In response to the COVID-19 pandemic, we rapidly implemented a plasma coordination center, within two months, to support transfusion for two outpatient randomized controlled trials. The center design was based on an investigational drug services model and a Food and Drug Administration-compliant database to manage blood product inventory and trial safety.

A core investigational team adapted a cloud-based platform to randomize patient assignments and track inventory distribution of control plasma and high-titer COVID-19 convalescent plasma of different blood groups from 29 donor collection centers directly to blood banks serving 26 transfusion sites.

We performed 1,351 transfusions in 16 months. The transparency of the digital inventory at each site was critical to facilitate qualification, randomization, and overnight shipments of blood group-compatible plasma for transfusions into trial participants. While inventory challenges were heightened with COVID-19 convalescent plasma, the cloud-based system, and the flexible approach of the plasma coordination center staff across the blood bank network enabled decentralized procurement and distribution of investigational products to maintain inventory thresholds and overcome local supply chain restraints at the sites.

The rapid creation of a plasma coordination center for outpatient transfusions is infrequent in the academic setting. Distributing more than 3,100 plasma units to blood banks charged with managing investigational inventory across the U.S. in a decentralized manner posed operational and regulatory challenges while providing opportunities for the plasma coordination center to contribute to research of global importance. This program can serve as a template in subsequent public health emergencies.

This study describes the illness burden in the first year of life for children with single-ventricle heart disease, using the metric of days alive and out of hospital to characterize morbidity and mortality.

This is a retrospective single-centre study of single-ventricle patients born between 2005 and 2021 who had their initial operation performed at our institution. Patient demographics, anatomical details, and hospitalizations were extracted from our institutional single-ventricle database. Days alive and out of hospital were calculated by subtracting the number of days hospitalized from number of days alive during the first year of life. A multivariable linear regression with stepwise variable selection was used to determine independent risk factors associated with fewer days alive and out of hospital.

In total, 437 patients were included. Overall median number of days alive and out of hospital in the first year of life for single-ventricle patients was 278 days (interquartile range 157–319 days). In a multivariable analysis, low birth weight (<2.5kg) (b = −37.55, p = 0.01), presence of a dominant right ventricle (b = −31.05, p = 0.01), moderate-severe dominant atrioventricular valve regurgitation at birth (b = −37.65, p < 0.05), index hybrid Norwood operation (b = −138.73, p < 0.01), or index heart transplant (b = −158.41, p < 0.01) were all independently associated with fewer days alive and out of hospital.

Children with single-ventricle heart defects have significant illness burden in the first year of life. Identifying risk factors associated with fewer days alive and out of hospital may aid in counselling families regarding expectations and patient prognosis.

Various water-based heater-cooler devices (HCDs) have been implicated in nontuberculous mycobacteria outbreaks. Ongoing rigorous surveillance for healthcare-associated M. abscessus (HA-Mab) put in place following a prior institutional outbreak of M. abscessus alerted investigators to a cluster of 3 extrapulmonary M. abscessus infections among patients who had undergone cardiothoracic surgery.

Investigators convened a multidisciplinary team and launched a comprehensive investigation to identify potential sources of M. abscessus in the healthcare setting. Adherence to tap water avoidance protocols during patient care and HCD cleaning, disinfection, and maintenance practices were reviewed. Relevant environmental samples were obtained. Patient and environmental M. abscessus isolates were compared using multilocus-sequence typing and pulsed-field gel electrophoresis. Smoke testing was performed to evaluate the potential for aerosol generation and dispersion during HCD use. The entire HCD fleet was replaced to mitigate continued transmission.

Clinical presentations of case patients and epidemiologic data supported intraoperative acquisition. M. abscessus was isolated from HCDs used on patients and molecular comparison with patient isolates demonstrated clonality. Smoke testing simulated aerosolization of M. abscessus from HCDs during device operation. Because the HCD fleet was replaced, no additional extrapulmonary HA-Mab infections due to the unique clone identified in this cluster have been detected.

Despite adhering to HCD cleaning and disinfection strategies beyond manufacturer instructions for use, HCDs became colonized with and ultimately transmitted M. abscessus to 3 patients. Design modifications to better contain aerosols or filter exhaust during device operation are needed to prevent NTM transmission events from water-based HCDs.

External natural events, such as the COVID-19 pandemic, can contribute to increased stress, depression and anxiety in pregnant persons. Thus far, studies on the impact of maternal mental health during the pandemic on perinatal outcomes have been conflicting.

Assess the impact of prenatal mental health during the COVID-19 pandemic on preterm birth (PTB) and low birthweight (LBW).

Pregnant individuals, >18 years were recruited in Canada, their data were collected through a web-based questionnaire. Our analysis includes data on individuals recruited between 06/2020 and 08/2021, who completed questionnaires at baseline and 2-month post-partum. Data on maternal sociodemographic, comorbidities, medication, mental health measures (Edinburgh Perinatal Depression Scale, General Anxiety Disorder-7, stress), hardship (CONCEPTION study Assessment of Stress from COVID-19 –150 points), gestational age at delivery and birth weight were self-reported. PTB defined as delivery before 37 weeks of gestation. LBW defined as birth weight less than 2,500 grams.

A total of 1,265 and 1,233 participants were included in the analyses of PTB and LBW, respectively. After adjusting for potential confounders, we found no differences between prenatal mental health and PTB ([depression [adjusted RR [aRR] 1.01, CI 95% 0.91 to 1.11], anxiety [aRR 1.04, CI 95% 0.93 to 1.17], stress [aRR 0.88, CI 95% 0.71 to 1.10], hardship [aRR 1.00, CI 95% 0.96 to 1.04]). However, we found that the risk of PTB was increased with ethnicity/race (aRR 3.85, CI 95% 1.35 to 11.00), obstetrician/gynecologist follow-up (aRR 2.77, CI 95% 1.12 to 6.83). We didn’t find any significant association between prenatal mental health and LBW. However, annual household income, previous delivery were associated with a decreased risk of LBW (aRR 0.15, CI 95% 0.05 to 0.49; aRR 0.39, CI 95% 0.20 to 0.77, respectively).

Conclusion: No association was found between prenatal mental health during the COVID-19 pandemic and the risk of PTB or LBW. However, it is imperative to continue the follow-up of mothers and their offspring in order to detect early any long-term health problems.

None Declared

To establish the epidemiology of cardiac implantable electronic device (CIED) infections in Alberta, Canada, using validated administrative data.

Retrospective, population-based cohort study.

Alberta Health Services is a province-wide health system that services all of Alberta, Canada.

Adult patients who underwent first-time CIED implantation or generator replacement in Alberta, Canada, between January 1, 2011, and December 31, 2019.

CIED implant patients were identified from the Paceart database. Patients who developed an infection within 1 year of the index procedure were identified through validated administrative data (International Classification of Diseases, Tenth Revision in Canada). Demographic characteristics of patients were summarized. Logistic regression models were used to analyze device type, comorbidities, and demographics associated with infection rates and mortality.

Among 27,830 CIED implants, there were 205 infections (0.74%). Having 2 or more comorbidities was associated with higher infection risk. Generator replacement procedures (odds ratio [OR], 0.55; 95% confidence interval [CI], 0.34–0.84; P = .008), age increase of every 10 years (OR, 0.73; 95% CI, 0.66–0.82; P ≤ .001), and index procedure after 2014 were associated with decreased risk. Comparing the infected to uninfected groups, the hospitalization rates were 2.63 compared to 0.69, and the mortality rates were 10.73% compared to 3.49%, respectively (P < .001).

There is a slightly lower overall rate of CIED infections Alberta, Canada compared to previously described epidemiology. Implants after 2014, and generator replacements showed a decreased burden of infection. Patients with younger age, and 2 or more comorbidities are at greatest risk of CIED infection. The burden of hospitalization and mortality is substantially higher in infected patients.