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Sacubitril-valsartan initiation in chronic heart failure patients impacts sleep apnea: the ENTRESTO-SAS study

ESC Heart Fail. 2021 Jun 8. doi: 10.1002/ehf2.13455. Online ahead of print.

ABSTRACT

AIMS: Optimizing medical cardiac treatment for sleep apnoea (SA) in patients with chronic heart failure and reduced ejection fraction (HFrEF) is an expert Grade C recommendation based on six studies encompassing a total of 67 patients only. Whether sacubitril-valsartan (SV), a cornerstone of HFrEF medical treatment, impacts SA is unknown and requires evaluation.

METHODS AND RESULTS: The ENTRESTO-SAS trial is a six-centre, prospective, open-label real-life cohort study (NCT02916160). Ambulatory patients eligible for SV (i.e. HFrEF adults who remain symptomatic despite optimal treatment) were evaluated before and after 3 months of SV (including nocturnal ventilatory polygraphy); 118 patients were final analysed [median age was 66 (IQ25-75 : 56-73) years, 81.4% male, 36.5% New York Heart Association III-IV, N-terminal pro-B-type natriuretic peptide level of 1564 (701-3376) ng/L, left ventricular ejection fraction of 30 (25-34)%, 60.7% ischaemic HFrEF, 97.5% initially treated with angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers, 83.9% with beta-blockers, 64.4% with mineralocorticoid receptor antagonists, and 74.6% with diuretics]. Three groups were defined according to initial central/obstructive apnoea-hypopnoea indices (AHIs): G1 (n = 49, AHIcentral ≥ 5/h and AHIobstructive < 15/h); G2 (n = 27, AHIobstructive ≥ 15/h); and G3 (n = 42, AHIcentral < 5/h and AHIobstructive < 15/h). At 3 months, the AHI (main predefined outcome) decreased significantly by -7.10/h (IQ25-75 : -16.10 to 0.40; P < 0.001) in G1 + G2 without positive airway pressure treatment (45 patients, median initial AHI of 24.20 (IQ25-75 : 16.40-43.50)/h). Of these, 24.4% presented an AHI decrease ≥50% and 37.78% had a final AHI < 15/h (tendency for improvement from an initial value of 20%: P = 0.0574). For G1 patients (n = 37), AHI significantly decreased from a median of 22.90 (16.00-43.50)/h to 19.20 (12.70-31.10)/h (P = 0.002). For G2 patients (n = 8), AHI decreased from a median of 30.10 (26.40-47.60)/h to 22.75 (14.60-36.90)/h (statistically non-significant, P = 0.059).

CONCLUSIONS: In this real-life population, SV treatment for 3 months in SA patients is associated with a significant decrease in AHI. These results support the current guidelines that recommend first an optimization of the HFrEF treatment in patients with HFrEF and central SA. A potential positive airway pressure sparing effect merits further investigation.

PMID:34102018 | DOI:10.1002/ehf2.13455

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Umbilical cord mesenchymal stromal cells as critical COVID-19 adjuvant therapy: A randomized controlled trial

Stem Cells Transl Med. 2021 Jun 8. doi: 10.1002/sctm.21-0046. Online ahead of print.

ABSTRACT

One of the main causes of acute respiratory distress syndrome in coronavirus disease 2019 (COVID-19) is cytokine storm, although the exact cause is still unknown. Umbilical cord mesenchymal stromal cells (UC-MSCs) influence proinflammatory T-helper 2 (Th2 ) cells to shift to an anti-inflammatory agent. To investigate efficacy of UC-MSC administration as adjuvant therapy in critically ill patients with COVID-19, we conducted a double-blind, multicentered, randomized controlled trial at four COVID-19 referral hospitals in Jakarta, Indonesia. This study included 40 randomly allocated critically ill patients with COVID-19; 20 patients received an intravenous infusion of 1 × 106 /kg body weight UC-MSCs in 100 ml saline (0.9%) solution (SS) and 20 patients received 100 ml 0.9% SS as the control group. All patients received standard therapy. The primary outcome was measured by survival rate and/or length of ventilator usage. The secondary outcome was measured by clinical and laboratory improvement, with serious adverse events. Our study showed the survival rate in the UC-MSCs group was 2.5 times higher than that in the control group (P = .047), which is 10 patients and 4 patients in the UC-MSCs and control groups, respectively. In patients with comorbidities, UC-MSC administration increased the survival rate by 4.5 times compared with controls. The length of stay in the intensive care unit and ventilator usage were not statistically significant, and no adverse events were reported. The application of infusion UC-MSCs significantly decreased interleukin 6 in the recovered patients (P = .023). Therefore, application of intravenous UC-MSCs as adjuvant treatment for critically ill patients with COVID-19 increases the survival rate by modulating the immune system toward an anti-inflammatory state.

PMID:34102020 | DOI:10.1002/sctm.21-0046

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The validity of skin conductance for assessing acute pain in mechanically ventilated infants: A cross-sectional observational study

Eur J Pain. 2021 Jun 8. doi: 10.1002/ejp.1816. Online ahead of print.

ABSTRACT

BACKGROUND: Assessing pain in mechanically ventilated infants is challenging. The assessment of skin conductance (SC) is based on the sympathetic nervous system response to stress. This study purpose was to evaluate the validity of SC for assessing pain in mechanically ventilated infants.

METHODS: A prospective cross-sectional observational design was used to study SC and its relation to: the category of procedure (i.e., painful or non-painful); the phase of procedure (i.e., before, during and after), and referent pain measurements (i.e., Premature Infant Pain Profile-Revised (PIPP-R) and Neonatal Facial Coding System (NFCS)). Eligible infants were those up to 12 months of age, in intensive care units, who were mechanically ventilated, and required painful and non-painful procedures.

RESULTS: From October 2017 to November 2018, 130 eligible infants were identified, and 55 infants were studied. SC (number of waves per second) during painful procedures (median 0.27, interquartile range 0.2-0.4) was statistically significantly higher than those during non-painful procedures (0, 0-0.09). SC during painful procedures was statistically significantly higher than those before (0, 0-0.07) and after painful procedures (0, 0-0.07). SC showed moderate statistically significant positive correlations with PIPP-R (Spearman’s rho=0.4-0.62) and the four-item NFCS (Spearman’s rho=0.31-0.67) before, during and after painful or non-painful procedures respectively. SC had excellent performance (area under the receiver operator curve=0.979) with excellent sensitivity (92.31%), specificity (95.42%) and negative predictive value (99.21%) but only sufficient positive predictive value (66.67%) when used to discriminate moderate-to-severe pain.

CONCLUSIONS: SC showed good validity for assessing pain in critically ill infants requiring mechanical ventilation.

PMID:34101941 | DOI:10.1002/ejp.1816

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The statistical risk of diagnosing coincidental acquired hemophilia A following anti-SARS-CoV-2 vaccination

J Thromb Haemost. 2021 Jun 8. doi: 10.1111/jth.15421. Online ahead of print.

ABSTRACT

We read with interest the case report by Radwi et al. of a 69 year-old man with acquired hemophilia A (AHA) following vaccination with the Pfizer-BioNTech SARS CoV-2 mRNA vaccine (1). The publication prompted us to perform a survey within the Working Party Haemostasis of the Swiss Society of Hematology to detect similar cases in Switzerland. The survey led to the identification of three cases of AHA in Switzerland between December 23rd 2020 and April 30th 2021.

PMID:34101973 | DOI:10.1111/jth.15421

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Intranasal versus sublingual route of dexmedetomidine sedation in pediatric dentistry: a randomized controlled clinical trial

Int J Paediatr Dent. 2021 Jun 8. doi: 10.1111/ipd.12848. Online ahead of print.

ABSTRACT

BACKGROUND: Most of children suffer from dental anxiety during dental treatment. Conscious sedation is used to alleviate anxiety and enhance child’s cooperation.

AIM: This study aimed to compare the efficacy of intranasal versus sublingual dexmedetomidine.

DESIGN: Forty-two healthy, uncooperative children participated in the study. They were divided randomly into two groups, group I received intranasal dexmedetomidine in the first visit and group II received sublingual dexmedetomidine, while at the second visit, the alternate route was implemented in a cross-over design. Child’s acceptance to drug administration method was assessed using four-point rating scale. Time until optimum sedation was measured. Anxiety during local anesthesia administration was scored using Venham’s rating scale. Post-operative response was recorded through Vernon et al questionnaire.

RESULTS: Sublingual route was better accepted than intranasal route, while the latter acted faster. Within groups’ comparison, no statistically significant difference in anxiety scores was found between base line and local anesthesia administration. Similarly, no significant difference in the anxiety scores was found between both groups or between genders during local anesthesia administration.

CONCLUSIONS: Both routes prevented the increase in anxiety scores equally during local anesthesia and do not have negative effect on postoperative behavior of children.

PMID:34101918 | DOI:10.1111/ipd.12848

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Dexamethasone-sparing regimens with oral NEPA for the prevention of emesis caused by high-dose cisplatin: A randomized non-inferiority study

Oncologist. 2021 Jun 7. doi: 10.1002/onco.13851. Online ahead of print.

ABSTRACT

BACKGROUND: To reduce the overall exposure to dexamethasone (DEX) in patients receiving cisplatin-based chemotherapy, we evaluated the non-inferiority of DEX on day 1, with or without low-dose DEX on days 2 and 3, combined with oral NEPA, a fixed-dose combination of netupitant and palonosetron, compared with the guideline-consistent use of 4-day DEX.

PATIENTS AND METHODS: In this open-label, multicenter study, chemo-naïve patients undergoing high-dose cisplatin (≥70 mg/m2 ), were given NEPA and DEX (12 mg) on day 1 and randomized (1:1:1 ratio) to receive either 1) no further DEX (DEX1), 2) oral DEX (4 mg daily) on days 2-3 (DEX3), or 3) DEX (4 mg twice daily) on days 2-4 (DEX4). The primary efficacy endpoint was complete response (CR: no emesis and no rescue medication) during the 5-day overall phase. The non-inferiority margin was set at -15% difference (DEX1 or DEX3 minus DEX4). Secondary efficacy endpoints included complete protection (CP: CR and none or mild nausea).

RESULTS: Two-hundred twenty-eight patients, 76 in each arm, were assessable. Non-inferiority was met for both DEX-sparing regimens and the reference arm, with overall phase CR rates of 76.3% in each of the DEX1 and DEX3 arms and 75.0% in the DEX4 arm (95% CI, -12.3% to 15% for each comparison). During the overall phase, CP rates were similar between groups.

CONCLUSIONS: A simplified regimen of NEPA plus single-dose DEX offers comparable CINV prevention throughout 5 days post-chemotherapy with the advantage of sparing patients additional doses of DEX in the high emetic risk setting of cisplatin-based chemotherapy.

IMPLICATIONS FOR PRACTICE: Dexamethasone (DEX) has traditionally played an integral role in the management of chemotherapy-induced nausea and vomiting (CINV). While generally considered safe, even short-term DEX use is associated with various side effects, and some evidence suggests that steroids may reduce the efficacy of immunotherapies and cellular therapies, if used concurrently. Our study demonstrates, for the first time, comparable antiemetic control during the 5-days post-chemotherapy with a simplified three-drug regimen of NEPA (netupitant/palonosetron) plus single-dose DEX versus the standard 4-day DEX reference treatment in patients undergoing high-dose cisplatin. This represents a clinically relevant achievement as it not only simplifies antiemetic prophylaxis but also offers an opportunity to minimize DEX-related side effects and appropriately use in patients where caution with corticosteroid use is advised.

PMID:34101934 | DOI:10.1002/onco.13851

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Remote versus early corticosteroid wean outcomes in heart transplant recipients in the contemporary era

Clin Transplant. 2021 Jun 8. doi: 10.1111/ctr.14382. Online ahead of print.

ABSTRACT

PURPOSE: The risks and benefits of remote corticosteroid weaning in heart transplant recipients more than two years post-transplant are unknown. We compared outcomes in patients undergoing early and remote steroid weaning after heart transplantation.

METHODS: We performed a retrospective study (range 09/1991- 04/2017). Primary outcomes included short-term and long-term mortality, allograft dysfunction and burden of rejection. Secondary outcomes included impact on hemoglobin A1c, lipid panel, bone scan Tscore, and body mass index.

RESULTS: 63 patients underwent corticosteroid weaning between 2012 and 2017. Outcomes of patients weaned early (n = 34; median time from transplant = 1.1 years) were compared with those weaned late (n = 29; median time from transplant = 4.4 years). 52 (82.5%) patients were successfully weaned off corticosteroids. No statistically significant difference in outcomes was found between the early and late weaning groups (p = 0.20). There were no differences in allograft function (p-value = 0.16), incidence of rejection (p = 0.46) or mortality (p = 0.15). Improvement in metabolic profile was seen in both groups but was not statistically significant.

CONCLUSIONS: In heart transplant recipients remote vs early weaning of corticosteroids is not associated with significant differences in graft function or the incidence of rejection after one-year follow-up. Moreover, there were no significant differences in survival up to three years between the two groups. This article is protected by copyright. All rights reserved.

PMID:34101911 | DOI:10.1111/ctr.14382

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Nothing About Us Without Us – Towards Genuine Inclusion of Disabled Scientists and Science Students Post Pandemic

Chemistry. 2021 Jun 8. doi: 10.1002/chem.202100268. Online ahead of print.

ABSTRACT

Scientists and students with disabilities have been severely affected by the COVID-19 pandemic, and this must be urgently addressed to avoid further entrenching existing inequalities. The need for rapid decision-making, often by senior colleagues without lived experience of disabilities, can lead to policies which discriminate against scientists with disabilities. This article reflects on disability declaration statistics and research in critical disability studies and social science to explore the challenges experienced by disabled scientists before and during the COVID-19 pandemic and highlights recommendations and examples of good practice to adopt in order to challenge ableism in STEM communities and workplaces. It is vital that disabled staff and students are fully involved in decision making. This is particularly important as we continue to respond to the challenges and opportunities associated with the ongoing COVID-19 pandemic and plan for a post-COVID-19 future. This time of great change can be used as an opportunity to listen, learn, and improve working conditions and access for scientists with disabilities, and by doing so, for everyone.

PMID:34101912 | DOI:10.1002/chem.202100268

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A Comparative Study of Kimura’s Disease and IgG4-related Disease: Similarities, Differences and Overlapping Featuress

Histopathology. 2021 Jun 8. doi: 10.1111/his.14428. Online ahead of print.

ABSTRACT

AIM: To compare the fibroinflammatory diseases Kimura’s disease (KD) and IgG4-related disease (IgG4RD) and to explore their possible relationship.

METHODS AND RESULTS: 46 cases of KD and 29 IgG4RD of our institution diagnosed from 2011 to 2020 were studied. They were compared with each other on clinical, pathological and immunohistological features. There were similar clinical features, except that IgG4RD affected older patient population, with more frequent salivary gland involvement; and KD affected head and neck lymph nodes and showed blood eosinophilia more frequently than IgG4RD. IgG4RD exhibited frequent storiform fibrosis and obliterative phlebitis while KD more frequent tissue eosinophilia, eosinophilic abscess, germinal centre eosinophilic deposit and vascularization. Twenty to 30% of KD had more than 50 IgG4+ plasma cell (PC) per high power field (HPF) and IgG4/IgG+PC ratio exceeding 40%. These parameters, however, occurred in 100% of IgG4RD. Significantly more KD had >10 IgE+PC / HPF and lymphoid germinal centre IgE reticular staining as compared to IgG4RD. All these histological and immunohistological features are overlapping in the two diseases, though differed with statistical significance.

CONCLUSION: Our study confirmed that there is significant overlap in clinical, pathological and immuohistological features between KD and IgG4RD. It is important to recognize these overlapping features and correlation with clinicopathological picture is required in differential diagnosis. The overlapping features also suggest a possible close relationship between KD and IgG4RD, which could represent different facets of a continuous fibroinflammatory disease spectrum.

PMID:34101896 | DOI:10.1111/his.14428

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Effect of electrical cardioversion on 1-year outcomes in patients with early recurrence after catheter ablation for atrial fibrillation

Clin Cardiol. 2021 Jun 8. doi: 10.1002/clc.23663. Online ahead of print.

ABSTRACT

BACKGROUND: Atrial fibrillation (AF) recurrence is common in the 3-month blanking-period after catheter ablation, during which electrical cardioversion (ECV) is usually performed to restore sinus rhythm. Whether ECV can affect the clinical outcome of post-ablation AF patients is inconsistent, however. We aimed to explore the 1-year effect of ECV on AF recurrence and rehospitalization in patients experienced recurrence within 3-month after AF catheter ablation.

METHODS: Patients who experienced recurrence within 3-month after AF catheter ablation procedure were enrolled from the China Atrial Fibrillation Registry (China-AF). A 1:3 Propensity score matching (PSM) method was applying to adjust the confounders between patients who had been treated by ECV or not. Logistic regression models were conducted to evaluate the association of ECV with 1-year AF recurrence and rehospitalization.

RESULTS: In this study, 2961 patients experienced AF recurrence within 3-month after the procedure, and 282 of them underwent successful ECV, 2155 patients did not undergo ECV. One-year AF recurrence rates were 56.4% in ECV group versus 65.4% in non-ECV group (p = .003), and were 55.9% versus 65.9%, respectively, after PSM (adjusted odds ratio [OR] 0.66; 95% confidence interval (CI): 0.49-0.88, p = .005). However, the difference of 1-year rehospitalization rates between two groups were not statistically significant before (ECV group: 23.7% vs. non-ECV group: 22.3%, p = .595) and after PSM (ECV group: 24.4% vs. non-ECV group: 21.6%, adjusted OR1.14; 95% CI 0.81-1.62, p = .451).

CONCLUSIONS: Successful ECV was associated with lower rate of one-year recurrence in patients with early recurrent AF after catheter ablation.

PMID:34101841 | DOI:10.1002/clc.23663