Primecuts – This Week in the Journals

April 26, 2021


By Edward T. Carey, MD

Peer Reviewed

With medicine advancing at such a rapid pace, it is crucial for physicians to keep up with the medical literature. This can quickly become an overwhelming endeavor given the sheer quantity and breadth of literature released on a daily basis. Primecuts helps you stay current by taking a shallow dive into recently released articles that should be on your radar. Our goal is for you to slow down and take a few small sips from the medical literature firehose.

 

Bariatric Surgery and Cardiovascular Outcomes in Patients With Obesity and Cardiovascular Disease  [1]  https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.120.052386

Obesity is a known risk factor for poor cardiac outcomes, and weight loss is one of the most common recommendations given in physician’s offices.[2] The authors of this paper note there have been several promising observational studies investigating the impact of bariatric surgery on cardiac outcomes[3-5]. However, this retrospective cohort study is unique in that it is a larger population-based trial investigating outcomes specifically in patients with previously known cardiac disease.

The authors took patients who underwent bariatric surgery from 2010 through 2016 and compared cardiac outcomes with similar patients who would have been eligible for but did not undergo surgery. Ultimately 1,319 surgical patients were matched to these controls. Roux-en-Y gastric bypass accounted for 80% of the procedures with the remainder being sleeve gastrectomies. Patients were similar in age (Surgery 55.4, control 56.55) and BMI (Surgery 48.05 vs Control 46.74) Notably, the non-surgical group had higher rates of prior myocardial infarction, substance abuse, and emergency department visits while trending toward lower income.  Variables, such as these, can potentially place patients at higher risk for cardiac disease in the non-surgical group potentially biasing the results.

Median follow up was approximately 4 years. Incidence of major adverse cardiac events (MACE) was 151 in the surgical group, and 259 in the non-surgical cohort. They found 11.5% of the surgical patients and 19.6% of the non-surgical patients underwent MACE. This was  a statistically significant 8.2% absolute risk reduction (NNT 12.2) for adverse cardiac events for those who underwent bariatric surgery.

This study showed bariatric surgery was associated with a lower risk of future cardiac events. However, there were significant and notable differences between the two groups in terms of socioeconomic status and prior cardiac events, which are important confounding variables and perhaps weaken conclusions drawn from this paper. However, this large study helps to confirm the benefit of bariatric surgery and weight loss on cardiac outcomes in patients with pre- existing cardiac disease.

Trial of Psilocybin versus Escitalopram for Depression https://www.nejm.org/doi/full/10.1056/NEJMoa2032994

In recent years there has been a search for depression treatments for patients who cannot take or do not respond to selective serotonin reuptake inhibitors, as well as interest in using psychedelic medications to treat psychiatric diseases. Robin Carhart-Harris et al [6] recently published a randomized, phase 2, double blind, controlled prospective trial comparing psilocybin versus escitalopram in patients with major depressive disorder in the United Kingdom.

Patients were randomly assigned to one of two groups. One received psilocybin 25 mg twice three weeks apart plus six weeks of placebo.  The escitalopram group received two 1 mg doses psilocybin with six weeks of escitalopram. They noted all patients received psilocybin but assumed the 1 mg dose the patients in the escitalopram group received was negligible. Thirty patients were randomized to the psilocybin group and 29 to the escitalopram group.  The primary outcome was the 16-item Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR-16), a 27 point scale with higher scores indicating increased depression.

The mean change from baseline QIDS-SR-16 score was 8 in the psilocybin group and 6 in the escitalopram group, a statistically significant outcome. In one of the secondary outcomes, the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS), the psilocybin group had a durable response. Notably, no serious adverse events took place.

This study may validate psilocybin as a possible treatment option for depression. However, the two-point change in a depression scale while statistically significant may not be a clinically relevant improvement. Further, it is clear that over the course of the study, as escitalopram takes effect, the curves comparing the depression score begin to converge. Further, it seemed unusual that not only did the patients in the escitalopram group received psilocybin 1 mg twice, but the authors deemed this to be negligible. Based on these issues, more research with more impressive outcomes needs to be performed before psilocybin should be considered as an alternative treatment for depression..

Cost-effectiveness of Hypertension Treatment by Pharmacists in Black Barbershops  https://www.ahajournals.org/doi/abs/10.1161/CIRCULATIONAHA.120.051683

As non-Hispanic Black men have been shown to have worse blood pressure control compared to other racial and ethnic groups [8, 9] the authors sought to evaluate a creative intervention to improve hypertension control in this group . The original project embedded pharmacists in Los Angeles County Black-owned barbershops to assist in blood pressure control for the patrons/patients, comparing that to usual care with barber-delivered blood pressure education alone. 

319 patients were enrolled in this study.  Pharmacists visited Black-owned barbershops and delivered hypertension care, including initiating and titrating medications, lab work, and telephone call follow ups.  They showed 68% of the patients in the intervention arm had a BP below 130/80, compared to only 11% in the control arm [7]. Despite clinical successes, there remained concerns about the costs and sustainability of this project [7, 10, 11]. 

In this subsequent cost-effective analysis, the authors extrapolated data after the one year of pharmacist intervention and ran a 10 year simulation to model costs and outcomes. They found a projected reduction in cardiac events in the intervention arm compared to control over the 10 year simulated period. Their simulation estimated that the intervention arm would cost approximately $2,300 more per patient than the control over 10 years. They also found it would gain a mean of 0.06 quality adjusted life years (QALYs). This amounts to about $42,000 per QALY gained. This cost fell to $17,000/ QALY when only generic drugs were used. Using a benchmark of $50,000 or $100,000/QALY they concluded that hypertension care by pharmacists at barbershops is cost-effective.  Although this is a creative and clinically effective intervention, implementation can be logistically challenging in both the short-term and long-term.    With a renewed focus on community health workers, and care outside the traditional healthcare settings, this article will hopefully lead to similarly novel and creative ways of addressing the clear healthcare inequities in our society.

COVID QUICK CUTS CORNER

Viral sequencing reveals US healthcare personnel rarely become infected with SARS-CoV-2 through patient contact https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciab281/6226897?searchresult=1

In this study[12], recently published in Clinical Infectious Diseases, the authors investigated SARS-CoV-2 infections involving 95 healthcare workers and 137 possible patient interactions. Through viral sequencing, they could not link healthcare worker infections to a patient or coworker in the majority of the patients. This suggests most healthcare workers infected with SARS-CoV-2 are infected through community spread.

SARS-CoV-2–Specific Antibodies in Breast Milk After COVID-19 Vaccination of Breastfeeding Women  https://jamanetwork.com/journals/jama/fullarticle/2778766

This article [13] described a prospective cohort study investigating breastfeeding women who received COVID-19 vaccination in Israel. They found 91% of breast milk samples showed IGG against COVID-19 4 weeks after vaccination, and no mother or infant had serious adverse events during the study period. This shows that COVID-19 vaccination for lactating mothers may extend protection to their children.

Antibody Persistence through 6 Months after the Second Dose of mRNA-1273 Vaccine for Covid-19  https://www.nejm.org/doi/full/10.1056/NEJMc2103916?query=featured_coronavirus

There has been recent discussion [14]that after recent COVID vaccination, booster immunizations may be needed. This is an important question to answer for personal and public health, as well as for government and stakeholders. In this paper, Nicole Doria-Rose et al [15], investigate this problem through patients who received the Moderna mRNA 1273 vaccine. In patients 6 months after their second dose of the vaccine, antibody activity remained high in all groups. They noted using a live virus neutralization test, all patients had detectable activity. They noted older patients had lower immune activity. Overall, this study indicates that the immune response to the Moderna mRNA vaccine is durable and may not require a booster. Further work on this important topic is certainly needed.

Dr. Edward T. Carey is a 2nd year resident at NYU Langone Health

Peer reviewed by Neil Shapiro, MD, Editor-in-Chief, Clinical Correlations

Image courtesy of Nasa.gov

References

  1. Doumouras, A.G., et al., Bariatric Surgery and Cardiovascular Outcomes in Patients With Obesity and Cardiovascular Disease:: A Population-Based Retrospective Cohort Study. Circulation, 2021. 143(15): p. 1468-1480.
  2. Van Gaal, L.F., I.L. Mertens, and C.E. De Block, Mechanisms linking obesity with cardiovascular disease. Nature, 2006. 444(7121): p. 875-80.
  3. Fisher, D.P., et al., Association Between Bariatric Surgery and Macrovascular Disease Outcomes in Patients With Type 2 Diabetes and Severe Obesity. JAMA, 2018. 320(15): p. 1570-1582.
  4. Sjostrom, L., et al., Association of bariatric surgery with long-term remission of type 2 diabetes and with microvascular and macrovascular complications. JAMA, 2014. 311(22): p. 2297-304.
  5. Aminian, A., et al., Association of Metabolic Surgery With Major Adverse Cardiovascular Outcomes in Patients With Type 2 Diabetes and Obesity. JAMA, 2019.
  6. Carhart-Harris, R., et al., Trial of Psilocybin versus Escitalopram for Depression. New England Journal of Medicine, 2021. 384(15): p. 1402-1411.
  7. Bryant, K.B., et al., Cost-effectiveness of Hypertension Treatment by Pharmacists in Black Barbershops. Circulation, 2021.
  8. Foti, K., et al., Hypertension Awareness, Treatment, and Control in US Adults: Trends in the Hypertension Control Cascade by Population Subgroup (National Health and Nutrition Examination Survey, 1999-2016). Am J Epidemiol, 2019. 188(12): p. 2165-2174.
  9. Clark, D., 3rd, et al., Population-Attributable Risk for Cardiovascular Disease Associated With Hypertension in Black Adults. JAMA Cardiol, 2019. 4(12): p. 1194-1202.
  10. Ferdinand, K.C. and R.M. Graham, Uncontrolled Hypertension in Black Men. Circulation, 2019. 139(1): p. 20-23.
  11. Margolis, K.L., Inventing a New Model of Hypertension Care for Black Men. N Engl J Med, 2018. 378(14): p. 1345-1347.
  12. Braun, K.M., et al., Viral sequencing reveals US healthcare personnel rarely become infected with SARS-CoV-2 through patient contact. Clin Infect Dis, 2021.
  13. Perl, S.H., et al., SARS-CoV-2-Specific Antibodies in Breast Milk After COVID-19 Vaccination of Breastfeeding Women. JAMA, 2021.
  14. Stieg, C. Dr. Fauci: ‘We very well may need to get booster shots’ for Covid — here’s when. CNBC, 2021.
  15. Doria-Rose, N., et al., Antibody Persistence through 6 Months after the Second Dose of mRNA-1273 Vaccine for Covid-19. N Engl J Med, 2021.

 

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