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Immune checkpoint inhibitor therapy linked to higher incidence of cardiovascular events

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September 07, 2022

2 min read

Disclosures:
Laenens reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.


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Immune checkpoint inhibitor therapy appeared associated with an increased risk for major adverse cardiovascular events among patients with cancer and a prior history of cardiovascular disease, according to results of a retrospective study.

The findings, published in Journal of Clinical Oncology, suggest routine thorough cardiovascular history, electrocardiography and echocardiography might identify patients who need regular cardiovascular follow-up during and after immune checkpoint inhibitor treatment, researchers noted.

Among patients with cancer who received immune checkpoint inhibitors
Data derived from Laenens D, et al. J Clin Oncol. 2022;doi:10.1200/JCO.21.01808.

Background

Immune checkpoint inhibitors (ICIs) have been known to cause immune-mediated myocarditis in some patients. However, incidence of other major adverse cardiovascular events after ICI therapy remains unknown, according to study background.

“The current literature on cardiovascular toxicity of ICIs consists mainly of case series,” Dorien Laenens, MD, cardiologist in the department of cardiology at University Hospitals Leuven in Belgium, and colleagues wrote. “Another limitation of the currently available data is that randomized clinical trials of ICIs focus on survival, response and disease control, usually [during] short follow-up periods.”

To address the lack of knowledge, researchers collected data from digital patient files of University Hospitals to identify incidence of and risk factors for major adverse cardiovascular events among 672 patients (median age, 65 years; 64.7% men) with cancer treated with ICIs, and compared incidence rates with patients with cancer not treated with ICIs and population controls after matching according to age, sex, cardiovascular history and cancer type.

Major adverse cardiovascular events — a composite of acute coronary syndrome, heart failure, stroke and transient ischemic attack — served as the primary endpoint. Acute coronary syndrome and heart failure served as secondary outcomes.

Median follow-up was 13 months (interquartile range, 6-22).

Findings

Overall, 572 patients received only one line of ICI therapy, 90 patients received two lines of therapy, eight patients received three lines and two patients received four lines. More than half of patients (54.9%) died — with 1.9% deemed cardiovascular deaths.

Researchers reported a 10.3% incidence of major cardiovascular events, with a median time to event of 5 months.

Results of multivariable analysis showed having a history of heart failure (HR = 2.27; 95% CI, 1.03-5.04) and valvular heart disease (HR = 3.01; 95% CI, 1.05-8.66) remained significantly associated with major adverse cardiovascular events.

“Cumulative incidence rates were significantly higher in the ICI group compared with the cancer cohort not exposed to ICI and the population controls, mainly driven by a higher risk of heart failure events,” the researchers wrote.

Implications

The findings reinforce the clinical relevance of a cardiovascular workup of patients with cancer before exposure to ICI treatment, particularly in those with preexisting cardiovascular disease, the researchers wrote.

“Prospective or retrospective all-comer studies with bigger cohorts are essential for capturing true incidence of major cardiac events in daily practice,” they continued.

“Concomitant cardiovascular disease is often an exclusion criterion in clinical trials. This might be one of the reasons why this type of toxicity is underreported in phase 3 trials. In addition, toxicity is often not part of the follow-up when treatment within the context of the study is ceased. Cohort studies like ours can compensate for these shortcomings.”

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Building community in online conferences, events (opinion) | Inside Higher Ed

Building community in online conferences, events (opinion) | Inside Higher Ed

We read, with interest, Nolan Higdon and Allison Butler’s recent Inside Higher Ed piece, “Conferencing Critically in a COVID-19 World,” in which they discuss various drawbacks to remote and hybrid conferences. While we agree with some of the key points in their article, we feel that others underestimate the potential of virtual and hybrid professional development.

One statement in Higdon and Butler’s article stood out for us: “One additional risk of a remote conference—and, by extension, remote education—is that it keeps us isolated from each other.” People who have been teaching and connecting online since before the pandemic would disagree with this notion, especially those who centered humanizing approaches to online learning and pedagogies of care; many others learned during the pandemic how to build community and create affective ties with learners and peers globally, without gathering in a shared physical locale. Moreover, being “in person” does not necessarily result in less isolation. In-person events can be isolating for anyone who is not already part of the in crowd.

We recently worked with others to organize Equity Unbound’s #MYFest22, a virtual event that sought to center community and support, and rethink the many pitfalls of online, in-person and hybrid events that we’ve seen in the past two years, and even before the pandemic. We kept MYFest virtual because we agree with Higdon and Butler that virtual conferences can promote better access for those without funds or freedom to travel, and because virtual conferences are certainly better for climate justice.

The inaugural Mid-Year Festival 2022, aka #MYFest22, from Equity Unbound—an equity-focused, connected intercultural learning network that co-creates diverse, open learning experiences—was not a conference per se, nor was it similar to anyone’s local professional development. It was not a series of one-off, high-cost, multisession workshops offered by a large contracted organization. MYFest was designed to be a three-month-long “recharge and renewal experience” with a “choose-your-own-learning journey” approach, exploring a variety of themes, including critical pedagogy and open education and digital literacies. In addition, two themes intentionally addressed isolation: “well-being and joy” and “community building and community reflection.” More than 300 participants from five continents joined us.

We offer here ideas for what organizers of online events can learn from MYFest. Inspired by a “call for promoting ownership, equity, and agency in faculty development via connected learning,” we aimed to deepen adult learning by leveraging human connection, respecting agency and self-determination (heutagogy), designing for equity, and recognizing the need to make time for critical self-reflection—both individually and in community—in order to support cumulative transformative learning.

1. Have a diverse community of organizers.

To capture a diverse audience, design with diverse organizers. Many academic events are organized by people who are mostly from one institution, one country or one professional organization, yet claim to offer professional development for diverse participants from all over the world. Instead, #MYFest22 built on relationships among 14 organizers from four different countries (Canada, Egypt, South Africa and the United States), many of whom have built trust and collegial friendship online as part of a thriving, intersecting long-term personal learning network with community values of mutual support. We have supported each other through illness and wellness, grief and joy, frustrations and solutions. Our ongoing conversations have helped us realize just how significant a gap there is in traditional professional development worldwide.

2. Aspire toward participant agency and reflection.

Educator and author Sherri Spelic has observed that badly designed professional development for educators tends to be “undifferentiated.” In contrast, MYFest was a “build-your-own-learning journey” experience over three months, a “buffet approach” (participants chose sessions of interest, could change selections at any time and could attend as much or as little as suited them). In addition, MYFest was declared a No FOMO (fear of missing out) experience. If a participant’s life and schedule did not permit attendance for certain gatherings and activities, this did not result in being left behind.

Three months (not two to three days!) gave participants time to build community and relationships synchronously and asynchronously, and opened up room for reflection and cumulative transformative learning. The significance of both individual and collective reflection was the glue of the MYFest experience, including some sessions focused on group reflection, exercises with individual written reflections and a call for curation of participant-created multimodal artifacts and writings.

3. Foster global connections and community with intentionally equitable hospitality.

We sought to foster global online conversations through skillful facilitation and by embracing “intentionally equitable hospitality,” designing sessions in ways that strive toward ensuring everyone participates as fully as possible in the ways they feel most comfortable, and inviting the most marginalized voices. We sought to host with the “generous authority” Priya Parker promotes (in Parker’s words, a gathering run with generous authority is one “run with a strong confident hand, but … run selflessly, for the sake of others”). Participants had various modes of participation, synchronous or asynchronous, and there were options to go to a “quiet room” during breakout room activities if someone did not want to chat that day. There was never an expectation of cameras on, or of oral participation if someone preferred typing in the chat. Slides were provided ahead of time where possible, with alternative text for images. Automated live transcription was enabled in live sessions. Chats were lively in most sessions, and opportunities to participate anonymously via Google docs, Google Jamboard or polling tools came up throughout. Sessions were recorded, unless the conversations were very personal and the more equitable choice was not to record them in order to provide a safe space. Participants were often invited to write privately and share only what they felt comfortable sharing.

4. Co-create and experience community and joy throughout.

The MYFest participants did not meet to talk about community and well-being. Rather, we met to experience and co-create community and well-being. MYFest facilitators have expertise in participatory approaches to online facilitation, including the use of community-building approaches and “liberating structures” (these are “easy-to-learn microstructures that enhance relational coordination and trust” meant to “quickly foster lively participation in groups of any size”).

Community (and the trust that is the foundation of healthy community) cannot be established with one or two speed networking sessions at an event. We laid the foundation for MYFest with at least one weekly community building engagement, making time for people to get to know one another in small groups with creative prompts like the Fast Friends protocol, and to reflect together creatively, through prompts like ice cream/broccoli and spiral journal. We welcomed and engaged with participants as they wove in and out of each other’s lives, building and strengthening connections over time.

5. Schedule wisely. Resist Zoom fatigue and decision fatigue.

MYFest exemplified what Spelic suggests: “professional development that is wisely scheduled.” We spread our offerings out over three months, avoided overlapping sessions and had no more than three events per day. We therefore avoided the familiar Zoom fatigue as well as decision fatigue. Some MYFest events were threaded as “tracks,” where one may attend multiple sessions and do some asynchronous work around the same topic, an approach that opens up the potential of “cohort” congeniality. In our Slack channel, MYFest participants could discover, connect and share with new colleagues at any time across multiple themes and tracks.

6. Embrace emergence: welcome and leverage participant expertise.

MYFest sought to be “emergent” by actively building on participant expertise. Every session in MYFest encouraged participants to bring and share their expertise. Additionally, there were special sessions within MYFest inviting participants to contribute their own expertise in building community—contributing those ideas to the OneHE/Equity Unbound community-building resource site—so these sessions built on participant expertise while also contributing to an open resource that is available to all on the open web.

7. Make it family-friendly.

Another unique aspect of the MYFest experience was the intuitive involvement of family and friends. By focusing on well-being and joy, as well as critical discussions, we intentionally designed programming for the entire family. MYFest participants brought both (grand)parents and children to certain threads, embracing the power of intergenerational learning and connection. The Reader’s Theater invited children and adults to co-read plays together online, and MineFest invited children from all over the world to play Minecraft together safely. MYFest therefore addressed Spelic’s call for professional development that “acknowledges [educators’] full humanity in the learning process.”

8. Go beyond access and focus on accessibility.

Compared to in-person events, there’s more flexibility to make online conferences affordable, as adding participants in a virtual event does not have an incremental cost. It is therefore easier to create a system for scholarships or waivers for folks who are marginalized or do not have institutional funding. In the case of MYFest, we were awarded a Hewlett Foundation grant that allowed for the foundational overhead cost, and it covered the labor of the main facilitators and some of the invited guest facilitators, as well as the technology needed to run the event. And while MYFest was not advertised as a free event, there were multiple discounts available, and also the possibility to attend for free via a waiver.

By keeping the conference virtual, we avoided the costs of accommodation and travel associated with in-person events, as well as the logistical and social barriers to travel for parents of young children, people with disabilities and people who lack visa privilege. And, in the case of COVID-19 (and now monkeypox), people with compromised immunity.

Despite these efforts, we recognize, as Higdon and Butler do, that while “digital may be more accessible, it is not entirely accessible” all the time and for everyone. Differences in time zones meant that some sessions would often fall at an inconvenient time for people (particularly those located in East Asia and Oceania). We intentionally offered some sessions in “time zone sweet spots” that might work on all continents. But these attempts can never be perfect. And of course, some people may have no internet access, expensive internet access, intermittent electricity or low bandwidth.

However, accessibility goes beyond internet access. An accessible event should mean that when people join, they feel included, they feel they can access learning and belong to groups and learn in ways that reach them where they are. It means that people with different abilities can learn comfortably without constantly needing to ask for special accommodations, people from across the globe can find relevance in the work and organizers are always open to feedback and suggestions.

As our colleague Kate Bowles said to us, “The pandemic has also taught us that all sorts of fixed fittings turned out to be moveable: scheduling, assessment modes, grades, logistics of scale. We’re now somewhat free not to put them back as they were.” (Twitter DM shared with permission.)

Let’s not put exclusionary professional development practices back to what they were before March 2020. A more worthy goal is to aspire toward equitable, accessible professional learning environments that can bring us joy in community and promote the transformative learning we hunger for.

Acknowledgment

The authors would like to acknowledge the entire MYFest organizing team (all bios here). We would also like to acknowledge our guest facilitators and participants, who have all enriched the MYFest experience.

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Higher Serum Urea Levels in CKD Predict Cardiovascular Events

Blood sample

Elevated serum urea levels in patients with nondialysis-dependent chronic kidney disease (CKD) predict cardiovascular events and death, according to study findings presented at the European Renal Association (ERA) 59th Congress held in Paris, France, and virtually.

Ziad Massy, MD, PhD, of Ambroise Paré University Hospital, Boulogne-Billancourt, France, and colleagues stratified 2507 patients from the CKD-REIN cohort by baseline serum urea level. Over a median of 3 years, 451 patients experienced their first atheromatous or nonatheromatous cardiovascular event. The overall incidence rate was 7.1 per 100 person-years.

In adjusted analyses, patients with serum urea levels in the top tertile (15.1 mmol/L or higher) had a significant 2.1-fold increased risk for cardiovascular events compared with those who had levels in the bottom tertile (less than 10.5 mmol/L), the investigators reported. The middle tertile of serum urea (10.5–15.1 mmol/L) was associated with a nonsignificant 1.3-fold increased risk of cardiovascular events. The cardiovascular events rate was 4.1, 6.3, and 11.6 per 100 person-years for the bottom, middle, and top tertile, respectively. Of the full cohort, 54% had a history of cardiovascular disease.


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Over a median 4.8 years, 407 patients died before initiating kidney replacement therapy at a rate of 4.0 per 100 person-years. Compared with the bottom tertile of serum urea, the risk for all-cause mortality was a nonsignificant 1.3-fold higher for the middle tertile and a significant 1.7-fold higher for the top tertile, the investigators reported.

“Beyond [cardiovascular] risk factors including eGFR, this hypothesis-generating study suggests that serum urea level is a predictor of cardiovascular outcomes in patients with moderate to advanced CKD,” Dr Massy’s team concluded in a study abstract. Further research is needed to confirm the findings and explore mechanisms, including whether urea is a direct or indirect uremic toxin, as some studies indicate.

Reference

Laville S, Couturier A, Lambert O, et al. Serum urea levels and cardiovascular disease in patients with chronic kidney disease. Presented at: ERA 59th Congress; May 19-22, 2022, Paris, France, and virtual. Abstract MO496.

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COVID risks higher from small indoor events than large outdoor ones: research

COVID risks higher from small indoor events than large outdoor ones: research

Outdoor events are safer than indoor events in regards to potential COVID-19 transmission, according to a newly released comparative study of two hypothetical events in Austin, Texas.

A study from the University of Texas and the city of Austin considered the COVID-19 transmission risks at two events: a business conference with 3,000 attendees during a pandemic surge and an outdoor festival with 50,000 attendees in a low transmission period.

Despite the attendance at the hypothetical outdoor festival being more than 10 times higher than at the indoor business conference, the study’s authors estimated that the festival would result in the infection of only twice as many people in the community during and after the event.

To calculate the COVID-19 risks from the two events, they considered multiple factors: the structure of the event, including its size, duration, density and venue; the state of the pandemic, including the local prevalence of the virus and the epidemiological properties of current variants; any risk-reduction measures introduced by event organizers; and local demographics.

Using that information, the study’s authors said they first estimated the number of attendees who would arrive infected at the hypothetical events. To do this, they said they used the COVID-19 school risk dashboard to estimate the incidence rates of COVID-19 in every U.S. county and assumed that an attendee arriving infected correlated directly to the incidence rate of infection in their home county.

They said they then estimated the number of attendees who would be infected at the event and finally the total number of infections in Austin that would stem from the event over a four-week period.

The study’s authors said that the risks of transmission from an event can be significantly reduced by requiring proof of vaccination, a negative COVID-19 test just prior to the event and/or the wearing of face masks during the event.

The results of the study also showed that limiting the number of attendees, physically spacing out activities and selecting outdoor and well-ventilated sites can significantly mitigate risks, the authors said.

However, the authors cautioned that they made “a number of critical assumptions that may not hold for all events, especially as SARS-CoV-2 and our arsenal of medical countermeasures continues to evolve.”

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ED Meds Linked to Higher Risk of Ocular Adverse Events

A photo of a man holding a Viagra pill and a glass of water.

Regular users of common medications for erectile dysfunction (ED) are at a higher risk for ocular adverse events, according to a large cohort study.

Among over 200,000 men using phosphodiesterase type 5 inhibitors (PDE5Is), the adjusted incidence rate ratio (IRR) for the composite endpoint of serous retinal detachment (SRD), retinal vascular occlusion (RVO), and ischemic optic neuropathy (ION) was 1.85 (95% CI 1.41-2.42), reported Mahyar Etminan, PharmD, MSc, of the University of British Columbia in Vancouver, and colleagues in JAMA Ophthalmology.

When analyzed by individual outcome, the adjusted IRRs were:

  • 2.58 (95% CI 1.55-4.30) for SRD
  • 1.44 (95% CI 0.98-2.12) for RVO
  • 2.02 (95% CI 1.14-3.58) for ION

These ocular adverse events have previously been reported with use of PDE5Is, but mostly in the form of anecdotal studies that produced inexact estimates for these risks. “Results of this study suggest that individuals who regularly use PDE5Is should be cognizant of ocular adverse events associated with these drugs and alert their physicians if they experience any visual deficits,” the authors wrote.

In an accompanying commentary, Brian L. VanderBeek, MD, MPH, MSCE, of the University of Pennsylvania in Philadelphia, and Maureen G. Maguire, PhD, of the JAEB Center for Health Research in Tampa, Florida, noted that “this study also had a weakness that has plagued previous inquiries into the ocular adverse events related to PDE5I use.”

Many of the risk factors for the indications for using PDE5Is — hypertension, diabetes, and coronary artery disease — are also risk factors for SRD, RVO, and ION, they added, and the prevalence of these risk factors in this study was substantially higher among cases versus controls.

When Etminan and colleagues restricted the primary analysis to cases without hypertension, diabetes, or coronary artery disease, the IRR remained high, at 2.12 (95% CI 1.34-3.43).

However, “residual confounding could have occurred owing to a lack of adjustment for other common risk factors between erectile dysfunction and the adverse events,” VanderBeek and Maguire wrote. Furthermore, “residual confounding frequently yields overestimation of the risk ratios.”

While the study’s findings suggest that PDE5I use may be associated with serious ocular adverse events, causality can’t be proved by using only observational data, they concluded. “Future studies that reduce residual confounding may bolster the confidence in conclusions regarding PDE5I use and these adverse events.”

Data for this study came from the PharMetrics Plus database from January 2006 through December 2020. The study cohort included 213,033 users of PDE5Is, including sildenafil (Viagra, Revatio), tadalafil (Cialis), vardenafil (Levitra), and avanafil (Stendra), who did not use any of the drugs in the year before study entry. The nested case-control analysis included 278 cases of SRD, 628 of RVO, and 240 of ION, as well as 4,584 controls. Mean age in both the case and control groups was 64.6 years.

Risk factors were more common in case patients versus controls: hypertension (24.6% vs 8.9%), diabetes (38.1% vs 26.1%), coronary artery disease (36.1% vs 24.0%), and sleep apnea (15.5% vs 10.6%).

An analysis comparing the risk between men taking five or more PDE5I prescriptions compared with those taking fewer than five prescriptions showed a dose-response association with ocular adverse events (IRR 2.90, 95% CI 1.15-3.81 vs IRR 1.74, 95% CI 1.10-6.77).

When analyzed by individual outcome in this analysis, the adjusted IRRs were:

  • 1.90 (95% CI 1.41-2.55) vs 1.73 (95% CI 1.14-2.64) for SRD
  • 2.39 (95% CI 1.38-4.14) vs 3.30 (95% CI 1.48-7.38) for RVO
  • 1.55 (95% CI 1.00-2.40) vs 1.25 (95% CI 0.70-2.21) for ION

Etminan and colleagues acknowledged that they only had data on drug dispensation and not on actual consumption, which was a study limitation.

  • author['full_name']

    Mike Bassett is a staff writer focusing on oncology and hematology. He is based in Massachusetts.

Disclosures

This study was funded by the Department of Ophthalmology and Visual Sciences at the University of British Columbia.

Etminan reported no disclosures. A co-author reported financial support from the Novartis Advisory Board and Roche Advisory Board outside the submitted work.

VanderBeek reported receiving consulting fees from EyePoint Pharmaceuticals. Maguire reported no disclosures.

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Leakage after left atrial appendage occlusion associated with higher risk of adverse events

Leakage after left atrial appendage occlusion associated with higher risk of adverse events

Patients who had leakage to the left atrial appendage due to incomplete device sealing after left atrial appendage occlusion (LAAO) experienced more clotting and bleeding events within a year following their procedure compared with patients who had no leaking, according to a study presented at the American College of Cardiology’s 71st Annual Scientific Session.

The study, which included data from more than 50,000 patients, is by far the largest to date to assess how leaking after LAAO affects the likelihood of adverse health outcomes. The results suggest that even small leaks are associated with a 10%-15% higher risk of adverse events.

Our study shows that any leak matters, and we should find ways to optimize the procedure to minimize the proportion of patients who end up with leaks. Because this is a preventative procedure, it is important to find ways to master this and prevent leaks from happening. Fortunately, there are indications that leaking might be less common with newer devices and improved techniques.”


Mohamad Alkhouli, MD, professor of medicine at Mayo Clinic and study’s lead author

Stroke is a major concern in patients with atrial fibrillation (AFib), the most common heart rhythm disorder. Blood thinners are the primary medical option for reducing the risk of strokes, which are caused when a blood clot blocks an artery in the brain; however, blood thinners are not suitable for many patients due to drug interactions, bleeding complications, cost, frequent blood checks with warfarin or other reasons. The WATCHMAN device, approved by the U.S. Food and Drug Administration in 2015, is designed to help prevent strokes by sealing off the heart’s left atrial appendage where blood can pool and clot. It is now widely used to reduce the risk of stroke in patients with AFib who cannot tolerate long-term use of blood thinners.

For the study, researchers analyzed data from 51,333 patients who underwent LAAO procedures with the WATCHMAN device between 2016-2019 as recorded in the ACC’s LAAO Registry, a database that includes nearly all LAAO procedures conducted in the U.S. and is part of the College’s NCDR registries. Echocardiograms were used to classify the size of any leaks around the device an average of 45 days after a LAAO procedure, a standard part of the clinical follow-up for this procedure. Registry data also included information about subsequent adverse health events occurring in the years after the procedure.

Overall, researchers found that 73.4% of patients had no leaks, 25.8% had small leaks (greater than zero but less than 5 millimeters across) and 0.7% had large leaks (greater than 5 millimeters)—proportions similar to those reported in previous registry studies and clinical trials.

While relatively few patients—roughly 2%-3%—experienced adverse events in the year following their LAAO procedure, the researchers found that the relative risk of these events varied significantly between patients with and without leaks. Compared to patients who had no leaking, those with small leaks had a 10% higher relative risk of suffering any major adverse events, an 11% higher relative risk of major bleeding complications, and a 15% higher relative risk of clotting-related events, including stroke, systemic embolization and transient ischemic attacks.

The study revealed no significant differences in the rate of adverse events between patients with large leaks and those with small or no leaks, which Alkhouli said is likely due to the use of anticoagulants in these patients. Instructions for the WATCHMAN device indicate that patients who have residual leaks greater than 5 millimeters across should be considered to have a failed procedure, and they are generally treated with anticoagulants.

Alkhouli said leaking is relatively common with LAAO procedures because the size and shape of the left atrial appendage varies widely from person to person, which can make it difficult for operators to position the device in a way that completely seals off the appendage. He noted that the shape of the appendage portion where the leaked blood flows into could affect the associated risks. More recent technologies, such as the use of CT scans to image the appendage and software that allows users to practice the procedure virtually before operating on a patient, could help operators place the WATCHMAN device in a more optimal position. Alkhouli said newer generation WATCHMAN device designs, which were introduced in 2021, could also help to reduce the risk in some patients.

The study was based on registry data reflecting real-world practices, meaning variations in the measurement of leaks could exist and may impact the results of the study, Alkhouli said. He added that future studies could help clarify whether using blood thinners in some patients with leaks smaller than 5 millimeters would be helpful in reducing stroke risk.

This study was simultaneously published online in the JACC: Clinical Electrophysiology at the time of presentation. The study was funded by Boston Scientific, maker of the WATCHMAN device.

Alkhouli will present the study, “Residual Leaks Post Left Atrial Appendage Occlusion,” on Sunday, April 3, at 12:15 p.m. ET / 16:15 UTC in the Main Tent, Hall D.

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Higher Rates of Adverse Obstetric, Delivery, CV Events Among Black Women With CHD

Higher Rates of Adverse Obstetric, Delivery, CV Events Among Black Women With CHD

During delivery, Black women with a diagnosis of congenital heart disease (CHD) are more likely to experience adverse obstetric and cardiovascular (CV) events compared with their White and Hispanic counterparts. These findings were presented at the American College of Cardiology 71st Annual Scientific Session & Expo, from April 2nd through 4th, in Washington, DC.


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Recognizing the complexity of care needed among pregnant women with CHD, investigators sought to examine adverse delivery events, including hypertension during pregnancy, preeclampsia, and preterm delivery, with race serving as the primary independent variable. The Rao-Scott chi-square test was used to evaluate between-race differences.

The National Inpatient Sample database was utilized to identify hospitalizations for delivery among women aged 18 years or older between January 1, 2001, and December 31, 2018. During the study period, an estimated 58.1 million women were hospitalized for delivery, of whom 45,250 had concurrent CHD diagnoses. Among these hospitalizations, 66% of the patients were White, 16% were Hispanic, and 11% were Black.

Results of the study revealed that the rate of obstetric complications was significantly higher among Black women compared with White and Hispanic women (44%, 33%, and 37%, respectively; P <.001), which was attributable mainly to hypertension during pregnancy, preeclampsia, and preterm delivery.

Additionally, fetal events were statistically significantly highest among Black patients compared with White and Hispanic patients (36%, 28%, and 30%, respectively;

P <.001). These fetal event were mostly driven by growth restriction and malformation.

The occurrence of CV events, particularly heart failure, was also significantly highest among Black women compared with White and Hispanic women (4%, 2%, and 2%, respectively; P <.001).

This study found that Black women with CHD are more likely to experience adverse CV outcomes during pregnancy compared with White and Hispanic women. “There is a need for further exploration of the racial disparities in outcomes among women with CHD to identify potential causes and devise strategies to mitigate these disparities,” the researchers wrote.

Disclosure: None of the study authors has declared affiliations with biotech, pharmaceutical, and/or device companies.  

Reference  

Petersen J. Racial disparities in outcomes of delivery and cardiac complications among pregnant women with congenital heart disease. Presented at: American College of Cardiology 71st Annual Scientific Session & Expo; April 2-4, 2022; Washington, DC.

Visit Cardiology Advisor’s conference section for complete coverage of ACC 2022.

 

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Indoor Air Quality During Wildfire Smoke Events: Academic Minute | Inside Higher Ed

Indoor Air Quality During Wildfire Smoke Events: Academic Minute | Inside Higher Ed

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Today on the Academic Minute, part of Portland State University Week: Elliott Gall, assistant professor of mechanical and materials engineering, examines how best to live with the effects of wildfire smoke. Learn more about the Academic Minute here.

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Rates of neurological events higher with SARS-CoV-2 infection than with COVID-19 vaccine

Source: Adobe Stock.

March 23, 2022

2 min read


Disclosures:
Li reports receiving the Clarendon Fund and Brasenose College scholarship from the University of Oxford to support her DPhil study. Please see the study for all other authors’ relevant financial disclosures.


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Incidence rates for Bell’s palsy, encephalomyelitis and Guillain-Barré syndrome were higher in unvaccinated people with SARS-CoV-2 infection compared with those vaccinated against COVID-19, researchers reported in BMJ.

“Immune-mediated neurological disorders have been identified as adverse events of special interest by regulators, such as the FDA in the U.S. and the EMA in Europe,” Xintong Li, MHS, a doctoral student at the Center for Statistics in Medicine at the University of Oxford, and colleagues wrote. “These adverse events of special interest have been closely monitored during immunization campaigns, and several severe neurological disorders were reported as rare adverse events during the first clinical trials of COVID-19 vaccines.”


Source: Adobe Stock.

Source: Adobe Stock.

Li and colleagues conducted a population-based, historical rate comparison study using primary care records from the United Kingdom and Spain to assess rates of neurological events in 8,330,497 individuals who received at least one dose of a COVID-19 vaccine and in 735,870 unvaccinated individuals who tested positive for SARS-CoV-2.

Investigators assessed incidence rates for Bell’s palsy, encephalomyelitis and Guillain- Barré syndrome for the vaccinated group 21 days after receiving a vaccine dose and 90 days post-infection for those who were unvaccinated.

Among 3,776,803 participants who received a vaccine dose from AstraZeneca, there were 117 observed cases of Bell’s palsy, compared with 164.5 expected cases (standardized incidence ratio = 0.71; 95% CI, 0.59-0.85). Among 1,693,453 participants who received a dose from Pfizer, 46 cases of Bell’s palsy were observed compared with 116.4 expected cases (SIR = 0.40; 95% CI, 0.30-0.53). Participants who tested positive for SARS-CoV-2 infection had a reported 53 cases, higher than the 39.8 expected cases (SIR = 1.33; 95% CI, 1.02-1.74).

Post-vaccine rates of encephalomyelitis and Guillain-Barré syndrome were consistent with expected rates in both vaccination groups. However, higher rates for both conditions were reported in the SARS-CoV-2 group (encephalomyelitis: SIR = 6.89; 95% CI, 3.82-12.44 and Guillain-Barré syndrome: SIR = 3.53; 95% CI, 1.83-6.77).

“We found no safety signal for any of the studied immune-mediated neurological events after vaccination against COVID-19,” Li and colleagues wrote. “Infection with SARS-CoV-2 was, however, associated with an increased risk of Bell’s palsy, encephalomyelitis and Guillain-Barré syndrome.”