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BMJ Open Jun 2024Tranexamic acid (TXA) is an inexpensive and widely available medication that reduces blood loss and red blood cell (RBC) transfusion in cardiac and orthopaedic... (Randomized Controlled Trial)
Randomized Controlled Trial
INTRODUCTION
Tranexamic acid (TXA) is an inexpensive and widely available medication that reduces blood loss and red blood cell (RBC) transfusion in cardiac and orthopaedic surgeries. While the use of TXA in these surgeries is routine, its efficacy and safety in other surgeries, including oncologic surgeries, with comparable rates of transfusion are uncertain. Our primary objective is to evaluate whether a hospital-level policy implementation of routine TXA use in patients undergoing major non-cardiac surgery reduces RBC transfusion without increasing thrombotic risk.
METHODS AND ANALYSIS
A pragmatic, registry-based, blinded, cluster-crossover randomised controlled trial at 10 Canadian sites, enrolling patients undergoing non-cardiac surgeries at high risk for RBC transfusion. Sites are randomised in 4-week intervals to a hospital policy of intraoperative TXA or matching placebo. TXA is administered as 1 g at skin incision, followed by an additional 1 g prior to skin closure. Coprimary outcomes are (1) effectiveness, evaluated as the proportion of patients transfused RBCs during hospital admission and (2) safety, evaluated as the proportion of patients diagnosed with venous thromboembolism within 90 days. Secondary outcomes include: (1) transfusion: number of RBC units transfused (both at a hospital and patient level); (2) safety: in-hospital diagnoses of myocardial infarction, stroke, deep vein thrombosis or pulmonary embolism; (3) clinical: hospital length of stay, intensive care unit admission, hospital survival, 90-day survival and the number of days alive and out of hospital to day 30; and (4) compliance: the proportion of enrolled patients who receive a minimum of one dose of the study intervention.
ETHICS AND DISSEMINATION
Institutional research ethics board approval has been obtained at all sites. At the completion of the trial, a plain language summary of the results will be posted on the trial website and distributed in the lay press. Our trial results will be published in a peer-reviewed scientific journal.
TRIAL REGISTRATION NUMBER
NCT04803747.
Topics: Humans; Tranexamic Acid; Antifibrinolytic Agents; Canada; Blood Loss, Surgical; Cross-Over Studies; Erythrocyte Transfusion; Organizational Policy
PubMed: 38830735
DOI: 10.1136/bmjopen-2024-084847 -
EFORT Open Reviews Jun 2024This study sought to determine if the use of tranexamic acid (TXA) in preexisting thromboembolic risk patients undergoing total joint arthroplasty (TJA) was linked to an...
PURPOSE
This study sought to determine if the use of tranexamic acid (TXA) in preexisting thromboembolic risk patients undergoing total joint arthroplasty (TJA) was linked to an increased risk of death or postoperative complications.
METHODS
We conducted a comprehensive search for studies up to May 2023 in PubMed, Web of Science, EMBASE, and the Cochrane Library. We included randomized clinical trials, cohort studies, and case-control studies examining the use of TXA during TJA surgeries on high-risk patients. The Cochrane Risk of Bias instrument was used to gauge the excellence of RCTs, while the MINORS index was implemented to evaluate cohort studies. We used mean difference (MD) and relative risk (RR) as effect size indices for continuous and binary data, respectively, along with 95% CIs.
RESULTS
Our comprehensive study, incorporating data from 11 diverse studies involving 812 993 patients, conducted a meta-analysis demonstrating significant positive outcomes associated with TXA administration. The findings revealed substantial reductions in critical parameters, including overall blood loss (MD = -237.33; 95% CI (-425.44, -49.23)), transfusion rates (RR = 0.45; 95% CI (0.34, 0.60)), and 90-day unplanned readmission rates (RR = 0.86; 95% CI (0.76, 0.97)). Moreover, TXA administration exhibited a protective effect against adverse events, showing decreased risks of pulmonary embolism (RR = 0.73; 95% CI (0.61, 0.87)), myocardial infarction (RR = 0.47; 95% CI (0.40-0.56)), and stroke (RR = 0.73; 95% CI (0.59-0.90)). Importantly, no increased risk was observed for mortality (RR = 0.53; 95% CI (0.24, 1.13)), deep vein thrombosis (RR = 0.69; 95% CI (0.44, 1.09)), or any of the evaluated complications associated with TXA use.
CONCLUSION
The results of this study indicate that the use of TXA in TJA patients with preexisting thromboembolic risk does not exacerbate complications, including reducing mortality, deep vein thrombosis, and pulmonary embolism. Existing evidence strongly supports the potential benefits of TXA in TJA patients with thromboembolic risk, including lowering blood loss, transfusion, and readmission rates.
PubMed: 38828967
DOI: 10.1530/EOR-23-0140 -
International Journal of Cardiology Sep 2024The possibility to resheath some transcatheter heart valves (THV) facilitates the optimization of self-expandable devices implantation. However, resheating manoeuvres... (Observational Study)
Observational Study
BACKGROUND
The possibility to resheath some transcatheter heart valves (THV) facilitates the optimization of self-expandable devices implantation. However, resheating manoeuvres (expecially when repeated) increase the interaction between the transcatheter prosthesis and the patient's tissues potentially causing side-effects.
AIMS
To assess the clinical outcomes of resheathing at midterm follow-up with a focus on the safety of multiple resheathing.
METHODS
This retrospective observational study included all consecutive patients who underwent TAVI with a self-expandable supra-annular THV between December 2018 and December 2022. Primary endpoint was a composite of cardiovascular (CV) mortality, neurological events, non-fatal acute myocardial infarction and CV rehospitalizations. All clinical endpoints were assessed according to VARC-3 criteria.
RESULTS
469 TAVI procedures with self-expandable supra-annular THV were included in the study. The attempt to resheath and the resheath manoeuvres number was prospectively recorded into an electronic database. Resheating was attempted in 253 (53.9%) cases; 1, 2 and ≥ 3 resheathing were performed in respectively 122 (26.0%), 63 (13.4%) and 68 (14.5%) procedures. At a median follow-up of 640 days (interquartile range 340-1033 days), the incidence of the primary endpoint did not differ between 0 vs. ≥1 (22.7 vs. 26.1%, LogRank p = 0.584) and < 3 vs. ≥3 resheathing groups (24.2 vs. 26.5% LogRank p = 0.963). Furthermore, no significant differences in the primary endpoint were observed between 0, 1-2 and ≥ 3 resheathing (p = 0.84).
CONCLUSIONS
Our study found that resheathing of self-expandable THVs during TAVI did not result in worse clinical outcomes compared with no resheathing at mid-term follow-up. These results are independent from the number of resheathing, underling the safety of multiple resheathing in terms of peri-procedural and mid-term outcome.
CONDENSED ABSTRACT
In this retrospective observational study of 469 patients undergoing transcatheter aortic valve implantation (TAVI) for symptomatic severe aortic stenosis with self-expanding valves, we investigated the influence of resheathing on mid-term clinical outcomes. Specifically, we focused on the safety of multiple resheathing procedures. Our findings revealed no significant impact of resheathing on medium-term outcomes. The primary endpoint, a composite of cardiovascular mortality, neurological events, non-fatal acute myocardial infarction, and cardiovascular rehospitalizations, did not show statistically significant differences between no resheathing, single resheathing and multiple resheathing groups. Our study suggests that resheathing, even when performed multiple times, does not appear to significantly affect clinical outcomes at mid-term follow-up.
Topics: Humans; Transcatheter Aortic Valve Replacement; Male; Female; Retrospective Studies; Aged, 80 and over; Aged; Aortic Valve Stenosis; Prosthesis Design; Heart Valve Prosthesis; Follow-Up Studies; Treatment Outcome; Postoperative Complications
PubMed: 38815673
DOI: 10.1016/j.ijcard.2024.132218 -
International Journal of Chronic... 2024Real-life research is needed to evaluate the effectiveness of budesonide/glycopyrrolate/formoterol (BGF) in routine COPD primary care management. We assessed the... (Observational Study)
Observational Study
PURPOSE
Real-life research is needed to evaluate the effectiveness of budesonide/glycopyrrolate/formoterol (BGF) in routine COPD primary care management. We assessed the frequency of medication success among patients with COPD who initiated BGF using real-world data.
PATIENTS AND METHODS
Patients with a recorded diagnostic COPD code who started BGF with ≥2 prescriptions within 90-days were identified in the UK Optimum Patient Care Research Database and followed from first prescription until censoring at the end of follow-up (180-days), death, leaving database or end of data at 24/10/2022. The primary outcome was medication success at 90-days post-BGF initiation, defined as no major cardiac or respiratory event (ie no complicated COPD exacerbation, hospitalization for any respiratory event, myocardial infarction, new/hospitalized heart failure, and death) and no incidence of pneumonia. Medication success was also assessed at 180-days post-BGF initiation. Overall real-life medication success was claimed if the lower 95% confidence interval (CI) for the proportion of patients meeting the primary outcome was ≥70% (defined a priori).
RESULTS
Two hundred eighty-five patients were included. Prior to BGF initiation, these patients often had severe airflow obstruction (mean ppFEV: 54.5%), were highly symptomatic (mMRC ≥2: 77.9% (n = 205/263); mean CAT score: 21.7 (SD 7.8)), with evidence of short-acting β-agonist (SABA) over-use (≥3 inhalers/year: 62.1%, n=179/285), repeat OCS prescriptions (≥2 courses/year: 33.0%, n = 95/285) and multiple primary care consultations (≥2 visits/year: 61.1%, n = 174/285). Overall, 39.6% of patients (n = 113/285) switched from previous triple therapies. Real-life medication success was achieved by 96.5% of patients (n = 275/285 [95% CI: 93.6, 98.3]) during 90-days treatment with BGF and by 91.8% (n = 169/184 [95% CI: 86.9, 95.4]) of patients at 180-days. The prescribed daily dose of SABA remained stable over the study period.
CONCLUSION
The majority of patients initiating BGF experienced real-life medication success reflecting the absence of severe cardiopulmonary events. These benefits were apparent after 90-days of treatment and sustained over 180-days.
Topics: Humans; Pulmonary Disease, Chronic Obstructive; Male; Female; Aged; Primary Health Care; Treatment Outcome; Bronchodilator Agents; Middle Aged; Time Factors; Adrenergic beta-2 Receptor Agonists; United Kingdom; Glycopyrrolate; Databases, Factual; Budesonide, Formoterol Fumarate Drug Combination; Lung; Muscarinic Antagonists; Drug Combinations; Retrospective Studies; Glucocorticoids; Aged, 80 and over
PubMed: 38813078
DOI: 10.2147/COPD.S452624 -
BMC Women's Health May 2024Perioperative urinary tract infections (PUTIs) are common in the United States and are a significant contributor to high healthcare costs. There is a lack of large...
INTRODUCTION
Perioperative urinary tract infections (PUTIs) are common in the United States and are a significant contributor to high healthcare costs. There is a lack of large studies on the risk factors for PUTIs after total hysterectomy (TH).
METHODS
We conducted a retrospective study using a national inpatient sample (NIS) of 445,380 patients from 2010 to 2019 to analyze the risk factors and annual incidence of PUTIs associated with TH perioperatively.
RESULTS
PUTIs were found in 9087 patients overall, showing a 2.0% incidence. There were substantial differences in the incidence of PUTIs based on age group (P < 0.001). Between the two groups, there was consistently a significant difference in the type of insurance, hospital location, hospital bed size, and hospital type (P < 0.001). Patients with PUTIs exhibited a significantly higher number of comorbidities (P < 0.001). Unsurprisingly, patients with PUTIs had a longer median length of stay (5 days vs. 2 days; P < 0.001) and a higher in-hospital death rate (from 0.1 to 1.1%; P < 0.001). Thus, the overall hospitalization expenditures increased by $27,500 in the median ($60,426 vs. $32,926, P < 0.001) as PUTIs increased medical costs. Elective hospitalizations are less common in patients with PUTIs (66.8% vs. 87.6%; P < 0.001). According to multivariate logistic regression study, the following were risk variables for PUTIs following TH: over 45 years old; number of comorbidities (≥ 1); bed size of hospital (medium, large); teaching hospital; region of hospital(south, west); preoperative comorbidities (alcohol abuse, deficiency anemia, chronic blood loss anemia, congestive heart failure, diabetes, drug abuse, hypertension, hypothyroidism, lymphoma, fluid and electrolyte disorders, metastatic cancer, other neurological disorders, paralysis, peripheral vascular disorders, psychoses, pulmonary circulation disorders, renal failure, solid tumor without metastasis, valvular disease, weight loss); and complications (sepsis, acute myocardial infarction, deep vein thrombosis, gastrointestinal hemorrhage, pneumonia, stroke, wound infection, wound rupture, hemorrhage, pulmonary embolism, blood transfusion, postoperative delirium).
CONCLUSIONS
The findings suggest that identifying these risk factors can lead to improved preventive strategies and management of PUTIs in TH patients. Counseling should be done prior to surgery to reduce the incidence of PUTIs.
THE MANUSCRIPT ADDS TO CURRENT KNOWLEDGE
In medical practice, the identification of risk factors can lead to improved patient prevention and treatment strategies. We conducted a retrospective study using a national inpatient sample (NIS) of 445,380 patients from 2010 to 2019 to analyze the risk factors and annual incidence of PUTIs associated with TH perioperatively. PUTIs were found in 9087 patients overall, showing a 2.0% incidence. We found that noted increased length of hospital stay, medical cost, number of pre-existing comorbidities, size of the hospital, teaching hospitals, and region to also a play a role in the risk of UTI's.
CLINICAL TOPICS
Urogynecology.
Topics: Humans; Female; Retrospective Studies; Urinary Tract Infections; Hysterectomy; Risk Factors; Middle Aged; Incidence; Adult; Postoperative Complications; United States; Aged; Length of Stay; Perioperative Period
PubMed: 38811924
DOI: 10.1186/s12905-024-03153-5 -
Frontiers in Public Health 2024To evaluate the extent to which patient-users reporting symptoms of five severe/acute conditions requiring emergency care to an AI-based virtual triage (VT) engine had...
OBJECTIVE
To evaluate the extent to which patient-users reporting symptoms of five severe/acute conditions requiring emergency care to an AI-based virtual triage (VT) engine had no intention to get such care, and whose acuity perception was misaligned or decoupled from actual risk of life-threatening symptoms.
METHODS
A dataset of 3,022,882 VT interviews conducted over 16 months was evaluated to quantify and describe patient-users reporting symptoms of five potentially life-threatening conditions whose pre-triage healthcare intention was other than seeking urgent care, including myocardial infarction, stroke, asthma exacerbation, pneumonia, and pulmonary embolism.
RESULTS
Healthcare intent data was obtained for 12,101 VT patient-user interviews. Across all five conditions a weighted mean of 38.5% of individuals whose VT indicated a condition requiring emergency care had no pre-triage intent to consult a physician. Furthermore, 61.5% intending to possibly consult a physician had no intent to seek emergency medical care. After adjustment for 13% VT safety over-triage/referral to ED, a weighted mean of 33.5% of patient-users had no intent to seek professional care, and 53.5% had no intent to seek emergency care.
CONCLUSION
AI-based VT may offer a vehicle for early detection and care acuity alignment of severe evolving pathology by engaging patients who believe their symptoms are not serious, and for accelerating care referral and delivery for life-threatening conditions where patient misunderstanding of risk, or indecision, causes care delay. A next step will be clinical confirmation that when decoupling of patient care intent from emergent care need occurs, VT can influence patient behavior to accelerate care engagement and/or emergency care dispatch and treatment to improve clinical outcomes.
Topics: Humans; Triage; Female; Male; Referral and Consultation; Middle Aged; Adult; Early Diagnosis; Patient Acuity; Emergency Service, Hospital; Aged; Emergency Medical Services; Patient Acceptance of Health Care
PubMed: 38807993
DOI: 10.3389/fpubh.2024.1362246 -
Thrombosis Research Jul 2024Hughes-Stovin syndrome (HSS) is a rare systemic vasculitis with widespread venous/arterial thrombosis and pulmonary vasculitis. Distinguishing between pulmonary embolism...
Pulmonary embolism versus pulmonary vasculitis in Hughes-Stovin syndrome: Characteristic computed tomography pulmonary angiographic findings and diagnostic and therapeutic implications. HSS International Study Group.
BACKGROUND AND AIM
Hughes-Stovin syndrome (HSS) is a rare systemic vasculitis with widespread venous/arterial thrombosis and pulmonary vasculitis. Distinguishing between pulmonary embolism (PE) and in-situ thrombosis in the early stages of HSS is challenging. The aim of the study is to compare clinical, laboratory, and computed tomography pulmonary angiography (CTPA) characteristics in patients diagnosed with PE versus those with HSS.
METHODS
This retrospective study included 40 HSS patients with complete CTPA studies available, previously published by the HSS study group, and 50 patients diagnosed with PE from a single center. Demographics, clinical and laboratory findings, vascular thrombotic events, were compared between both groups. The CTPA findings were reviewed, with emphasis on the distribution, adherence to the mural wall, pulmonary infarction, ground glass opacification, and intra-alveolar hemorrhage. Pulmonary artery aneurysms (PAAs) in HSS were assessed and classified.
RESULTS
The mean age of HSS patients was 35 ± 12.3 years, in PE 58.4 ± 17 (p < 0.0001). Among PE 39(78 %) had co-morbidities, among HSS none. In contrast to PE, in HSS both major venous and arterial thrombotic events are seen.. Various patterns of PAAs were observed in the HSS group, which were entirely absent in PE. Parenchymal hemorrhage was also more frequent in HSS compared to PE (P < 0.001).
CONCLUSION
Major vascular thrombosis with arterial aneurysms formation are characteristic of HSS. PE typically appear loosely-adherent and mobile whereas "in-situ thrombosis" seen in HSS is tightly-adherent to the mural wall. Mural wall enhancement and PAAs are distinctive pulmonary findings in HSS. The latter findings have significant therapeutic ramifications.
Topics: Humans; Pulmonary Embolism; Female; Male; Adult; Middle Aged; Retrospective Studies; Computed Tomography Angiography; Vasculitis; Aged; Pulmonary Artery
PubMed: 38795561
DOI: 10.1016/j.thromres.2024.109040 -
Journal of Clinical Medicine May 2024: The newly emergent COVID-19 pandemic involved primarily the respiratory system and had also major cardiovascular system (CVS) implications, revealed by acute... (Review)
Review
: The newly emergent COVID-19 pandemic involved primarily the respiratory system and had also major cardiovascular system (CVS) implications, revealed by acute myocardial infarction (AMI), arrhythmias, myocardial injury, and thromboembolism. CVS involvement is done through main mechanisms-direct and indirect heart muscle injury, with high mortality rates, worse short-term outcomes, and severe complications. AMI is the echo of myocardial injury (revealed by increases in CK, CK-MB, and troponin serum markers-which are taken into consideration as possible COVID-19 risk stratification markers). When studying myocardial injury, physicians can make use of imaging studies, such as cardiac MRI, transthoracic (or transesophageal) echocardiography, coronary angiography, cardiac computed tomography, and nuclear imaging (which have been used in cases where angiography was not possible), or even endomyocardial biopsy (which is not always available or feasible). We present the cases of two COVID-19 positive male patients who were admitted into the Clinical Department of Cardiology in "Sfântul Apostol Andrei" Emergency Clinical Hospital of Galați (Romania), who presented with acute cardiac distress symptoms and have been diagnosed with ST elevation AMI. The patients were 82 and 57 years old, respectively, with moderate and severe forms of COVID-19, and were diagnosed with anteroseptal left ventricular AMI and extensive anterior transmural left ventricular AMI (with ventricular fibrillation at presentation), respectively. The first patient was a non-smoker and non-drinker with no associated comorbidities, and was later discharged, while the second one died due to AMI complications. From this two-case series, we extract the following: old age alone is not a significant risk factor for adverse outcomes in COVID-19-related CVS events, and that the cumulative effects of several patient-associated risk factors (be it either for severe forms of COVID-19 and/or acute cardiac injury) will most probably lead to poor patient prognosis (death). At the same time, serum cardiac enzymes, dynamic ECG changes, along with newly developed echocardiographic modifications are indicators for poor prognosis in acute cardiac injury in COVID-19 patients with acute myocardial injury, regardless of the presence of right ventricular dysfunction (due to pulmonary hypertension).
PubMed: 38792477
DOI: 10.3390/jcm13102936 -
Journal of Clinical Medicine May 2024Obesity or overweight raises the risk of developing 13 types of cancer, representing 40% of all cancers diagnosed in the United States annually. Given the ongoing...
Rising Trends in Metabolically Healthy Obesity in Cancer Patients and Its Impact on Cardiovascular Events: Insights from a Contemporary Nationwide Analysis in the USA (2016-2020).
Obesity or overweight raises the risk of developing 13 types of cancer, representing 40% of all cancers diagnosed in the United States annually. Given the ongoing debate surrounding the impact of metabolically healthy obesity (MHO) on cardiovascular outcomes, it is crucial to comprehend the incidence of Major Adverse Cardiovascular and Cerebrovascular Events (MACCEs) and the influence of MHO on these outcomes in cancer patients. Data of hospitalized cancer patients with and without obesity were analyzed from the National Inpatient Sample 2016-2020. Metabolically healthy patients were identified by excluding diabetes, hypertension, and hyperlipidemia using Elixhauser comorbidity software, v.2022.1. After that, we performed a multivariable regression analysis for in-hospital MACCEs and other individual outcomes. We identified 3,111,824 cancer-related hospitalizations between 2016 and 2020. The MHO cohort had 199,580 patients (6.4%), whereas the MHnO (metabolically healthy non-obese) cohort had 2,912,244 patients (93.6%). The MHO cohort had a higher proportion of females, Blacks, and Hispanics. Outcomes including in-hospital MACCEs (7.9% vs. 9.5%; < 0.001), all-cause mortality (6.1% vs. 7.5%; < 0.001), and acute myocardial infarction (AMI) (1.5% vs. 1.6%; < 0.001) were lower in the MHO cohort compared to the MHnO cohort. Upon adjusting for the baseline characteristics, the MHO group had lower odds of in-hospital MACCEs [adjusted odds ratio (AOR) = 0.93, 95% CI (0.90-0.97), < 0.001], all-cause mortality [AOR = 0.91, 95% CI (0.87-0.94); < 0.001], and acute ischemic stroke (AIS) [AOR = 0.76, 95% CI (0.69-0.84); < 0.001], whereas there were higher odds of acute myocardial infarction (AMI) [AOR = 1.08, 95% CI (1.01-1.16); < 0.001] and cardiac arrest (CA) [AOR = 1.26, 95% CI (1.01-1.57); = 0.045] in the MHO cohort compared to the MHnO cohort. Hospitalized cancer patients with MHO exhibited a lower prevalence of in-hospital MACCEs than those with MHnO. Additional prospective studies and randomized clinical trials are imperative to validate these findings, particularly in stratifying MHO across various cancer types and their corresponding risks of in-hospital MACCEs.
PubMed: 38792362
DOI: 10.3390/jcm13102820 -
Journal of Clinical Medicine May 2024Ischemic stroke is the second, and pulmonary embolism (PE) is the third most common cardiovascular cause of death after myocardial infarction. Data regarding risk...
Ischemic stroke is the second, and pulmonary embolism (PE) is the third most common cardiovascular cause of death after myocardial infarction. Data regarding risk factors for ischemic stroke in patients with acute PE are limited. Patients were selected by screening the German nationwide in-patient sample for PE (ICD-code I26) and were stratified by ischemic stroke (ICD code I63) and compared. The nationwide in-patient sample comprised 346,586 hospitalized PE patients (53.3% females) in Germany from 2011 to 2014; among these, 6704 (1.9%) patients had additionally an ischemic stroke. PE patients with ischemic stroke had a higher in-hospital mortality rate than those without (28.9% vs. 14.5%, < 0.001). Ischemic stroke was independently associated with in-hospital death (OR 2.424, 95%CI 2.278-2.579, < 0.001). Deep venous thrombosis and/or thrombophlebitis (DVT) combined with heart septal defect (OR 24.714 [95%CI 20.693-29.517], < 0.001) as well as atrial fibrillation/flutter (OR 2.060 [95%CI 1.943-2.183], < 0.001) were independent risk factors for stroke in PE patients. Systemic thrombolysis was associated with a better survival in PE patients with ischemic thrombolysis who underwent cardio-pulmonary resuscitation (CPR, OR 0.55 [95%CI 0.36-0.84], = 0.006). Ischemic stroke did negatively affect the survival of PE. Combination of DVT and heart septal defect and atrial fibrillation/flutter were strong and independent risk factors for ischemic stroke in PE patients. In PE patients with ischemic stroke, who had to underwent CPR, systemic thrombolysis was associated with improved survival.
PubMed: 38792272
DOI: 10.3390/jcm13102730