More Data Showing Increased Cardiovascular Risks with COVID-19 & Vaccination Reduces This Risk

Two recent studies show that COVID-19 infection increases the risk of major cardiovascular outcomes.

This case-control study leveraged a large commercial insurance database and found increased rates of adverse outcomes over a 1-year period for a post-COVID-19 cohort surviving the acute phase of illness. Methods: An index month was set by adding 30 days to the COVID-19 diagnosis date (this study looked at outcomes starting one month after diagnosis).

This study used the data from the US Collaborative Network in TriNetX. From a cohort of more than 42 million records between 1 January 2019 and 31 March 2022, a total of 4,131,717 participants who underwent SARS-CoV-2 testing were recruited.

Eric Topol: Summary of studies relating cardiovascular outcomes:

My take: Many detractors of vaccination have focused on potential cardiac adverse events. These studies indicate that COVID vaccination provides protection against major cardiovascular outcomes

U.S. News & World Report’s Flawed Rankings Plus One

HJ Humphrey, D Levinson. Stat. 11/22/22. Deans: Dump that USNWR ‘best medical school’ survey Thanks to John Barnard’s twitter feed for this article.

This article recommends medical schools stop participating in U.S. News & World Report’s (USNWR) ‘best medical school’ survey. I would advocate for eliminating USNWR’s reports more broadly including their ranking of hospitals and medical specialties.

The medical school rankings rely on the following:

  • Federal research dollars
  • Reputation – “assessed by a survey (with an abysmal response rate) of medical school deans, department chairs, and residency program directors”
  • Ratio of full-time faculty to students
  • Students’ median scores on the Medical College Admission Test and their undergraduate grade-point averages
  • Acceptance rate 

Some excerpts:

  • “Yale and Harvard Law Schools recently announced they would no longer participate in U.S. News & World Report’s (USNWR) flawed ranking system, followed closely by additional schools. The nation’s medical schools need to follow their lead. Why? The USNWR ranking system is in direct opposition to medical schools’ goal of educating a well-trained, diverse, and culturally competent medical workforce..”
  • “It is hardly a secret among medical school deans that the USNWR rankings are based on data not directly related to educational process, quality, and outcomes. Nor can they trust the veracity of the data that are provided, given the recent scandals reported in other professional schools and colleges that manipulate the formula to their own advantage.”
  • Comprehensive analyses of USNWR rankings have long demonstrated that the methodology is ill-conceived, that the response rate of those completing the questionnaires that feed into the ranking formula would not meet the standards of a peer-reviewed publication, and that the most important aspects of educational quality are largely ignored.”
  • “There is peer pressure to stay within the system and to compete for the top prize because it feels good to see your school on top, no matter how flawed the measuring stick.”

My take: It is difficult to measure quality. I do not trust USNWR’s rankings with regard to “best” medical school, “best” hospital or “best” subspecialty. I think medical care would be better off without these reports. Another option would be to focus on reporting hard data, rather than the current aggregate format. This data could include federal research dollars and reputational surveys; the latter would need to be transparent with regard to methodology.

From The Washington Post, 11/23/22. Opinion  Americans are choosing to be alone. Here’s why we should reverse that. “Spending less time with friends is not a best practice by most standards, and it might contribute to other troubling social trends — isolation, worsening mental health (particularly among adolescents), rising aggressive behavior and violent crime. “

What To Do For Pediatric Patients with Non-Responsive Celiac Disease

AA Ibrahim et al. JPGN 2022; 75: 616-622. Budesonide and the Gluten Containing Elimination Diet as Treatments for Non-responsive Celiac Disease in Children

Background: Non-responsive celiac disease (NRCD) may affect up to 15% of children with CD. A Gluten Containing Elimination Diet (GCED) is a more stringent diet consisting of fresh, whole, and unprocessed naturally gluten-free foods (MM Leonard et al. Nutrients 2017; 9: 1129. Open Access! Indications and Use of the Gluten Contamination Elimination Diet for Patients with Non-Responsive Celiac Disease).

Methods: In this 5-year retrospective study, the authors identified 22 patients with NRCD; they were following a gluten-free diet for at least 12 months but had persistent symptoms and enteropathy (Marsh 3). Treatments for NRCD were either a GCED (n=13), budesonide (n=9) or both (n=4). Four patients were lost to follow-up and did not receive either treatment.

Key findings:

  • Thirteen were treated with the GCED for 3 months with 46% achieving both histological and symptomatic resolution
  • Nine patients were treated with budesonide (6–9 mg daily), with 89% achieving both symptomatic and histologic resolution after a median 3-month treatment course
  • 67% of patients who responded to the GCED and 100% of patients who responded to budesonide remained in remission for at least 6 months following treatment transition back to exclusive GFD

My take: This important article shows that many patients thought to be receiving a GFD can respond to a more stringent approach. In addition, it offers an alternative strategy with budesonide which had a high response rate.

Related article: PHR Green et al. Gastroenterol 2022; 163: 1461-1469. Open Access! AGA Clinical Practice Update on Management of Refractory Celiac Disease: Expert Review These recommendations are for adults with refractory celiac disease.

Best Practice Advice 1

In patients believed to have celiac disease who have persistent or recurrent symptoms or signs, the initial diagnosis of celiac disease should be confirmed by review of prior diagnostic testing, including serologies, endoscopies, and histologic findings.

Best Practice Advice 2

In patients with confirmed celiac disease with persistent or recurrent symptoms or signs (nonresponsive celiac disease), ongoing gluten ingestion should be excluded as a cause of these symptoms with serologic testing, dietitian review, and detection of immunogenic peptides in stool or urine. Esophagogastroduodenoscopy with small bowel biopsies should be performed to look for villous atrophy. If villous atrophy persists or the initial diagnosis of celiac disease was not confirmed, consider other causes of villous atrophy, including common variable immunodeficiency, autoimmune enteropathy, tropical sprue, and medication-induced enteropathy.

Best Practice Advice 3

For patients with nonresponsive celiac disease, after exclusion of gluten ingestion, perform a systematic evaluation for other potential causes of symptoms, including functional bowel disorders, microscopic colitis, pancreatic insufficiency, inflammatory bowel disease, lactose or fructose intolerance, and small intestinal bacterial overgrowth.

Best Practice Advice 4

Use flow cytometry, immunohistochemistry, and T-cell receptor rearrangement studies to distinguish between subtypes of refractory celiac disease and to exclude enteropathy-associated T-cell lymphoma. Type 1 refractory celiac disease is characterized by a normal intraepithelial lymphocyte population and type 2 is defined by the presence of an aberrant, clonal intraepithelial lymphocyte population. Consultation with an expert hematopathologist is necessary to interpret these studies.

Best Practice Advice 5

Perform small bowel imaging with capsule endoscopy and computed tomography or magnetic resonance enterography to exclude enteropathy-associated T-cell lymphoma and ulcerative jejunoileitis at initial diagnosis of type 2 refractory celiac disease.

Best Practice Advice 6

Complete a detailed nutritional assessment with investigation of micronutrient and macronutrient deficiencies in patients diagnosed with refractory celiac disease. Check albumin as an independent prognostic factor.

Best Practice Advice 7

Correct deficiencies in macro- and micronutrients using oral supplements and/or enteral support. Consider parenteral nutrition for patients with severe malnutrition due to malabsorption.

Best Practice Advice 8

Corticosteroids, most commonly open-capsule budesonide or, if unavailable, prednisone, are the medication of choice and should be used as first-line therapy in either type 1 or type 2 refractory celiac disease.

Best Practice Advice 9

Patients with refractory celiac disease require regular follow-up by a multidisciplinary team, including gastroenterologists and dietitians, to assess clinical and histologic response to therapy. Identify local experts with expertise in celiac disease to assist with management.

Best Practice Advice 10

Patients with refractory celiac disease without response to steroids may benefit from referral to a center with expertise for management or evaluation for inclusion in clinical trials.

Related blog posts:

Unrelated article: NPR (12/11/22) Authorities are urging indoor masking in major cities as the ‘tripledemic’ rages

Link: CDC Covid Weekly Tracker -lots of interesting data and information

Canyon Road Artwork in Santa Fe

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It’s Still Not Needed: Pre-op COVID Testing Prior to Endoscopy

Last year, the AGA stated that pre-endoscopy COVID testing is not needed:

This has turned out to be good advice:

A Hann et al. Gut 2022; Open Access! Impact of pre-procedural testing on SARS-CoV-2 transmission to endoscopy staff

In this retrospective study, “during a 20-month period until December 2021 using PPE and three different test approaches: no testing (n=4543), rapid antigen (RA) testing (n=682) and RT-PCR testing (n=10 465). In addition, 60 endoscopies were performed in patients with proven COVID-19. Not a single staff member became infected with SARS-CoV-2 during the 20 months analysed; vaccination rate of the team was 97%.”

The authors note that routine testing of clinical team was not performed; thus, they cannot exclude the possibility of asymptomatic infections.

My take (borrowed in part from authors): “PPE is highly effective for avoidance of SARS-CoV-2 transmission during upper or lower GI endoscopies.” Pre-op testing for COVID has many downsides: increased costs, delays in care, potential exacerbation of health disparities, and detrimental effects to endoscopy efficiency (especially with inconclusive results)

Knik River Glacier, AK

Imminent COVID-19 BA.5 Variant Booster

From Eric Topol: The imminent BA.5 vaccine booster

Key points:

  • “There are no data for a BA.5 booster in people…Each year the flu vaccine quadrivalent program is updated using mice data, so there’s certainly a precedent for using such data.”
  • “It’s actually striking that in 2 months from the June 28th FDA meeting, there is a BA.5 vaccine booster made at scale. That is finally in keeping with all the excitement about the plasticity of the mRNA vaccine platform, that it could be ideal for rapid updating.”

Covid Updates

Vaccines have been estimated to have saved more than 20 million deaths. The Lancet Infectious Diseases new release: COVID-19 vaccines are estimated to have prevented 20 million deaths worldwide in the first year of the vaccine program, modelling study find

Omicron has been associated with lower rates of MIS-C in children compared to other surges –95% less than alpha. WSJ: Covid-19 Complication Among Children Fades in Latest Wave of Virus.

Getting boosted is important for those >50 years. There was a 29-fold reduction when comparing 2 boosters vs unvaccinated and a 4-fold reduction when comparing 2nd booster vs 1 booster. CDC: Rates of COVID-19 Cases and Deaths by Vaccination Status

Partisan Divide, Misinformation and Risk of COVID-19 Death

NPR: Pro-Trump counties continue to suffer far higher COVID death tolls

Since May 2021, “those living in counties that voted 60% or higher for Trump in November 2020 had 2.26 times the death rate of those that went by the same margin for Biden. Counties with a higher share of Trump votes had even higher mortality rates…. previous polling has shown that belief in misinformation is highly correlated with being unvaccinated. Kaiser examined several common pieces of misinformation such as the idea that the government is exaggerating the severity of the pandemic, or that the vaccines contain a microchip. Kaiser’s poll found that 94% of Republicans believed one or more false statements about the vaccines.”

Related blog post: Perception of COVID-19 Risk, Vaccine Uptake and Media Source

Delusional Thinking That COVID-19 Is Over

A couple recent articles indicate a lot of reasons for concern.

First of all, it is important to recognize that even among persons less than 55 years of age, COVID-19 was the leading cause of death in 2021. Inside Medicine: Open Access: The million US Covid dead are younger than you think.

Sadly, more than 300,000 deaths in the U.S. could have been averted (NPR: This is how many lives could have been saved with COVID vaccinations in each state)

There has been a culture shift to learn to live with the virus. This is evident almost everywhere from packed restaurants, crowded venues, etc. However, there is currently high transmission and variants that are evading vaccine protection as detailed by Eric Topol, Open Access: The Covid Capitulation

Key points:

  • The United States is now in the midst of a new wave related to Omicron variants BA.2 and BA.2.12.1 with over 90,000 confirmed new cases a day and a 20% increase in hospitalizations in the past 2 weeks…The real number of cases is likely at least 500,000 per day, far greater than any of the US prior waves except Omicron.
  • “Infections…beget more cases, …Long Covid, … sickness, hospitalizations and deaths. They are also the underpinning of new variants.”
  • CDC currently is vastly underestimating the number of cases leading many towards false confidence, “feeding the myth that the pandemic is over.”
  • “As of last week, 43% of new cases were attributable to BA.2.12.1 …. BA.2.12.1 is out-competing BA.2 with its 25% higher transmission rate, which foretells its further rise to dominance across the US in the days and weeks ahead.”
  • “This family of Omicron variants with functional impact indicates more rapid evolution of the virus than what we have seen previously.”
  • There has been a “reduction in vaccine effectiveness that we are now encountering…[Protection from severe disease] has declined to approximately 80%, particularly taking account the more rapid waning than previously seen.”
  • “It’s overly optimistic to think we’ll be done when Omicron variants run their course. Not only are they providing further seeding grounds for more variants of concern, but that path is further facilitated by tens of millions of immunocompromised people around the world, multiple and massive animal reservoirs, and increased frequency of recombinants.”
  • “Vaccinated individuals accounted for … 42 per cent [of the deaths] during the Omicron wave. This is attributable to waning of protection, lack of boosters, and the diminished protection against Omicron (BA.1).”
  • What needs to be done: More boosters/vaccines (“we rank 60th in the world’s countries for boosters”) along with more medicines, and nasal vaccines which could induce mucosal immunity

My take: Unfortunately, these articles indicate that we have a long way to go. High quality masks are going to be needed at health care settings for a while. For those trying to avoid COVID-19, it will remain important to avoid large indoor gatherings. For public policy/economic policy, we need to continue to fund COVID-19 resources.

Related blog posts: