = 0.015) and cardiovascular events (HR = 1.25 [1.09-1.43]; P = 0.001). CONCLUSION: CT scan is a reliable tool to assess BP leaflet calcification. An AVC > 100â AU is tightly associated with SVD and it is a strong predictor of overall mortality and cardiovascular events.
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Aortic Valve , Bioprosthesis , Calcinosis , Heart Valve Prosthesis , Tomography, X-Ray Computed , Humans , Male , Female , Aged , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Aortic Valve/pathology , Calcinosis/diagnostic imaging , Calcinosis/surgery , Tomography, X-Ray Computed/methods , Retrospective Studies , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/diagnostic imaging , Heart Valve Prosthesis Implantation/methods , Prognosis , Treatment Outcome , Postoperative Complications/diagnostic imagingABSTRACT
Cameroon introduced the malaria vaccine in its routine immunization program on 22 January 2024 in the 42 districts out of 200 that are among the most at risk of malaria. A cross-sectional analysis of the data on key vaccine events in the introduction roadmap and the vaccine uptake during the first 30 days was conducted. In addition to available gray literature related to the introduction of the malaria vaccine, data on the malaria vaccine uptake by vaccination session, collected through a digital platform, were analyzed. A total of 1893 reports were received from 22 January 2024 to 21 February 2024 from 766 health facilities (84% of overall completeness). Two regions out of ten recorded less than 80% completeness. As of 21 February 2024, 13,811 children had received the first dose of the malaria vaccine, including 7124 girls (51.6%) and 6687 boys (48.4%). In total, 36% of the children were vaccinated through outreach sessions, while 61.5% were vaccinated through sessions in fixed posts. The overall monthly immunization coverage with the first dose was 37%. Early results have shown positive attitudes towards and acceptance of malaria vaccines. Suboptimal completeness of data reporting and a low coverage highlight persistent gaps and challenges in the vaccine rollout.
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INTRODUCTION: Obstructive sleep apnoea syndrome (OSAS) is a chronic multiorgan pathology that has a negative impact on quality of life. Continuous positive airway pressure (CPAP) is the first-line treatment for OSAS. However, CPAP termination rates remain very high, and adherence to therapy is a major issue. To date, studies targeting predictive factors of CPAP adherence by OSAS patients mainly include clinical data. The social, socioeconomic, psychological, and home environment aspects have been far less studied and largely underestimated. This study aims to obtain solid quantitative results examining the relationship between the determinants of refusal, non-adherence, or termination of CPAP treatment, and in particular the pivotal role played by health literacy. METHODS AND ANALYSIS: This is a prospective, multicentre, observational study recruiting patients attending the sleep clinic of the Grenoble Alpes University Hospital, France. Consecutive adults (>18 years) recently diagnosed with OSAS and prescribed CPAP treatment with telemonitoring will be enrolled in the present study. They will benefit from home visits by a CPAP technician or nurse at CPAP initiation. Patients will then be followed up for 6 months through the telemonitoring platform of a home-care provider. The primary objective is to evaluate the impact of health literacy (health literacy, measured by the European Health Literacy Survey questionnaire (HLS-EU-16) on the refusal, non-adherence or termination of CPAP treatment in newly diagnosed OSAS patients, during the first 6 months after diagnosis. The target sample size is 250 participants. ETHICS AND DISSEMINATION: The study protocol, patient information, and the non-opposition form were approved by the French national ethics committee (CPP 2021-92, January 2022). All patients are required to have signed a written informed consent form permitting their anonymised personal and medical data to be used for clinical research purposes. We will publish the results in a peer-reviewed medical journal and on our institutional websites. TRIAL REGISTRATION NUMBER: NCT05385302.
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Sleep Apnea Syndromes , Sleep Apnea, Obstructive , Adult , Humans , Continuous Positive Airway Pressure , Prospective Studies , Quality of Life , Sleep Apnea, Obstructive/therapy , Ambulatory Care Facilities , Observational Studies as Topic , Multicenter Studies as TopicABSTRACT
Aim: To evaluate the evolution of glycemic outcomes in patients living with type 1 diabetes (T1D) after 1 year of use of the MiniMed 780G advanced hybrid closed-loop (AHCL) system. Methods: We conducted an observational, retrospective, multicentric study in 20 centers in France. The primary objective was to evaluate the improvement in glycemic control after 1-year use of AHCL. The primary endpoint was the variation of time in range (TIR) between pre-AHCL and after 1-year use of AHCL. Secondary objectives were to analyze the glycemic outcomes after 3, 6, and 12 months of AHCL use, the safety, and the long-term observance of AHCL. Results: Two hundred twenty patients were included, and 200 were analyzed for the primary endpoint. 92.7% of patients continued to use AHCL. After 1 year of use of AHCL, TIR was 72.5% ± 10.6% (+9.1%; 95% confidence interval [CI] [7.6-10.5] compared to pre-AHCL initiation, P < 0.001), HbA1c 7.1% ± 0.7% (-0.5%; 95% CI [-0.6 to -0.4]; P < 0.001), time below range 2.0% [1.0; 3.0] (0.0% [-2.0; 0.0], P < 0.001), and time above range 24.8% ± 10.9% (-7.3%; 95% CI [-8.8 to -5.7]; P < 0.001). More patients achieved the glycemic treatment goals of HbA1c <7.0% (45.1% vs. 18.1%, P < 0.001) and TIR >70% (59.0% vs. 29.5% P < 0.001) when compared with pre-AHCL. Five patients experienced severe hypoglycemia events and two patients experienced ketoacidosis. Conclusion: After 1 year of use of AHCL, people living with T1D safely improved their glucose control and a higher proportion of them achieved optimal glycemic control.
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Blood Glucose Self-Monitoring , Blood Glucose , Diabetes Mellitus, Type 1 , Glycemic Control , Hypoglycemic Agents , Insulin Infusion Systems , Insulin , Humans , Diabetes Mellitus, Type 1/drug therapy , Diabetes Mellitus, Type 1/blood , Retrospective Studies , Male , Female , France , Adult , Blood Glucose/analysis , Hypoglycemic Agents/therapeutic use , Hypoglycemic Agents/administration & dosage , Glycemic Control/methods , Insulin/administration & dosage , Insulin/therapeutic use , Middle Aged , Glycated Hemoglobin/analysis , Treatment Outcome , Hypoglycemia/prevention & control , Hypoglycemia/chemically inducedABSTRACT
OBJECTIVE: Variants in the FLNA gene have been associated with mitral valve dystrophy (MVD), and even polyvalvular disease has been reported. This study aimed to analyse the aortic valve and root involvement in FLNA-MVD families and its impact on outcomes. METHODS: 262 subjects (37 (18-53) years, 140 male, 79 carriers: FLNA+) from 4 FLNA-MVD families were included. Echocardiography was performed in 185 patients and histological analysis in 3 explanted aortic valves. The outcomes were defined as aortic valve surgery or all-cause mortality. RESULTS: Aortic valve alterations were found in 58% of FLNA+ compared with 6% of FLNA- (p<0.001). 9 (13.4%) FLNA+ had bicuspid aortic valve compared with 4 (3.4%) FLNA- (p=0.03). Overall, the transvalvular mean gradient was slightly increased in FLNA+ (4.8 (4.1-6.1) vs 4.0 (2.9-4.9) mm Hg, p=0.02). The sinuses of Valsalva and sinotubular junction diameters were enlarged in FLNA+ subjects (all p<0.05). 8 FLNA+ patients underwent aortic valve surgery (0 in relatives; p<0.001). Myxomatous remodelling with an infiltration of immune cells was observed. Overall survival was similar between FLNA+ versus FLNA- subjects (86±5% vs 85±6%, p=0.36). There was no statistical evidence for an interaction between genetic status and sex (p=0.15), but the survival tended to be impaired in FLNA+ men (p=0.06) whereas not in women (p=0.71). CONCLUSION: The patients with FLNA variants present frequent aortic valve disease and worse outcomes. Bicuspid aortic valve is more frequent in patients carrying the FLNA-MVD variants. These unique features should be factored into the management of patients with dystrophic and/or bicuspid aortic valve.
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Bicuspid Aortic Valve Disease , Heart Valve Diseases , Rheumatic Heart Disease , Female , Humans , Male , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Aortic Valve/pathology , Filamins/genetics , Heart Valve Diseases/diagnostic imaging , Heart Valve Diseases/genetics , Heart Valve Diseases/surgeryABSTRACT
Introduction: Trematodiases cause significant financial losses to livestock worldwide and some of which are zoonotic, raising public health concerns. In Rwanda, information on the prevalence of bovine trematodiases is scanty, and this hampers efforts to control and prevent them in the country. Methods: This cross-sectional study aimed to determine the prevalence of bovine trematodiases in Nyagatare district and associated risk factors. One hundred cattle were randomly selected for this study and faecal samples were collected directly from the rectum to identify trematode eggs using a simple sedimentation technique. To analyze the data, frequencies, chi-square test, and binary logistic regression were computed. Results: Overall, the prevalence of bovine trematodiases was 69%, and Paramphistomum spp. predominated (69%), followed by Dicrocoelium spp. (23%), Fasciola spp. (20%), and Echinostoma spp. (1.0%). The study also recorded mixed paramphistomiasis, fascioliasis and dicrocoeliasis (11.6%), paramphistomiasis and fascioliasis (15.9%) as well as paramphistomiasis and dicrocoeliasis (20.3%). The odds of having trematodiasis (mono or mixed fascioliasis and dicrocoeliasis) for the cow located in Barija cell (AOR = 0.143; 95% C.I. 0.026-0.793) were 14% lower compared to those of developing such parasitosis for the cow located in Bushoga cell. Conclusion: Taken together, the study shows that trematodes are a significant contributor to lowering livestock production and productivity and pose a threat to human health. Different approaches should be applied to prevent and control the trematodiases in cows and other livestock (sheep and goats) and reduce the risk of contracting fascioliasis and echinostomiasis in humans in Nyagatare district, Rwanda.
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Background: Laparoscopic surgery is the gold standard for many abdominal surgeries. Laparoscopic programs in low- and middle-income countries (LMICs) and in sub-Saharan Africa face many constraints, although its use is safe, feasible, and clinically beneficial. The authors assessed patient-reported outcomes and the experience of patients operated on at the University Teaching Hospital of Kigali (CHUK). Methods: This is a retrospective cross-sectional study combining medical data from medical files and information collected from telephone calls to 288 patients who underwent laparoscopic cholecystectomy at CHUK from January 2015 to December 2020. Results: Among 446 laparoscopic surgeries performed at CHUK over 6 years, cholecystectomies accounted for 64.6 % of cases (288/446). Postoperative complications and mortality after laparoscopic cholecystectomy were low, respectively 1.7 % and 0.7 %, while the median length of stay was 3 days. About 74 % of surveyed patients had never heard of laparoscopic surgery prior to their procedure. Knowledge of laparoscopic surgery was associated with patient education level (p < 0.001). Half of patients had not been involved in the choice of the surgical technique. Overall satisfaction was over 95 % and >90 % of patients consider laparoscopic surgery as the best surgical approach in Rwanda, and for this reason they declared to be ready to promote this new technology despite its higher cost. However, patients reported some weaknesses and made recommendations for improving public awareness of laparoscopy and its benefits, patient-provider relationships, training of surgical workforce, laparoscopic equipment, and infrastructure. Conclusion: Laparoscopic cholecystectomy can be performed with a low rate of postoperative complications in a resource-limited setting like Rwanda. Patient satisfaction was high, but efforts should be made to improve public awareness of laparoscopic surgery, improve surgical capacity, laparoscopic equipment, and infrastructure.
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BACKGROUND: Aortitis is a group of disorders characterized by the inflammation of the aorta. The large-vessel vasculitides are the most common causes of aortitis. Aortitis long-term outcomes are not well known. OBJECTIVES: The purpose of this study was to assess the long-term outcome and prognosis of noninfectious surgical thoracic aortitis. METHODS: This was a retrospective multicenter study of 5,666 patients with thoracic aorta surgery including 217 (3.8%) with noninfectious thoracic aortitis (118 clinically isolated aortitis, 57 giant cells arteritis, 21 Takayasu arteritis, and 21 with various systemic autoimmune disorders). Factors associated with vascular complications and a second vascular procedure were assessed by multivariable analysis. RESULTS: Indications for aortic surgery were asymptomatic aneurysm with a critical size (n = 152 [70%]), aortic dissection (n = 28 [13%]), and symptomatic aortic aneurysm (n = 30 [14%]). The 10-year cumulative incidence of vascular complication and second vascular procedure was 82.1% (95% CI: 67.6%-90.6%), and 42.6% (95% CI: 28.4%-56.1%), respectively. Aortic arch aortitis (HR: 2.08; 95% CI: 1.26-3.44; P = 0.005) was independently associated with vascular complications. Descending thoracic aortitis (HR: 2.35; 95% CI: 1.11-4.96; P = 0.031) and aortic dissection (HR: 3.08; 95% CI: 1.61-5.90; P = 0.002) were independently associated with a second vascular procedure, while treatment with statins after aortitis diagnosis (HR: 0.47; 95% CI: 0.24-0.90; P = 0.028) decreased it. After a median follow-up of 3.9 years, 19 (16.1%) clinically isolated aortitis patients developed features of a systemic inflammatory disease and 35 (16%) patients had died. CONCLUSIONS: This multicenter study shows that 82% of noninfectious surgical thoracic aortitis patients will experience a vascular complication within 10 years. We pointed out specific characteristics that identified those at highest risk for subsequent vascular complications and second vascular procedures.
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Aortic Dissection , Aortitis , Cardiovascular Diseases , Humans , Aortitis/epidemiology , Prognosis , Aorta , Inflammation , Aortic Dissection/diagnosis , Aortic Dissection/epidemiology , Aortic Dissection/surgeryABSTRACT
OBJECTIVES: We report 1-year safety and clinical outcomes in patients <60 years undergoing bioprosthetic surgical aortic valve intervention. METHODS: The INSPIRIS RESILIA Durability Registry is a prospective, multicentre registry to assess clinical outcomes of patients <60 years. Patients with planned SAVR with or without concomitant replacement of the ascending aorta and/or coronary bypass surgery were included. Time-related valve safety, haemodynamic performance and quality of life (QoL) at 1 year were assessed. RESULTS: A total of 421 patients were documented with a mean age of 53.5 years, 76.5% being male and 27.2% in NYHA class III/IV. Outcomes within 30 days included cardiovascular-related mortality (0.7%), time-related valve safety (VARC-2; 5.8%), thromboembolic events (1.7%), valve-related life-threatening bleeding (VARC-2; 4.3%) and permanent pacemaker implantation (3.8%). QoL was significantly increased at 6 months and sustained at 1 year. Freedom from all-cause mortality at 1 year was 98.3% (95% confidence interval 97.1; 99.6) and 81.8% were NYHA I versus 21.9% at baseline. No patient developed structural valve deterioration stage 3 (VARC-3). The mean aortic pressure gradient was 12.6 mmHg at 1 year and the effective orifice area was 1.9 cm2. CONCLUSIONS: The 1-year data from the INSPIRIS RESILIA valve demonstrate good safety and excellent haemodynamic performance as well as an early QoL improvement. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov: NCT03666741.
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Structural valve deterioration (SVD) of bioprosthetic heart valves (BHVs) has great clinical and economic consequences. Notably, immunity against BHVs plays a major role in SVD, especially when implanted in young and middle-aged patients. However, the complex pathogenesis of SVD remains to be fully characterized, and analyses of commercial BHVs in standardized-preclinical settings are needed for further advancement. Here, we studied the immune response to commercial BHV tissue of bovine, porcine, and equine origin after subcutaneous implantation into adult α1,3-galactosyltransferase-knockout (Gal KO) mice. The levels of serum anti-galactose α1,3-galactose (Gal) and -non-Gal IgM and IgG antibodies were determined up to 2 months post-implantation. Based on histological analyses, all BHV tissues studied triggered distinct infiltrating cellular immune responses that related to tissue degeneration. Increased anti-Gal antibody levels were found in serum after ATS 3f and Freedom/Solo implantation but not for Crown or Hancock II grafts. Overall, there were no correlations between cellular-immunity scores and post-implantation antibodies, suggesting these are independent factors differentially affecting the outcome of distinct commercial BHVs. These findings provide further insights into the understanding of SVD immunopathogenesis and highlight the need to evaluate immune responses as a confounding factor.
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The cultivation and expansion of chicken primordial germ cells (cPGCs) are of critical importance for both biotechnological applications and the management of poultry genetic biodiversity. The feeder-free culture system has become the most popular approach for the cultivation and expansion of cPGCs. However, despite some success in the cultivation of cPGCs, the reproducibility of culture conditions across different laboratories remains a challenge. This study aimed to compare two defined and enriched media for the growth of cPGCs originating from the Hubbard JA57 broiler. To this end, cPGCs were isolated from the embryonic blood of Hamburger-Hamilton (HH) stages 14-16 and cultured at various time points. The Growth properties and characteristics of these cells were evaluated in two different culture conditions (the defined or enriched medium) and their migratory properties were assessed after genetic engineering and injection into the vasculature of 2.5-day-old chicken embryos. The main finding of this study was that the use of an enriched medium (the defined medium with Knock-Out Serum Replacement; KOSR) resulted in improved growth properties of cPGCs originating from the Hubbard JA57 broiler compared to a defined medium. The ability to cultivate and expand cPGCs is crucial for the generation of both genetically engineered birds and breeds of interest from local or commercial origins. Therefore, these results highlight the importance of choosing an appropriate culture medium for cPGCs growth and expansion.
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Chickens , Germ Cells , Animals , Chick Embryo , Reproducibility of Results , Biodiversity , BiotechnologyABSTRACT
BACKGROUND: Mucociliary clearance is a cornerstone of the management of people with non-cystic fibrosis bronchiectasis (NCFB). SIMEOX, an innovative device, could facilitate autonomous airway clearance, but its use requires specific training. We hypothesised that telecare would be an effective means to train people with NCFB in the handling of device and to monitor and promote device adherence. OBJECTIVES: (1) To evaluate frequency of use of the SIMEOX for 10 weeks after telecare training. (2) To assess user satisfaction and clinical efficacy of the SIMEOX+telecare. METHODS: Multicentre, prospective, pilot study in adults with NCFB. A SIMEOX was provided to each participant at inclusion. Physiotherapists performed telecare sessions the first 2 weeks (3-5 sessions) for device training and every 10 days to reinforce motivation and provide technical support. RESULTS: 22 individuals were included, 21 analysed (38% male; mean±SD age 53±18 years; Bronchiectasis Severity Index 6.6±3.5). Fourteen participants (66.7%; 95% CI 43.1% to 84.5%) performed ≥3 SIMEOX sessions/week (self-reported adherence, primary outcome). Median (Q1; Q3) number of self-reported sessions/week for the whole group was 3.7 (1.8; 5.7). Adherence including web registration was 80.9%. At week 12, participant satisfaction rating was 9.0 (7.9; 10.0) on a 10-point visual analogue scale; respiratory function did not change but quality of life improved (COPD Assessment Test score -4.7, 95% CI -7.7 to -1.6, p=0.023; St Georges Respiratory Questionnaire -5.8, 95% CI -10.8 to -0.9, p=0.005). CONCLUSION: Adherence to and satisfaction with the SIMEOX airway clearance device supported by telecare were high in people with NCFB. The clinical efficacy needs to be confirmed in a randomised controlled trial. TRIAL REGISTRATION NUMBER: NCT04742270.
Subject(s)
Bronchiectasis , Cystic Fibrosis , Adult , Aged , Female , Humans , Male , Middle Aged , Bronchiectasis/therapy , Feasibility Studies , Pilot Projects , Prospective Studies , Quality of LifeABSTRACT
BACKGROUND: Long-term outcomes after acute type A aortic dissection (ATAAD) are related to remodelling of the descending thoracic aorta and aortic reinterventions. We compared the impact of an extensive repair at the index procedure using the Frozen Elephant Trunk (FET) technique, versus a conventional arch repair, on long-term remodelling of the descending thoracic and reintervention related to the aorta. METHODS: Consecutive patients who underwent conventional arch repair (conventional group) or FET repair (FET group) for an ATAAD from September 2018 to November 2021 were included. Patients who died before discharge or were lost to follow-up prior to the first appointment were excluded from the analysis. Preoperative and postoperative computed tomography angiography was reconstructed and diameter of the true/false lumen of the remaining aorta was compared up to 1 year. Negative (increased total diameter ≥ 5 mm) aortic remodelling was collected for each computed tomography angiography, as well as aortic reinterventions. Comparison of demographic, anatomical, and perioperative complications data were performed using Wilcoxon test for continuous variables or Chi-square test for categorical covariates. The Kaplan-Meier method estimator was used to assess survival rates. The Log rank test was used to compare survival curves between the 2 groups. RESULTS: Thirty nine patients were included, 22 in the conventional group and 17 in the FET group (82% males, mean age 60 ± 12 years). In the FET group, distal anastomosis was performed in zone 0 or 1 for 82% of patients using the simplified delivery technique. Median maximum preoperative descending aortic diameter was larger in the FET group (33 mm [30; 37] vs. 30 mm [28; 32] [P = 0.0172]). At 30 days, the rate of negative remodelling on the descending thoracic aorta was significantly higher in the conventional group (50%) than in the FET group (8%, P = 0.02). At 1 year, Kaplan-Meier analysis shown a freedom from descending aortic negative remodeling of 35.1% (95% confidence interval (CI) 18.7-66.1%) in conventional group and 44.9% (CI 95% 26.1-77.2%) in FET group with no significant difference. However, early negative remodelling was observed for the conventional group. Within a year, freedom from reintervention was observed for 74.4% (95% CI 57.1-97%) of patients in the conventional group and 75.5 (95% CI 57.1-99.7%) of patients in the FET group with no significant difference. CONCLUSIONS: Negative evolution of descending aorta remains a challenge after ATAAD. An extensive repair using the FET technique during the index procedure seems to be associated with satisfying short-term remodelling of descending aorta.