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Highlights provide a timely synopsis of selected interesting developments emerging in the last two weeks from the information universe covered by the PCORI Health Care Horizon Scanning System (HCHSS). Information covers currently emerging innovations in patient-centered care that may or may not be directly related to the Topics to Watch. The views presented here are solely those of ECRI Horizon Scanning and have not been vetted by other stakeholders.

The American Heart Association’s 2023 statistical update on heart disease and stroke illustrates the impact the COVID-19 pandemic has had on our nation’s heart health, both directly from illness and indirectly from delayed care. The United States saw 928,741 cardiovascular disease–related deaths in 2020, up from 874,613 the year before.

Heart disease burdens are expected to rise even more as a possible result of post-COVID conditions, as a recent US Department of Veterans Affairs study on increased risk and burden of dyslipidemia demonstrates. The continuing increase in heart disease might lead to an increased need for cardiothoracic surgery. See Topics to Watch for an approach to lowering postoperative complications.

Depression and anxiety also appear to be hallmarks of the COVID-19 pandemic. More young people died by suicide in 2020 than in previous years, suggests a study by the Center for Suicide Prevention and Research at Nationwide Children’s Hospital. Psychedelics are emerging as a novel way to approach mental health conditions and, possibly, improve lives. See Topics to Watch for one of the latest psychedelic drugs being investigated for those with depression.

Topics to Watch

ECRI Horizon Scanning has selected the topics below as those with potential for impact within the PCORI HCHSS’s focus areas in the United States within the next 3 years. All views presented are preliminary and based on readily available information at the time of writing. Because these topics are rapidly developing, we cannot guarantee the accuracy of this information after the date listed on this publication. In addition, all views expressed in the commentary section are solely those of ECRI Horizon Scanning and have not been vetted by other stakeholders. Topics are listed in alphabetical order.

N,N-Dimethyltryptamine (DMT) Fumarate (SPL026) to Treat Major Depressive Disorder

At a Glance

  • Major depressive disorder (MDD) can severely impact day-to-day activities, such as work, school, social activities, and relationships with others. In 2020, 8.4 percent of adults in the United States experienced at least one major depressive episode.
  • Several psychedelic drugs are being investigated to treat mental and behavioral health disorders, including MDD.
  • N,N-dimethyltryptamine (DMT) is a naturally occurring serotonin receptor agonist that, when taken as a drug, produces short-acting psychedelic effects. It is regulated as a schedule I drug and its use or possession by individuals in the United States is currently illegal.
  • DMT fumarate (SPL026) is a highly water-soluble preparation of DMT being investigated by Small Pharma (London, England) to treat adults with moderate to severe MDD. On January 25, 2023, the company reported that, in a phase 1/2 randomized trial, SPL026 achieved a durable, statistically significant reduction in depressive symptoms compared with placebo.
  • Though the potential cost of SPL026 is unknown, Small Pharma claims their process to manufacture the drug is efficient and low cost.

For a description and commentary about this topic/issue, download this Innovation Brief.

RBT-1 to Reduce Risk of Multiorgan Injury in Patients Undergoing Cardiothoracic Surgery

At a Glance

  • Postoperative complications from cardiothoracic surgery (e.g., coronary artery bypass graft and/or cardiac valve surgery) often include acute kidney injury (AKI), which foreshadows poor patient outcomes and complications.
  • No pharmacological therapies for preconditioning to prevent AKI are approved. Current efforts focus on preventing further deterioration of kidney function after surgery.
  • RBT-1, a combination of stannic protoporphyrin and iron sucrose, is being investigated as a pretreatment to prevent AKI. The drug is thought to induce a transient reduction in blood flow, activating cytoprotective pathways prior to cardiothoracic surgery.
  • In a phase 2, placebo-controlled trial, RBT-1 pretreatment significantly increased cytoprotective biomarkers and significantly reduced both days in the intensive care unit  and hospital readmission rates. Clinically meaningful reductions were seen in length of time patients spent on a ventilator and length of hospital stays, as well as rates of atrial fibrillation and AKI.
  • A pivotal phase 3 trial is planned for the first quarter of 2023.

For a description and commentary about this topic/issue, download this Innovation Brief.

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We welcome your comments on this Innovation Brief at [email protected].

Posted: February 24, 2023

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