Single-center Pilot Research Articles

Distal Upper Extremity Arterial Calcification as a Predictor for Subclinical Coronary Artery Disease by Coronary Artery Calcium Scoring.

Several studies have linked calcification of the thoracic and lower extremity arterial trunks to an increased risk of developing coronary artery disease (CAD). Calcifications of the radial and/or ulnar artery are regularly identified in hand/wrist x-rays; however, the clinical relevance of these findings as related to identifying subclinical CAD is not well understood. Associations between CAD and upper extremity calcifications have been reported, but the timeline is unclear. The purpose of this study was to evaluate the association between upper extremity arterial calcifications on hand radiographs with CAD by coronary artery calcification (CAC) scoring in patients with no known history of CAD. This is a pilot single-center, prospective, matched cohort study. We included patients with no known history of CAD, related symptoms, or major risk factors. We recruited five patients with calcifications (cal+) and five patients matched by age, race, sex, and medical history but without calcifications (cal-). CAC scores were determined from computed tomography scanning, and lipid profile was evaluated. In the cal+ group, the mean CAC total score was 244.1; in the control (cal-) group, it was 85.2. The mean total cholesterol levels were 220.8 mg per dL and 167 mg per dL in the cal+ and cal- groups, respectively. Two cal+ patients with CAC scores of 937 and 669 died shortly after being enrolled in our study. Preliminary findings suggest that calcifications in the radial or ulnar artery in otherwise asymptomatic patients with no history of CAD may be an independent sign of CAD.

Potential for expanded application of endoscopic hand suturing: A pilot study of 15 cases.

Endoscopic hand suturing (EHS) was first developed to firmly close a mucosal defect following endoscopic submucosal dissection and has the potential for expanded applications. This study aimed to investigate the feasibility and safety of EHS in various clinical settings. In this single-center pilot study, 15 patients who had diseases with potential indications for EHS were prospectively recruited. Technical success, clinical success after the procedure, and severe EHS-related adverse events (AEs) were evaluated. EHS was applied for defect closure after gastric subepithelial lesion removal under laparoscopic observation (n = 9), defect closure after rectal endoscopic full-thickness resection (EFTR) (n = 2), defect closure after thoracoscopy-assisted esophageal EFTR (n = 1), mucosal closure for gastric ulcer bleeding (n = 1), mucosal closure after peroral endoscopic myotomy (POEM) (n = 1), and postoperative anastomotic leak (n = 1). EHS was completed without severe AEs and the clinical courses were also favorable in 13 patients (87%). The median suturing time was 61 minutes. In patients with POEM and anastomotic leak, EHS was discontinued because of the narrow lumen. In conclusion, EHS appears feasible and safe in situations.

Optimal Prone Position Duration in Patients With ARDS Due to COVID-19: The Omelette Pilot Trial.

Prone position (PP) has been widely used in the COVID-19 pandemic for ARDS management. However, the optimal length of a PP session is still controversial. This study aimed to evaluate the effects of prolonged versus standard PP duration in subjects with ARDS due to COVID-19. This was a single-center, randomized controlled, parallel, and open pilot trial including adult subjects diagnosed with severe ARDS due to COVID-19 receiving invasive mechanical ventilation that met criteria for PP between March-September 2021. Subjects were randomized to the intervention group of prolonged PP (48 h) versus the standard of care PP (∼16 h). The primary outcome variable for the trial was ventilator-free days (VFDs) to day 28. We enrolled 60 subjects. VFDs were not significantly different in the standard PP group (18 [interquartile range [IQR] 0-23] VFDs vs 7.5 [IQR 0-19.0] VFDs; difference, -10.5 (95% CI -3.5 to 19.0, P = .08). Prolonged PP was associated with longer time to successful extubation in survivors (13.00 [IQR 8.75-26.00] d vs 8.00 [IQR 5.00-10.25] d; difference, 5 [95% CI 0-15], P = .001). Prolonged PP was also significantly associated with longer ICU stay (18.5 [IQR 11.8-25.3] d vs 11.50 [IQR 7.75-25.00] d, P = .050) and extended administration of neuromuscular blockers (12.50 [IQR 5.75-20.00] d vs 5.0 [IQR 2.0-14.5] d, P = .005). Prolonged PP was associated with significant muscular impairment according to lower Medical Research Council values (59.6 [IQR 59.1-60.0] vs 56.5 [IQR 54.1-58.9], P = .02). Among subjects with severe ARDS due to COVID-19, there was no difference in 28-d VFDs between prolonged and standard PP strategy. However, prolonged PP was associated with a longer ICU stay, increased use of neuromuscular blockers, and greater muscular impairment. This suggests that prolonged PP is not superior to the current recommended standard of care.

UCOMB-real life data: treatment strategies for chronic urticaria patients with comorbidities

Background There is a lack of real-life safety data on treatment options for chronic urticaria in the presence of comedication and comorbidities. Methods We present a single-center UCARE pilot study of 212 outpatients with chronic urticaria. Patients were divided into three groups according to different CU therapies according to international guidelines. Results Of 212 patients, 108 (mean age 48.9 years, 71.3% female) had 59 comorbidities, including cardiovascular, autoimmune and malignant diseases. Patients were followed for a mean of 24.6 months (SD ± 21.3). Urticaria therapies were divided into three groups: A: 105 (97.2%) with omalizumab and 2nd generation antihistamines), B: 16 patients (14.8%): dual therapy with antihistamines and cyclosporine in 10 (9.3%), montelukast in five (4. 6%), dapsone in four (3.7%), hydroxychloroquine in one patient (0.9%), C: 12 (11.1%) patients received a third drug for 4.9 months (SD ± 3.2) and one quadruple therapy (2.1 months). 10 out of 12 (83.3%) patients received montelukast, two (16.7%) cyclosporine, two (16.7%) dapsone and one (8.3%) hydroxychloroquine as a third drug for chronic urticaria. Conclusions Combining treatment modalities for chronic urticaria and comorbidities are available and feasible with a good safety profile.

A study of safety and effectiveness of amino-acids based multi-nutrient fortifier in preterm infants

Background: Fortification plays a vital role in supporting the nutritional requirements in the premature infants. Currently in India, fortifiers are either whole protein based or whey protein which are bovine milk- based, which has been associated with increased risk of feed intolerance and necrotizing enterocolitis (NEC), to circumvent this, an amino-acids based fortifier has been made available which provides more proteins (0.35 g/1 g sachet) thereby meeting the nutritional requirements of preterm infants. Aim was to study effect (safety and efficacy) of fortification with the amino-acids based fortifier (HMF-ADVANCE, Analeptik Biologicals) in premature infants admitted in the neonatal intensive care unit (NICU). Methods: A single centre pilot study was conducted on preterm infants with <1800 g birth weight and/or <32 gestational age, amino-acids based fortifier (AABF) was used as the fortification option once the infants reached 100 ml/kg/day feed volume. 1 g of HMF-ADVANCE was mixed in 25 ml of mother’s own milk (MOM) and the fortification was continued till discharge from NICU. Results: A total 100 preterm infants were included for the study, mean gestational age (GA) was 29.38±1.61 weeks, mean birth weight was 1159.90±301.9. Growth outcomes at the end of the study: mean weight gain was 23.73±7.62 g/day, mean head circumference gain was 1.02±0.41 cm/week, mean length gain was 1.01±0.15 cm/week and weight gain velocity were 17.13±2.38 g/kg/day. Blood urea nitrogen (BUN) showed an increasing trend from baseline (before starting fortification: 3.2 mg/dl), 1 week after fortification (6.3 mg/dl) and at the end of study (11.2 mg/dl). AABF was also used in three neonates post NEC. There were no episodes of feed intolerance or necrotising enterocolitis episodes and none of neonates discontinued fortification till discharge from NICU. Conclusions: AABF was well tolerated without any feed intolerance episodes and helped to achieve optimal growth. AABF can be the optimal choice of fortification in low-birth-weight neonates.

Hemodynamic performance of self-expandable transcatheter aortic valve replacement systems during valve deployment.

Little is known about valve hemodynamic performance during the Evolut and Neo deployment course. We aimed to evaluate transvalvular mean and peak-to-peak gradients over several intraprocedural timepoints during TAVR with Evolut PRO+ (Medtronic) and Neo (Boston Scientific) systems. This was single-center pilot sub-study from the SavvyWire EFficacy and SafEty in Transcatheter Aortic Valve Implantation Procedures (SAFE-TAVI) trial. Participants received either the Evolut PRO+ or Neo for native valve severe aortic stenosis and the SavvyWire (OpSens Medical) was used for device delivery, pacing, and continuous left ventricular and aortic pressure measurements. For the Evolut, evaluation was done for baseline, two-thirds of valve deployment (still recapturable), 90% of valve deployment (no longer recapturable), and post-deployment hemodynamics. For the Neo, analysis was done at baseline, after the first step (top-crown deployment), and at final status. Nineteen patients were included (Evolut = 15; Neo = 4). There were no statistically significant changes in peak-to-peak gradients (44 mm Hg [IQR:33-69] vs 43 mm Hg [IQR:26-62], P = .41) between baseline and two-thirds of valve deployment in the Evolut patients. There was a significant decrease in mean (40 mm Hg [IQR:32-54] vs 14 mm Hg [IQR:10-18], P less than .001) and peak-to-peak (43 mmHg [IQRS:26-62] vs 9 mm Hg [IQR:8-13], P less than .001) transvalvular gradients between two-thirds and 90% of valve deployment for Evolut. Neo patients exhibited a decrease in transvalvular gradients after top-crown deployment (42.5 mm Hg baseline vs 13 mm Hg). Transvalvular gradients did not vary between the point of "no-recapture" compared to baseline values in patients receiving the Evolut, whereas a significant reduction in transvalvular gradients was observed when the valve was deployed at 90% and fully deployed. The Neo valve was slightly obstructive after the first step of deployment.

Virtual Follow-Up in Patients Initiating Antineoplastic Treatment in the Ambulatory Setting.

Initiating antineoplastic therapy can be distressful and affect patient retention of treatment-related side effects and safety protocols. Return visits can range from 8 to 28 days after treatment, during which patients may develop treatment-related questions and toxicities. This study's objective is to evaluate how implementing a follow-up phone call 24-48 hours after initial antineoplastic infusion, compared with standard pretreatment education, affects patient satisfaction and education retention. We conducted a single-center pilot study where patients who were literate, English-speaking, with genitourinary malignancies, initiating intravenous chemotherapy or immunotherapy were eligible. The primary end point was patient knowledge retention. Secondary end points included patient satisfaction. The Leuven's Questionnaire Patient Knowledge Tool, a validated, standardized tool, was used to evaluate patient knowledge retention, with a higher score indicating more retention. Telephone follow-up was initiated 24-48 hours after initial infusion, where Leuven's Questionnaire was used to assess patient knowledge. A nurse then reinforced treatment-related education, reviewed notification parameters, and coordinated appropriate follow-up. One week later, participants were sent a follow-up Leuven's Questionnaire and standardized patient satisfaction assessment. Thirty-one patients with renal cell carcinoma, prostate, bladder, germ cell/testicular, or adrenal cancers were included in the study. Mean preintervention Leuven's Questionnaire score was 5.3 and mean postintervention score was 8.1 on a 1-10 scale (P < .0001). Ninety-seven percent of patients reported improved satisfaction postintervention. Proactive telephonic follow-up for oncology patients improves education retention, patient satisfaction, and has potential to improve patient safety and quality of care.

Efficacy of surgical staple line reinforcement in Glissonean stapling: A single-center pilot study.

Vascular staplers are routinely used in laparoscopic liver resection, which has become a standard procedure in advanced medical facilities. Although previous reports have outlined the benefits of staple line reinforcement (SLR), its application in Glissonean pedicle transection during hepatic resection remains poorly studied. This study investigated surgical SLR as a tool to enhance staple line strength and improve perioperative hemostasis. Here, 10 patients who underwent laparoscopic liver resection using the Tri-StapleTM2.0 Reinforced Reload were included. Patient characteristics, surgical details, and outcomes were assessed. The results demonstrated successful outcomes with no complications related to bile leakage or injuries during staple insertion. Overall, our findings suggest that SLR can be safely utilized in Glissonean pedicle transection during laparoscopic liver resections. Further studies are required to comprehensively evaluate its benefits compared with conventional surgical staplers.

Neck muscle spasticity in patients with disorder of consciousness: a pilot study.

Disorder of consciousness (DOC) is a state of prolonged altered consciousness due to severe acquired brain injury (ABI). DOC can be differentiated into coma, unresponsive wakefulness syndrome (UWS), or minimally conscious state (MCS) depending on the behavioral features observed and their relationship to the level of consciousness. Spasticity is one of the most frequently reported medical comorbidities in DOC patients. Since there is a critical lack of spasticity-focused studies and, in turn, of target treatment, we designed this pilot prospective study to evaluate cervical spine muscle spasticity and its effect on rehabilitation outcome in a large cohort of patients followed from the post-acute phase to 6 months after severe ABI. To evaluate neck muscle spasticity and investigate its impact on neurological and functional outcome in a large cohort of adult patients with DOC followed from post-acute to 6 months after severe ABI. Single-center prospective pilot study. Highly specialized inpatient neurorehabilitation clinic. Patients with severe ABI admitted within 3 months after the acute event to our Neurorehabilitation Unit between May 21st, 2019 and April 23rd, 2020 for treatment of DOC as a part of their rehabilitation program. In this single-center prospective pilot study demographic data, etiology of ABI (traumatic versus non-traumatic), DOC evaluated with the revised Coma Recovery Scale (CRS-R), and neurological and functional outcome assessed respectively with the Glasgow Coma Scale (GCS) and Functional Independence Measure (FIM) were considered. During cervical examination, we assessed spasticity with the Modified Ashworth Scale (MAS), deviation of head alignment with a goniometer, and pain with the Nociception Coma Scale-Revised (NCS-R). Of the 48 patients, 41.7% were diagnosed with UWS and 58.3% were in a minimally conscious state (MCS). We found spasticity of neck muscles in 91.7% of patients, with no difference in severity (assessed with MAS) between UWV and MCS. The NCS-R score at cervical spine examination was lower in UWS than MCS. Spasticity was severer in patients with traumatic brain injury (TBI) compared to non-traumatic. At multiple linear regression analysis, younger age, hemisyndrome, and tetraparesis were independent predictors of severity of neck muscle spasticity in MCS. More severe spasticity was a predictor of worse neurological and functional outcome at discharge in UWS patients, independently of the other confounding variables at admission (e.g., age, severity of brain injury, functional assessment, and pain). Spasticity of neck muscles frequently develops in patients with DOC and is more severe in those after TBI. UWV and MCS have different spasticity profiles as regards risk factors and neurological and functional outcome. Severity of neck muscle spasticity in UWV patients may represent an early indicator of worse neurological and functional outcome after inpatient rehabilitation. Our findings could prompt clinicians to redefine the rehabilitation aims regarding spasticity and to estimate the functional outcome in patients undergoing intensive rehabilitation after severe ABI.

Stroke Education for Obstetric Providers: A Single-Center Pilot Following a Case of Delayed Recognition of Postpartum Intracerebral Hemorrhage

Stroke Education for Obstetric Providers: A Single-Center Pilot Following a Case of Delayed Recognition of Postpartum Intracerebral Hemorrhage

Trauma Patient-Centered Discharge Plan Form: A Pilot Study.

Comprehensive and multidisciplinary discharge planning can improve trauma patient throughput, decrease length of hospitalization, increase family and patient support, and expedite hospital discharge. This study aimed to assess the feasibility and acceptability of implementing a patient-centered discharge plan form for adult trauma patients. A single-center pilot study was conducted with adult trauma patients on a neurosurgical medical-surgical floor at a Level II trauma center in the Western United States from January to February 2023. The study had three phases: observation, pilot intervention, and follow-up. The key pilot intervention was the development of a standardized patient-centered discharge plan form, pilot tested by a trauma advanced practice provider and an inpatient discharge nurse. The primary outcome was the frequency of discharge orders being written before noon on the day of discharge. Qualitative and quantitative outcomes are reported. The discharge form was used for eight patients during the pilot intervention phase; an advanced practice provider and an inpatient discharge nurse each completed the forms for four patients. Five of eight observed patients had discharge orders before noon; the incidence of orders before noon was slightly higher when the form was completed by the discharge nurse (three of four patients) than by the advanced practice provider (two of four patients). The pilot study found that the patient-centered discharge plan form was feasible and acceptable to help improve the discharge process for trauma patients. Additional work to further refine the form's content and administration is warranted.

Retrograde balloon pull-through technique for benign esophageal strictures: a single-center pilot experience

Retrograde balloon pull-through technique for benign esophageal strictures: a single-center pilot experience

In vivo measurement of pediatric extracorporeal oxygenator insensible losses; a single center pilot study.

Fluid overload on Extracorporeal Membrane Oxygenation (ECMO) is associated with worse outcomes. Previous in vitro studies have attempted to quantify oxygenator-related insensible losses, as failure to account for this fluid loss may lead to inaccurate fluid balance assessment and potentially harmful clinical management, such as unnecessary exposure to diuretics, slow continuous ultrafiltration (SCUF), or continuous kidney replacement therapy (CKRT). We performed a novel in vivo study to measure insensible fluid losses in pediatric ECMO patients. Pediatric ECMO patients were approached over eleven months in the pediatric and cardiac intensive care units. The water content of the oxygenator inflow sweep gas and exhaust gas were calculated by measuring the ambient temperature and relative humidity at frequent intervals and various sweep flow. Nine subjects were enrolled, generating 431 data points. The cohort had a median age of 11 years IQR [0.83, 13], weight of 23.2 kg IQR [6.48, 44.28], and body surface area of 0.815 m2 IQR [0.315, 1.3725]. Overall, the cohort had a median sweep of 2.5 L/min [0.9, 4], ECMO flow of 3.975 L/m2/min [0.75, 4.51], and a set ECMO temperature of 37 degrees Celsius [36.6, 37.2]. The calculated net water loss per L/min of sweep was 75.93 ml/day, regardless of oxygenator size or patient weight. There was a significant difference in median documented vs. calculated fluid balance incorporating the insensible fluid loss, irrespective of oxygenator size (pediatric oxygenator: 7.001 ml/kg/day [-12.37, 28.59] vs. -6.11 ml/kg/day [-17.44, 13.01], respectively, p = 0.005 and adult oxygenator: 14.36 ml/kg/day [1.54, 25.77] and 9.204 ml/kg/day [-1.28, 22.05], respectively, p = <0.001). We present this pilot study of measured oxygenator-associated insensible fluid losses on ECMO. Our results are consistent with prior in vitro methods and provide the basis for future studies evaluating the impact of incorporating these fluid losses into patients' daily fluid balance on patient management and outcomes.

A community-based advanced nurse practitioner-led integrated oncology care model for adults receiving oral anticancer medication: a pilot study

Oral anti-cancer medications (OAMs) are being used increasingly within cancer care. OAMs offer the potential to improve patient convenience and increase hospital capacity. The clinical assessment for each cycle of OAMs requires specialist patient review often performed in hospital-based oncology units. Consequently, any potential improvement in patient expediency or increased hospital capacity that OAMs can offer is not realised. This study aimed to develop and pilot the specialist assessment of patients receiving OAMs by an Advanced Nurse Practitioner (ANP) in a community-based location.The primary aim of this pilot study was to assess the feasibility of a community-based ANP-led integrated oncology care model for adults receiving OAMs in Ireland who met the pre-specified eligibility criteria. The objectives were to determine the feasibility of a definitive trial of this intervention by measuring patient safety, acceptability to patients and staff and cost of the new model of care.This single-centre pilot study provided patient care (n = 37) to those receiving OAM therapies within a community setting for a 4-month period. Consent rate was high with no attrition other than for clinical reasons. There were 151 contacts with the sample during that time.Results demonstrated that the ANP-led intervention and new model for OAM care was safe, highly acceptable to patients and staff and that related healthcare costs could be captured. Based on the success of this pilot study, the authors conclude that a community-based ANP-led integrated oncology care model for adults receiving OAMs is feasible, and a definitive trial is warranted.Trial registration ISRCTN, ISRCTN10401455. Registered 30 November 2020.

Prostatic Artery Embolization in Patients with Advanced Prostate Cancer: A Prospective Single Center Pilot Study.

To assess efficacy and safety of prostatic artery embolization (PAE) in patients with advanced prostate cancer (PCa). In this prospective single-center, single-arm, pilot study, 9 men with advanced PCa underwent PAE. PAE was performed with the use of 250-400µm Embozene microspheres (Boston Scientific, Natick, Massachusetts, USA). International Prostate Symptoms Score (IPSS), urinary peak flow (Qmax) and post-void residual urine volume (PVR) was assessed at 12 weeks and up to 12 months. Changes in total prostate volume (TPV) and tumor responses by PSA, changes in tumor volume and evaluation of tumor regression by multiparametric magnetic resonance imaging were assessed at 12 weeks after PAE. IPSS reduction in median 6 points (0-19) and a significant decrease in PVR from median 70 (20-600)mL to 10 (0-280)mL could be achieved within 12 weeks after PAE. Median TPV and tumor volumes (TV) increased slightly from 19.7 (6.4-110.8)mL to 23.4 (2.4-66.3)mL and 6.4 (4.6-18.3)mL to 8.1 (2.4-25.6)mL at a median of 12 weeks after the procedure. Significant tumor necrosis (≥ 50%) was found in one patient. Eight patients showed > 50% of viable tumor on post-PAE MRI according to MRI. Only one Clavien-Dindo Grade 1 adverse event related to PAE occurred. PAE with the use of 250-400 µm microspheres is feasible, safe and effective in some patients with advanced PCa regarding functional outcomes. A cytoreductive effect might be achieved in individual patients but must be further assessed. NCT03457805.

The Additional Value of Somatostatin Receptor Positron Emission Computed Tomography ([68Ga]Ga-DOTATOC PET/CT) Compared with Magnetic Resonance Imaging of the Head and Neck Region in Paraganglioma Patients: A Pilot Study.

In this single-center pilot study, retrospective data were obtained from consecutive patients between 2016 and 2023. Both MRI and [68Ga]Ga-DOTATOC PET/CT were performed within 12 months. The primary outcome was the location of HNPGLs. A total of 25 consecutive patients were included, and 7 patients (28.0%, p = 0.5) showed differences between the imaging modalities, of whom 5 patients had unexpected localizations with additional uptake by somatostatin receptors (SSTR) on the [68Ga]Ga-DOTATOC PET/CT. The authors recommend performing baseline imaging with [68Ga]Ga-DOTATOC PET/CT (if available) in variant carriers and using MRI/CT for follow-up according to the regional protocol, thereby shifting the gold standard for baseline imaging from MRI/CT to [68Ga]Ga-DOTATOC PET/CT.

Bronchial Cryo-Denervation for Severe Asthma: A Pilot Study

Introduction: Targeting the parasympathetic nervous system innervating the airway with pharmacologic products has been proved to improve the clinical outcomes of severe asthma. Bronchial cryo-denervation (BCD) is a novel non-pharmacologic treatment for severe asthma using an endobronchial cryo-balloon administered via bronchoscopy to denervate parasympathetic pulmonary nerves. Preclinical studies have demonstrated that BCD significantly disrupted vagal innervation in the lung. Methods: A total of 15 patients with severe asthma were enrolled in this prospective, single-center pilot study. Patients underwent bifurcated BCD treatment at a 30-day interval after baseline assessment. Follow-up through 12 months included assessment of adverse events, technical feasibility, and changes in pulmonary function; asthma control questionnaire-7 (ACQ-7); and asthma control test (ACT). Results: BCD was performed on all 15 severe asthma patients, with technical feasibility of 96.7%. There were no device-related and 2 procedure-related serious adverse events through 12 months, which resolved without sequelae. The most frequent nonserious procedure-related adverse event was increased cough in 60% (9 of 15) patients. Pulmonary function remained unchanged, and significant improvements from baseline ACQ-7 (mean, −1.19, p = 0.0032) and ACT (mean, 3.18, p = 0.0011) scores were observed since the first month’s follow-up after a single lung airway treatment, with similar trends till the end of the 12-month follow-up. Conclusion: This study provides the first clinical evidence of the safety, feasibility, and initial efficacy of BCD in patients with severe asthma.

Relationship Between COVID-19 and MINOCA: A Pilot Cross-Sectional Study

Introduction: Evidence suggests that COVID-19 infection increases the likelihood of myocardial infarction with no obstructive coronary arteries (MINOCA), particularly in females. This study hypothesizes that patients with COVID-19 and acute myocardial infarction (AMI) who underwent coronary angiography will have a higher proportion of MINOCA than those with AMI without COVID-19. Objective: This study aimed to assess if COVID-19 infection is associated with MINOCA in patients who underwent coronary catheterization. Methods: This was a single-center cross-sectional pilot study that gathered information using the electronic medical records of a tertiary care institution between February 2020 and October 2021. Patients were divided into two groups: those with AMI and COVID-19 (AMICOVID+) and those with AMI without COVID-19 (AMICOVID-). The primary outcome was to evaluate the relationship between COVID-19 and MINOCA, expressed in relative frequencies and p-values calculated by the Chi-squared test and corroborated by a sensitivity analysis using logistic regression. Results: Of the 28 patients that met the inclusion criteria, 14 (50%) had AMICOVID+, and 14 (50%) had AMICOVID-. MINOCA was significantly higher in the group with AMICOVID+ compared to AMICOVID- (85.7% vs. 21.4%. p = 0.001), showing no effect modification when sensitivity analysis was carried on. The raw data for statistical analyses was also included in the appendices. Conclusion: MINOCA was in a significantly higher proportion in the AMICOVID+ group than in the AMICOVID- group. However, this study had a small sample size; therefore, these results must be corroborated in different populations with larger sample sizes.

Cyclosporine A in hospitalized COVID-19 pneumonia patients to prevent the development of interstitial lung disease: a pilot randomized clinical trial

Post-COVID-19 interstitial lung disease (ILD) is a new entity that frequently causes pulmonary fibrosis and can become chronic. We performed a single-center parallel-group open-label pilot randomized clinical trial to investigate the efficacy and safety of cyclosporine A (CsA) in the development of ILD in the medium term among patients hospitalized with COVID-19 pneumonia. Patients were randomized 1:1 to receive CsA plus standard of care or standard of care alone. The primary composite outcome was the percentage of patients without ILD 3 months after diagnosis of pneumonia and not requiring invasive mechanical ventilation (IMV) (response without requiring IMV). The key secondary composite outcomes were the percentage of patients who achieve a response requiring IMV or irrespective of the need for IMV, and adverse events. A total of 33 patients received at least one dose of CsA plus standard of care (n = 17) or standard of care alone (n = 16). No differences were found between the groups in the percentage of patients who achieved a response without requiring IMV or a response requiring IMV. A higher percentage of patients achieved a response irrespective of the need for IMV in the CsA plus standard of care group although the RR was almost significant 2.833 (95% CI, 0.908–8.840; p = 0.057). No differences were found between the groups for adverse events. In hospitalized patients with COVID-19 pneumonia, we were unable to demonstrate that CsA achieved a significant effect in preventing the development of ILD. (EU Clinical Trials Register; EudraCT Number: 2020-002123-11; registration date: 08/05/2020).

A Pilot Study on the Safety and Adequacy of a Novel Ecofriendly Hemodialysis Prescription–Green Nephrology

Hemodialysis (HD) units require large quantities of water. To reduce water consumption without compromising the adequacy and safety of dialysis, we studied a novel HD prescription with high temperature and low flow dialysate. This was a single-center nonrandomized open-label cross-over pilot trial in patients with end-stage kidney disease on maintenance HD. Each participant was subjected to 3 different dialysis prescriptions for 1 month each as follows: (i) normal temperature with normal flow dialysate (NTNF prescription), (ii) high temperature with normal flow dialysate (HTNF prescription), and (iii) high temperature with low flow dialysate (HTLF prescription). The primary outcome, assessed at the end of each dialysis session, was the delivery of "adequate" dialysis, as defined by a single-pool Kt/V (spKt/V)≥1.2. Outcomes were evaluated by comparing the NTNF and HTLF prescriptions. A total of 863 sessions of HD were performed in 30 patients over 3 months, with 287 to 288 sessions in each of the 3 dialysis prescriptions. The primary outcome was not significantly different between the NTNF prescription (202 sessions [70.14%]) and the HTLF prescription (198 sessions [68.75%]) (odds ratio, 1.07; 95% confidence interval, 0.75 to 1.52; P= 0.45). The mean spKt/V and urea reduction ratio (URR) were not significantly different. Clinically evident hemodynamic instability occurred in only 1 dialysis session in the HTNF prescription. Increasing dialysate temperature while reducing dialysate flow rate (QD) can be used as a water conservation strategy without compromising the adequacy and safety of dialysis in young and hemodynamically stable patients. Reducing the QD from 500 ml/min to 300 ml/min reduces water consumption by 40%.