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Coronavirus Disease 2019 Vaccine

Coronavirus disease 2019 (Covid-19) has been declared a pandemic by the world health organization (WHO) on March 11, 2020. Since the outbreak, the WHO reported more than 70 million confirmed cases, and 1.5 million deaths globally. In the US, nearly 300,000 lost their lives and currently, we are facing another surge of cases with a record-breaking 3,124 new deaths in a single day last week. Over the past year, scientists, physicians, and pharmaceutical companies did phenomenal efforts to develop a safe and effective vaccine.

Finally, on December 11 2020, The Food and Drug Administration has issued an emergency use authorization (EUA) for Pfizer and BioNTech’s coronavirus vaccine (based on a 17 to 4 vote with one abstention). It is important to note that an EUA is not equivalent to FDA approval. As the latter requires safety data for at least six months. The FDA clearance occurred in a record-breaking time frame for a complicated process that usually takes years. This EUA makes the United States the sixth country to clear the vaccine after Bahrain, Canada, Saudi Arabia, Mexico, and the United Kingdom. In this blog, I will review the data behind the EUA.

The study behind the FDA’s EUA was a multinational, phase 2/3, Placebo-controlled, observer-blinded randomized trial. Between July 2020, and November 2020, 43,548 participants (16 years and older) who were healthy or had stable medical conditions underwent 1:1 randomization to receive vaccine or placebo (saline). Of which, 36,523 received two doses (21 days apart) and completed the 2 months follow up. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among the vaccine group and 162 cases among the placebo group. Hence the vaccine was 95% effective in preventing Covid-19. Moreover, among the 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in the placebo group and 1 in the vaccine group.

Figure 1: Efficacy of the vaccine against Covid-19 after the First Dose.

Each symbol represents Covid-19 cases starting on a given day; filled symbols represent severe Covid-19 cases. The inset shows the same data on an enlarged y-axis, through 21 days.

The noted side effects were short-term mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and similar in both groups (0.6% in the vaccine group and 0.5% in the placebo group).

Figure 2: Safety outcomes of the vaccine.

The Vaccine works simply as it contains a small piece of the virus’s mRNA that instructs cells in the body to produce the virus’s distinctive “spike” protein. After receiving the vaccine, the body will manufacture a piece of the COVID-19 virus named spike protein, which does not cause disease but triggers the immune system to learn to react defensively. Given the novel mechanism, theoretically, it carries no risk of infection, as it only codes for a piece of the virus. It is also important to note that currently, it is unclear how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person.

Given the promising results and the EUA, Pfizer is planning on shipping 2.9 million doses over this week and 100 million doses of the vaccine by next March. The pharmaceutical giant has a deal with the U.S. government, under that agreement, the vaccines will be free to the public. Understandably, the distribution will be in phases with the most critical workers and vulnerable people being on top of the list. At this point, strict monitoring of any side effects will be enforced at all sites. Apart from the approved vaccine, Moderna’s vaccine utilized a similar technology and is currently under review by the FDA and could obtain an EUA soon. Other pharmaceutical companies such as Johnson & Johnson, Oxford, and AstraZeneca, are in late-stage trials and their vaccines could be authorized in the near future. This Vaccine is the light at the end of the tunnel which gives humanity hope to reach an endpoint to this pandemic. In the meantime, we must practice social distancing, trust the data, and get vaccinated!

“The views, opinions and positions expressed within this blog are those of the author(s) alone and do not represent those of the American Heart Association. The accuracy, completeness and validity of any statements made within this article are not guaranteed. We accept no liability for any errors, omissions or representations. The copyright of this content belongs to the author and any liability with regards to infringement of intellectual property rights remains with them. The Early Career Voice blog is not intended to provide medical advice or treatment. Only your healthcare provider can provide that. The American Heart Association recommends that you consult your healthcare provider regarding your personal health matters. If you think you are having a heart attack, stroke or another emergency, please call 911 immediately.”

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Let’s Ban the Phrase “Social Issues”: Social Justice and Advanced Heart Failure Therapies

Everyone on our unit seems to know Tina. Tina is a 50-year-old Black woman. She is single, has two kids and does not have stable housing, currently living with an abusive man in one of the poorest neighborhoods in Baltimore. She has nonischemic cardiomyopathy and has been admitted numerous times to the inpatient Cardiology service.

Each time, she is admitted for acute decompensated heart failure, diuresis aggressively to euvolemia, and discharged. She has not “tolerated” previous attempts to start guideline-directed medical therapy (GDMT), so the only heart failure medication she takes at home is an oral diuretic. “Behavioral issues” are flagged all over her chart: she has left against medical advice, has demonstrated “poor insight” into her medical condition, and has refused medications and treatments.

This admission is no different. When I first meet her, she is teetering on cardiogenic shock, twenty pounds above her dry weight, dry heaving and confused, her extremities cool. She quickly turns around with inotropic support and diuretics and is now doing a lot better. I’ve managed to convince the team to re-trial GDMT and we have her on a low-dose ACE inhibitor and spironolactone. The nurses on our floor have also taken a liking to her and have banded together to help care for her on her own terms. Tina is doing all of the things we are asking of her.

But what will the future look like for Tina? She has entered that unfortunate spiral in which all patients with advanced heart failure find themselves: recurrent and increasingly frequent hospitalizations, progressive decline, and seemingly no way out. One day on rounds, we discuss her options. A member of our team mentions offhand that she is obviously not a candidate for advanced therapies due to her “social issues” and her lack of adherence to prescribed therapies.

Every time I hear the words “social issues” in the hospital, I shudder and think about how loaded the phrase is. It’s a catch-all euphemism that physicians use to describe patients who face obstacles extending beyond their medical environment and into their social or contextual environment. These patients, like Tina, share certain characteristics: they are female, Black or brown, poor and live in socioeconomically deprived neighborhoods. Moreover, these patients with “social issues” do not qualify for advanced heart failure therapies such as left ventricular assist devices (LVADs) and heart transplants.

Indeed, this trend is supported by the medical literature. A recent study published in Circulation: Cardiovascular Quality and Outcomes found that women, Black patients, Latinx patients, Medicare and Medicaid patients, and those living in lower-income areas were less likely to receive LVADs than their more privileged white, male, insured counterparts living in higher-income areas.1 Likewise, another recent study published in Circulation found that a patient’s race influenced decision-making around selection for a heart transplant.2 Disparities also extend to outcomes related to these advanced therapies, as highlighted by a Circulation: Heart Failure study that found socioeconomic and racial disparities in outcomes after a heart transplant.3

In the face of such evidence, we must challenge the status quo on behalf of our patients with “social issues.” We must question the presumption that they are simply ineligible for advanced heart failure therapies. We must investigate the role that personal, social, and contextual factors have played in bringing them to the precipice of death from end-stage heart failure. We must ask ourselves how their lifelong experiences with racism and discrimination in the hands of healthcare providers affect their trust in us. We must ask ourselves which societal forces of socioeconomic oppression and structural racism make it difficult for them to obtain the care they need to live a better life. And finally, we must look inward and acknowledge the ways in which we as health care providers perpetuate racism and discrimination against them through our own words, discussions, and actions.

Most importantly, we must figure out how to right this injustice, so that we do not just take it for granted that patients like Tina cannot access LVADs and heart transplants. We need to determine what we must do to help these patients receive the same advanced interventions that their privileged contemporaries are offered.  Everyone should have equal access to these therapies; our work as cardiologists, physicians and good citizens of our society is not done until the words “social issues” are banned from our lexicon and are no longer used to disqualify patients from receiving life-saving therapies.

References:

  1. Wang X, Luke AA, Vader JM, Maddox TM, Joynt Maddox KE. Disparities and Impact of Medicaid Expansion on Left Ventricular Assist Device Implantation and Outcomes. Circulation. Cardiovascular quality and outcomes. 2020;13(6):e006284.
  2. Kuehn BM. Race May Influence Transplant Decision Making in Heart Failure: Studies Also Detail Disparities in Hypertension Diagnosis, Statin Prescribing. Circulation. 2020;141(8):694-695.
  3. Wayda B, Clemons A, Givens RC, et al. Socioeconomic Disparities in Adherence and Outcomes After Heart Transplant: A UNOS (United Network for Organ Sharing) Registry Analysis. Circulation. Heart failure. 2018;11(3):e004173.

“The views, opinions and positions expressed within this blog are those of the author(s) alone and do not represent those of the American Heart Association. The accuracy, completeness and validity of any statements made within this article are not guaranteed. We accept no liability for any errors, omissions or representations. The copyright of this content belongs to the author and any liability with regards to infringement of intellectual property rights remains with them. The Early Career Voice blog is not intended to provide medical advice or treatment. Only your healthcare provider can provide that. The American Heart Association recommends that you consult your healthcare provider regarding your personal health matters. If you think you are having a heart attack, stroke or another emergency, please call 911 immediately.”

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Smallpox to COVID-19: We’ve come a long way!

The history of humankind has never witnessed an infectious agent deadlier than Smallpox. It is thought to have first appeared in Asia or Africa thousands of years ago, before spreading to the rest of the world. This virulent disease was causing hundreds of thousands of deaths each year during the 16th, 17th, and 18th centuries in Europe alone; and when Europeans brought it to Mexico in the 16th century, it killed nearly half of the previously unexposed Aztec and Inca population in less than 6 months.1,2 In the early 1700s, Lady Mary Montague, the wife of the British Ambassador to Turkey, and a disfigured Smallpox survivor, was fascinated by the smooth skin of the ladies at the famous Turkish Baths. A face with no scars was a rare sight in Smallpox-devastated England at the time. “The small-pox, so fatal, and so general amongst us, is here entirely harmless, by the invention of engrafting”, she wrote home in her notable letter.3 She had witnessed the primitive form of vaccination, which was then called inoculation. Turkish mothers would gather their children at Smallpox parties, where an old lady would tear the skin of healthy kids and smear a small sample of the virus (typically from a recently infected child). The kids would then develop a mild form of illness that recovers with no scarring and gives them long term immunity. Lady Montague used this technique to protect her son and has been credited for bringing this historical discovery back to England and advocating for its widespread use despite major opposition from the British medical community at the time (Figure 1). Subsequently, in 1796, Edward Jenner developed the much safer technique of vaccination using Cowpox instead of the Smallpox virus.4 Two centuries later, Smallpox was completely eradicated!

Figure 1: The painting Lady Mary Wortley Montagu with her son, Edward Wortley Montagu, and attendants attributed to Jean Baptiste Vanmour (oil on canvas, circa 1717). © National Portrait Gallery, London: NPG 3924.

What is most remarkable about this story is that the practice of Smallpox inoculation was introduced in Europe only in 1721 by the relentless efforts of a concerned and enlightened mother, despite being successfully used in Oriental countries such as China, India, and Turkey for centuries. In other words, one half of the globe was deeply suffering from an illness that killed millions of people over the years, while the other half held the secret to its prevention. And it was only when knowledge was exchanged between the two halves that humanity finally defeated one of its deadliest historical enemies! There has never been a better moment to relive and celebrate the magnificent product of worldly human collaboration than these days, as people around the globe started receiving their first doses of COVID-19 vaccines. A deadly virus that took the world by surprise and killed more than 1.5 million people, now, only a year later, has more than one vaccine with proven efficacy. It is amazing how far we have come along since the times of Smallpox! The obvious difference is the power of science and research, yet, another big and equally important difference, is how well connected our world is right now. This unprecedented connection is what allowed us to have a global response to this pandemic and unite our efforts to create a solution (Figure 2). Two Turkish immigrants develop a technology in the labs of a Germany-based biotech company to be quickly adopted by an American Pharmaceutical giant, which tests it and subsequently mounts a large-scale distribution process around the world —among other fascinating stories. As much as we seem deeply divided nowadays, due to political and ideological differences, in fact, over the history of humankind, there has never been a time where the world population was more united! Maybe we clearly see our major differences simply because we have never been this close! And our closeness and continued collaboration are what will get us through this! It is too early to declare victory, and things are far from perfect, but it’s a good time to pause and appreciate our progress!

Figure 2: The global effort for COVID-19 vaccine development.
Image credit: Judith Kulich, Cody Powers, Amit Pangasa, Kristyn Feldman, Parul Rewari and Samaya Krishnan. COVID-19 vaccines: Who might win the race to the global market? Published May 13, 2020. Available online on: https://www.zs.com/insights/covid-19-vaccines-who-might-win-the-race-to-the-global-market

References:

  1. Hopkins DR. The greatest killer: smallpox in history. vol. 793. University of Chicago Press; 2002.
  2. Razzell P. The conquest of smallpox: the impact of inoculation on smallpox mortality in eighteenth century Britain. Caliban Books, 13 The Dock, Firle, Sussex BN8 6NY; 1977.
  3. Lady Mary Wortley Montagu, “Lady Mary Wortley Montagu on Small Pox in Turkey [Letter],” in Children and Youth in History, Item #157. Available online: https://chnm.gmu.edu/cyh/items/show/157 (accessed December 27, 2020). Annotated by Lynda Payne
  4. Lindemann, Mary. Medicine and Society in Early Modern Europe. Cambridge University Press. p. 77. ISBN 978-0521732567; 2013.

“The views, opinions and positions expressed within this blog are those of the author(s) alone and do not represent those of the American Heart Association. The accuracy, completeness and validity of any statements made within this article are not guaranteed. We accept no liability for any errors, omissions or representations. The copyright of this content belongs to the author and any liability with regards to infringement of intellectual property rights remains with them. The Early Career Voice blog is not intended to provide medical advice or treatment. Only your healthcare provider can provide that. The American Heart Association recommends that you consult your healthcare provider regarding your personal health matters. If you think you are having a heart attack, stroke or another emergency, please call 911 immediately.”

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Wellness Amid a Pandemic

I think about wellness often and the unique aspects of being a physician that make preserving our wellbeing even more important. Of course, this COVID-19 pandemic has tested all of us and the things we turn to for wellness and our escape from medicine, may not be available to us right now. After work dinner and drinks, early morning group fitness classes, and young professional networking events have been replaced by Netlfix© and dine-in, home workouts, and Zoom “wine” downs. We all had to dig down deep inside to find new venues for wellness and if we were lucky, our institutions provided resources to help us during this crazy time. What this pandemic taught me was that there are things I still needed to work on to build my resilience even further- and I am totally okay with that. Working on ourselves to better ourselves should be a continuous goal- everyone has room for improvement.

As a single woman living in the city, my nights and weekends were always filled with social events. I felt very isolated and realized how much of my free time was being occupied by my friends and the events I attended as part of my wellness routines. I miss my morning classes at bootcamp and will never complain again when my alarm wakes me up at 4:25am to get to class- whenever that may be. Some of the things that have helped me are FaceTime and Houseparty dates with friends and family, walking outside on the few sunny days Boston has graced us with, trying to eat healthy when I can, in-home workouts which I am not a fan of to be completely honest, but most important, was being vulnerable with friends, family, colleagues, and even patients who asked how I was doing during our virtual visits. I met with a Wellness Coach provided through my institution and the lightbulb moment for me was when he reminded me to be kind to myself. I remember seeing posts all over social media about how we should be building businesses, getting in shape, writing grants, or checking off any other number of “goals” because we have “so much time” and feeling bad, but I got over that. In the middle of this crisis, all our lives have been disrupted, some much more so than others, and we are all doing the absolute best we can. I remind myself to be grateful and I started writing specific things down that I am grateful for each day.

May is Mental Health Awareness Month and as physicians, we shy away from talking about such things. It may be that we are supposed to be superheroes who are invincible, or it may be that if we did seek help and received a diagnosis we would have to declare it on some medical state licensing applications, or we may just be afraid. Mental health is one of the many aspects of overall wellbeing and there are many ways to reach out for help for those who need it. COVID-19 has had many casualties and we must guard our mental health during this pandemic. Find what works for you and do it. Reach out when you need to and remember that it is totally okay to not be okay. Protect your mind, body, and soul as these are key aspects of our overall wellbeing. I feel optimistic about our future. When we come out on the other side of this let us take all the lessons we learned and remember to never take things such as human contact for granted again.

Stay safe and stay healthy.

“The views, opinions and positions expressed within this blog are those of the author(s) alone and do not represent those of the American Heart Association. The accuracy, completeness and validity of any statements made within this article are not guaranteed. We accept no liability for any errors, omissions or representations. The copyright of this content belongs to the author and any liability with regards to infringement of intellectual property rights remains with them. The Early Career Voice blog is not intended to provide medical advice or treatment. Only your healthcare provider can provide that. The American Heart Association recommends that you consult your healthcare provider regarding your personal health matters. If you think you are having a heart attack, stroke or another emergency, please call 911 immediately.”

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Conferences in the Time of COVID

As with pretty much everything else, conference season is going to look a lot different from last year due to COVID-19. Conferences have already switched gears to go completely virtual to meet this challenge but still give scientists the opportunity to share their work with the world. Initially, I was a little bummed about the need to switch meetings to a virtual format — but I then realized that there are also some really great advantages to this situation.

As a new mother, I had already resigned myself that I wouldn’t really be able to participate much in conferences this year, but now that has completely changed. I’m actually going to attend three meetings, including the AHA BCVS conference in July, which I am really excited about. While it would be great to see everyone in person and I know that it won’t completely be the same without the social interactions many of us look forward to, the virtual format provides science opportunities to many that otherwise would have missed out. It’s important in this strange time to celebrate the positives. To get more insight on how to make the best of a virtual meeting, check out fellow blogger Shayan Mohammadmoradi’s latest piece — it’s filled with great tips!

In addition to conferences going virtual, seminars at universities and professional organizations have done the same thing. Once it was apparent that COVID-19 was changing the face of the world, The International Society for Heart Research quickly organized a virtual seminar series that has been keeping researchers from all over the world updated on the latest science. Check out the schedule here to attend any meeting you want via zoom from your home!

If you are planning a meeting, going completely virtual may seem like a daunting task, but since so many have started to work out the kinks to the online format, it’s becoming easier to find resources to help you make the event a success. Additionally, before COVID-19 took hold, many scientists were already pushing the community to move to a virtual system to combat climate change, so this switch may have been inevitable. Online meetings can be just as enriching as the in-person events that we are used to — we just have to keep an open mind.

“The views, opinions and positions expressed within this blog are those of the author(s) alone and do not represent those of the American Heart Association. The accuracy, completeness and validity of any statements made within this article are not guaranteed. We accept no liability for any errors, omissions or representations. The copyright of this content belongs to the author and any liability with regards to infringement of intellectual property rights remains with them. The Early Career Voice blog is not intended to provide medical advice or treatment. Only your healthcare provider can provide that. The American Heart Association recommends that you consult your healthcare provider regarding your personal health matters. If you think you are having a heart attack, stroke or another emergency, please call 911 immediately.”

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Fifth Year at Vascular Discovery: How an Early Career Navigates Through a Virtual Event

It is not news anymore that after World Health Organization (WHO) classified novel coronavirus disease (COVID-19) as a pandemic, the real-life impact of the “new normal” started to show itself. We started to see the impact by pausing the research and of course, cancelation of all scientific events. As scientists shifted their focus toward the data analysis, manuscript preparation, grants or any other means of remote work, the American Heart Association also shifted its focus to keep events happening, virtually. This new mode of attending a conference has many perks including petting your dog when the field’s connoisseur is giving a talk, drinking coffee from your favorite mug, or keeping the PJs on. However, there is a trade-off. Navigating through a professional event such as #VascularDisovery20 is challenging by itself, let alone going after it when you are not physically present. The following tips will help you to turn this year into a great opportunity.

1: Networking with Peers and Mentors: Online Presence

Now that there is no opportunity to join a table for lunch, mingle during the dinner event or grab a coffee with your colleagues from other countries, increase your online presence by interacting with attendees on Twitter. Use the chat mode during virtual sessions to ask questions or chat with others. If you have a burning question about a talk, either tweet at the presenter or email them. This is a great practice for increasing your “professional” online activity.

2: Utilize the Home Stay

Now that you have a desk in front of you instead of sitting on conference room chairs (which are really uncomfortable from time to time), take notes with ease, have your screen open with relevant papers to the talk, take high-quality images from the slides you find important and download the available contents in advance from the #HeartHub. In addition, you can now have a comprehensive look at your favorite posters and get connected with the presenters.

3: Plan Ahead

Although you may think that you can easily jump to the laptop and login to the talk that is “live”, the reality may be different. There are still concurrent sessions that you need to choose which one you attend. Also, there is always a possibility of a technical problem, so make sure that everything is set and you know exactly which talk you are going after. Also, pay attention to the time-zone listed in the schedule.

4: Hangouts at Conference Evenings: Say Hello to Face Time or Zoom

It is an unwritten tradition that many attendees get together after a long day of scientific endeavors to sit down, chit chat and grab a drink. Use the ATVB Journal virtual happy hour with EIC Dr. Alan Daugherty as an example. If you would like to hang out with the “conference buddies”, reach out to them, set up a private virtual meeting and catch up. This is a great practice to break those shyness barriers, especially if you are at the early career stage.

It is obvious that nothing compares to be physically present among your peers, colleagues and mentors. However, during these uncertain times, we can still manage to make the most out of the opportunities we are offered. As scientists, we are always learning to overcome new challenges and come up with new solutions, therefore, navigating through a virtual event not only is a fun challenge but also is a great learning experience with many opportunities.

“The views, opinions and positions expressed within this blog are those of the author(s) alone and do not represent those of the American Heart Association. The accuracy, completeness and validity of any statements made within this article are not guaranteed. We accept no liability for any errors, omissions or representations. The copyright of this content belongs to the author and any liability with regards to infringement of intellectual property rights remains with them. The Early Career Voice blog is not intended to provide medical advice or treatment. Only your healthcare provider can provide that. The American Heart Association recommends that you consult your healthcare provider regarding your personal health matters. If you think you are having a heart attack, stroke or another emergency, please call 911 immediately.”

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In defense of peer review

The generation of knowledge, through rigorous, established systematic methods has informed much of our progress in the past few centuries. Science guides all aspects of healthcare today including how we develop the new medications, therapeutic procedures, and non-pharmacological interventions that have improved the quality and duration of human life. Many of the crucial gates in the scientific journey- funding, ethical approval, and dissemination- are guarded by the process of peer review; a process that is increasing under attack in our current hyper-reactive, digital, media cycle.

Peer review is the critical appraisal of a scientific work by those who have requisite knowledge to evaluate one or more aspects of the work. It is a panel of experts in the related field who understand the importance and novelty of the questions under consideration and the rigor and trustworthiness of the methods proposed or employed to answer that question.

Peer review takes time. Time to find agreeable reviewers with the right expertise, time to review and think about the science, and time to determine how to weigh those critiques against the community’s need for information. From the early days of the novel coronavirus pandemic, this balance of time needed for peer review and unquenchable public thirst for rigorous information has been dominating the conversations at leading medical and scientific journals around the world. To better understand how these decisions are made and what we as clinicians, scientists, and health care consumers need to consider when reading and sharing emerging science, I spoke with Dr. Joseph Hill, the Editor in Chief of Circulation one of 12 AHA Journals.

Even though peer review is an established practice, it is important to start by questioning why we should even do it. Unquestionably, the value of thoughtful peer review is that it enhances the quality of the science. “We [the AHA journals)\] handle approximately 20,000 manuscripts a year and with extraordinarily rare exceptions, the paper always gets better with peer review”.

Having now published many of my own scientific manuscripts, I know the pain of peer review well. “They” missed that detail on line 176. “They” clearly lack the expertise to evaluate my work. “They” kept this manuscript for 8 months before sending their disposition! However, I also know that some of the best revisions to my papers have come from generous peer reviewers. Reviewers who volunteered to spend their time reading my papers and think deeply about my findings in the context of larger literature. While painful, the constant assessment and evaluation of our science is critical to improving the quality and impact of our work.

Prior to the coronavirus outbreak, up to 10 experts, including peer reviewers, statisticians, and editors, would review a manuscript for Circulation. But the need for up-to-date information about the epidemiology, pathophysiology, and treatment of COVID-19 challenged Circulation’s editorial team to move fast. While recognizing that it’s “hard to do good science in a war zone”, the quality of published science cannot be compromised in times of crisis. Dr. Hill continues, “We are walking a fine line between trying to get the information out as quickly as possible but we recognize that [in clinical science] we could make it worse and could do harm. So we have to maintain our high standards but function at a high velocity.”

High velocity seems an understatement. After an initial call for high-quality COVID-19 related papers, the editorial team has done over 300 fast track reviews, contributed to a curated coronavirus and cardiovascular disease collection, and conducted 17 interviews with experts working on the front line around the world. All in the past month. This work is exhausting but done with great energy by a team inspired to advance “cardiovascular science for the good of humanity, especially during these times of urgent challenge, anxiety, and forthright resolve.”

Peer review is the best process we have for evaluating science; but peer review is done by peers- busy, human, distractible peers- who will make mistakes. This is why many reputable journals require an editorial screen and at least two peer reviews before it can make a decision on a manuscript. Scientific volunteers do this work. Which brings us to what you, as an early career professional can do. Peer review relies on us—all of us—to sign up to review, accept the invitation to review, and spend the time carefully doing the review. You may wonder if you have the expertise to peer review for Circulation or another AHA Journal; you likely do and you should. Dr. Hill remarked that “some of the best reviews I’ve seen are from early-career scientists”.  If you are interested in helping to contribute to peer review and the sharing of good cardiovascular science, considering signing up to be a journal reviewer in your AHA Science Volunteer Form or emailing Dr. Hill your interest in reviewing for Circulation.

 

“The views, opinions and positions expressed within this blog are those of the author(s) alone and do not represent those of the American Heart Association. The accuracy, completeness and validity of any statements made within this article are not guaranteed. We accept no liability for any errors, omissions or representations. The copyright of this content belongs to the author and any liability with regards to infringement of intellectual property rights remains with them. The Early Career Voice blog is not intended to provide medical advice or treatment. Only your healthcare provider can provide that. The American Heart Association recommends that you consult your healthcare provider regarding your personal health matters. If you think you are having a heart attack, stroke or another emergency, please call 911 immediately.”

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The Health Costs of Hunger

I hope someday we will be able to proclaim that we have banished hunger in the United States, and that we’ve been able to bring nutrition and health to the whole world. –Senator George McGovern

Food. Nothing is more basic to our existence than eating. However, in our modern era of plenty, we often take the presence of food for granted. That is, we take it for granted until we no longer have access to it or it makes us sick.

Food insecurity, when individuals lack access to adequate and safe food due to limited resources, is pervasive in the United States. In 2018, 37.2 million Americans were food insecure and of that, 6 million were children. A recent analysis found that 20-50% of college students were food insecure and hunger affects their ability to learn, be economically stable, and navigate social situations. While food insecurity tends to be higher in rural areas, it affects people of every gender, age, race and ethnicity throughout the United States.

The health consequences of food insecurity are well-described and have a disproportionate impact on cardiovascular health. In children, food insecurity is associated with birth defects, cognitive and behavioral problems, increased rates of asthma, depression, suicide ideation, and an increased risk of hospitalization.  In adults, food insecurity is linked to mental health problems, diabetes, high blood pressure, and high cholesterol. Food insecurity affects health in multiple ways (Figure 1). Conceived of as a cyclical process (in which people have periods fluctuating between food adequacy and inadequacy), fewer dietary options lead to increased consumption of cheap, energy dense, but nutritionally poor foods. Over-consumption of these foods during periods of food adequacy can lead to weight gain and high blood sugar, and reduced consumption of food during food shortages can lead to weight loss and low blood sugar. These cycles are exacerbated by stress and result in obesity, high blood pressure, and ultimately diabetes and coronary artery disease. The cycle continues until access to adequate, safe, high-nutrition foods stabilizes.

As a driver of poor nutritional intake, food insecurity is among the leading causes of chronic disease-related morbidity. As such, there is increasing recognition that for many food insecurity is not behavioral challenge but a structural one. Indeed this is the reason for the creation and continued re-authorization of the supplemental nutritional assistance program (or SNAP) that in 2018 provided $60.8 billion to more than 40 million Americans. SNAP was initially conceived during the Great Depression as a strategy to stave off mass starvation while providing American farmers with a fair price for their surplus agricultural products. It has gone through many legislative and administrative updates since the 1930’s (for a full history, please see Dr. Marion Nestle’s recent review in the American Journal of Public Health) and today remains the 3rd largest, and one of the most effective anti-hunger programs in the United States. Yet, despite its success at reducing food insecurity, today, proposals to reduce the monthly benefit levels and impose restrictions to limit access to SNAP are gaining political traction.  If the proposed SNAP reforms were enacted, 2.2 million American households would no longer be eligible for SNAP and an additional 3.1 million households would receive reduced benefits–many of those affected would be elderly and disabled. Thus, the cycle of food insecurity and chronic disease would worsen.

Food nourishes us and provides the sustenance we need to get through each day with our health, livelihood, and dignity intact.  While I have outlined the public health case for mitigating food insecurity; it is clear that food insecurity is not just a health issue, or even just a political issue. Above all else, it is a moral issue and one that we that we cannot be on the fence on. We must decide if today, in the richest country on the planet, at its most prosperous time in history, our friends, patients, and neighbors – men, women, and children who are just like us – should be hungry.

If your answer is no, then thankfully there is much that we can do about it. Check back for next month’s blog on strategies that health care providers, neighbors, citizens, and professional associations can do to help address food insecurity in America. In the meantime, please share your experiences addressing food insecurity in your own practice or community with me at @AllisonWebelPhD.

“The views, opinions and positions expressed within this blog are those of the author(s) alone and do not represent those of the American Heart Association. The accuracy, completeness and validity of any statements made within this article are not guaranteed. We accept no liability for any errors, omissions or representations. The copyright of this content belongs to the author and any liability with regards to infringement of intellectual property rights remains with them. The Early Career Voice blog is not intended to provide medical advice or treatment. Only your healthcare provider can provide that. The American Heart Association recommends that you consult your healthcare provider regarding your personal health matters. If you think you are having a heart attack, stroke or another emergency, please call 911 immediately.”

 

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Nutrition in the New Year: What is Our Role as Cardiologists?

As we embark on this new year, we are bound to field questions from our patients (and likely, family members) centered around the most popular new year’s resolution: Eating healthier. Reflecting upon my own answers to these questions in clinic over the years, I realize they have been some combination of:

“Eat smaller portions.” “Eat less meat.” “Cut out soda or juice.” “Don’t eat for 3 hours before going to bed.” “Have you heard of the Mediterranean diet?”

And the basis for my recommendations? While I’m sure my years of medical training were factored in somewhere, I feel like these suggestions were largely based on a combination of my own experiences with managing my nutrition, anecdotes from colleagues and friends, and quite possibly my favorite podcasts.

Upon further reflection, though, this is not all too surprising. For all the years that we spend in medical school, residency, and fellowship learning about pathophysiology and pharmacology, we receive much less structured education on nutrition.1 In four years of medical school, one study estimates that the average medical student receives approximately only 19 hours of didactic lectures in total on nutrition, with most of this education focusing on the manifestations of nutritional deficiencies (thiamine, vitamin C, etc.).2 If your recollection is like mine though, 19 hours seems like an overestimation, and it only declines in post-graduate medical training. In a recent study published in the American Journal of Medicine, 31% of cardiologists reported receiving no nutrition education in medical school, 59% reported none during residency, and 90% reported receiving no or minimal nutrition education during fellowship.3

Nutrition Education from Medical School to Fellowship. (From Devries et al.3)

Figure 1: Nutrition Education from Medical School to Fellowship. (From Devries et al.3)

“But we are cardiologists, not nutritionists,” one might say. Yet in the same study, 95% of cardiologists believed that their role is to provide their patients at least basic nutrition information (68.6% believed they should personally provide detailed nutrition information to patients).3 While many of our cardiovascular care teams include dieticians specifically trained to counsel our patients on their nutrition habits, we as cardiologists often find ourselves directly answering these questions from our patients.

Indeed, some physicians have made names for themselves by proselytizing specific diets for their patients. Yet what I find a bit unsettling is the variability of the messages we deliver to our patients when it comes to nutrition. While the AHA provides dietary recommendations we can share with our patients, new diets continue to pop up and gain traction in the headlines, inevitably leading to questions from our patients about whether it is safe for them to adhere to these diets. Notably, (1) intermittent fasting, (2) plant-based or vegan, and (3) ketogenic or “keto” appear to be the diets du jour.

While I personally have experimented with intermittent fasting and a plant-based diet, I am a bit uncomfortable fully endorsing one or the other to my patients, each with his or her own metabolic profile and potential list of glucose-lowering medications. When it comes to diet, more than anything, individualization is key. More so than exercise and medications, diet has deeper roots in the cultural, financial and societal environments in which our patients live. Helping them navigate a healthy lifestyle through these obstacles requires not only more time in clinic but also a deeper, more evidence-based foundation in cardiovascular nutrition.

Fortunately, we are entering an era in which we are gathering more evidence in nutrition science. A recent study published earlier this month in Cell Metabolism studied “time-restricted eating” (AKA intermittent fasting with a 10-hour eating window) in patients with metabolic syndrome,4 finding that it had beneficial effects on weight loss and metabolic profile in its albeit small sample size. (Figure 2) Additionally, a New England Journal of Medicine review article published over the holidays highlighted the existing evidence we have, both in animals and in humans, of intermittent fasting on health, longevity, and various disease states (including cardiovascular disease and cancer).5 Importantly, these recent publications and the responses they have elicited in the news and on social media have called attention to the need for more dedicated studies to address the safety and efficacy of specific diets and dietary patterns in our patients with metabolic and/or cardiovascular diseases. Indeed, more clinical trials are underway: a quick search on ClinicalTrials.gov shows that 24 registered clinical trials with an “intermittent fasting” intervention are actively recruiting participants, including the LIFE AS IF trial from the University of Chicago.

Graphical Abstract from Wilkinson et al study on Time-Restricted Eating in Metabolic Syndrome.4

Figure 2: Graphical Abstract from Wilkinson et al study on Time-Restricted Eating in Metabolic Syndrome.4

In a prior blog post on “Wearables in Medicine,” I recommended that we consider trialing wearable devices ourselves before counseling patients based on data obtained from them. While I do think our own experiences with diets and dietary patterns may be informative, our personal experiences should not be the sole pillar upon which we base our nutritional recommendations to our patients. Again, individualization is key, and a nuanced approach, factoring in living environments, medications, and metabolic profiles, is necessary.

So what should we do as members of cardiovascular care teams? Well, to provide basic nutrition recommendations to our patients, we can use the AHA Diet & Lifestyle Recommendations. However, we must acknowledge our own limitations regarding the lack of formal training on nutrition during our medical education. As such, my resolution this year is to further my education on nutritional science and attempt to understand how these popular diets may fit within modern cardiovascular disease management. To achieve these goals, I will:

  • Read: Some books recommended by my attendings that I plan to read include The Obesity Code by Jason Fung, MD and The Plant Paradox by Steven Gundry, MD. Additionally, for those interested in learning more about the role of a “keto” diet in cardiology, the ACC.org Sports and Exercise Cardiology section recently published a series of high-yield, informative articles (Link 1 and Link 2).
  • Collaborate: We have a dietician in our cardiovascular care team with whom I regrettably had not spoken directly with until recently. I previously had just referred patients to her, but I did not necessarily know exactly what advice she was giving to our shared patients. Opening and maintaining this channel of communication is essential to delivering a consistent message from our team.
  • Ask: I am now making it a habit to include a simple question in my clinic encounters: “How’s your diet?” I have found the open-endedness of the question to be quite enlightening, often helping me to uncover a new aspect of the world my patient lives in and their own perspective on how their nutrition impacts their health.

I would love to hear your input on this topic. What do you feel our roles are in nutrition counseling for our patients? What are reliable resources to learn more about this topic? How can we be better at delivering appropriate nutrition information to our patients? Please reach out to me on Twitter (@JeffHsuMD) with your thoughts and ideas.

References:

  1. Devries S, Willett W, Bonow RO. Nutrition Education in Medical School, Residency Training, and Practice. JAMA. 2019;321:1351–1352.
  2. Adams KM, Butsch WS, Kohlmeier M. The State of Nutrition Education at US Medical Schools. Journal of Biomedical Education. 2015;2015:357627.
  3. Devries S, Agatston A, Aggarwal M, Aspry KE, Esselstyn CB, Kris-Etherton P, Miller M, O’Keefe JH, Ros E, Rzeszut AK, White BA, Williams KA, Freeman AM. A Deficiency of Nutrition Education and Practice in Cardiology. Am J Med. 2017;130:1298–1305.
  4. Wilkinson MJ, Manoogian ENC, Zadourian A, Lo H, Fakhouri S, Shoghi A, Wang X, Fleischer JG, Navlakha S, Panda S, Taub PR. Ten-Hour Time-Restricted Eating Reduces Weight, Blood Pressure, and Atherogenic Lipids in Patients with Metabolic Syndrome. Cell Metab. 2020;31:92-104.e5.
  5. de Cabo R, Mattson MP. Effects of Intermittent Fasting on Health, Aging, and Disease. N Engl J Med. 2019;381:2541–2551.

The views, opinions and positions expressed within this blog are those of the author(s) alone and do not represent those of the American Heart Association. The accuracy, completeness and validity of any statements made within this article are not guaranteed. We accept no liability for any errors, omissions or representations. The copyright of this content belongs to the author and any liability with regards to infringement of intellectual property rights remains with them. The Early Career Voice blog is not intended to provide medical advice or treatment. Only your healthcare provider can provide that. The American Heart Association recommends that you consult your healthcare provider regarding your personal health matters. If you think you are having a heart attack, stroke or another emergency, please call 911 immediately.

 

 

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To Stent or not to Stent?

In the wake of the ISCHEMIA trial results being published, and the media firestorm that ensued, I’ve run into some interesting scenarios, including STEMI patients saying they don’t want to be revascularized because they heard on the news that stents are useless (oh boy!). However, after a robust discussion with an intern, I decided to do a quick n dirty rundown of who does and does not need immediate revascularization, and which strategy to go with.

If there’s one thing you should know about the ISCHEMIA trial, it is that this study sought to answer the question of whether or not STABLE ischemic heart disease would benefit from an aggressive revascularization strategy vs a conservative strategy of goal-directed medical therapy. This had nothing to do with patients who had ACS. I will also add that with long-term followup, the results might change, nobody knows for certain. The reason I say this is because the PCI arm had a signal towards harm in the first 6 months after revascularization, but as they approached 4 years, the mortality curves started to separate in favor of the aggressive revascularization arm. As it stands, their conclusions were not in favor of an aggressive strategy over a conservative one. Interestingly, these results didn’t differ very much from the COURAGE trial, where they found no significant difference between optimal medical therapy vs PCI for stable ischemic heart disease. Differences to note include the fact that COURAGE did NOT use FFR, and did not have routine use of DES.

Keep in mind, patients with left main stenosis > 50% were excluded from both of these trials, as were those who had recent revascularization within the past 6 to 12 months (PCI or CABG). The reason I mention this is because some people thought these results contradicted the findings of the COMPLETE trials – but no, these trials looked at different sets of patients altogether!

A few big wins for the ISCHEMIA trial:

  • CT-angiography was shown to be very reliable
  • FFR-guided PCI is becoming more routinely accepted as the preferred method of PCI
  • Optimal medical therapy really helps…even if there turns out to be a mortality benefit in favor of early-PCI, the fact that it takes several years to emerge is a statement about how helpful these medications truly are.

 

With regards to stable ischemic heart disease, clear indications for revascularization include left main stenosis > 50%, proximal LAD with >50% stenosis, or multi-vessel disease with signs of impaired ventricular function. Typically, cardiologists will employ the SYNTAX score, which is a validated system used to grade the severity and complexity of lesions. Typically, SYNTAX scores < 23 are amenable to PCI and non-inferior to CABG. The typical scenario for PCI is when you have isolated disease in only 1 or 2 vessels, and this is amenable to stenting.

Once you have significant left main disease, especially in conjunction with 2-3 vessel disease, the SYNTAX score is > 32, and CABG is superior.

Until very recently, it was generally accepted that isolated left main disease could be treated by PCI or CABG. However, some controversy has erupted recently after the results of the EXCEL trial were published. Specifically, the EXCEL trial had a composite endpoint of stroke, MI, or death, and there was no statistically significant differences between the two groups. Surgeons will tell you that the higher rates of the composite endpoint were driven by excess all-cause mortality in the PCI arm, as compared to peri-procedural MI in the CABG arm…in other words, while the composite endpoints were similar in both groups, the individual endpoint of mortality was higher with PCI, whereas peri-procedural MI was higher with CABG. This can certainly be a bit contentious, especially if you wonder what the clinical significance of a troponin elevation is after CABG. Nonetheless, the trial was powered to detect differences in the COMPOSITE endpoint, not in the individual endpoint of mortality.

The STICH trial demonstrated a significant benefit (albeit 10 years out) in favor of revascularization (this study only looked at CABG) for patients with ischemic heart failure. The FREEDOM trial took it one step further and tried to compare DES to CABG for mutli-vessel CAD in diabetics. The findings were strongly in favor of CABG over PCI, and this has become the accepted paradigm.

 

When you’re not sure, if they have funky looking anatomy AND they’re diabetic, you can make a safe gamble and ask your attending if they think this patient is a CABG candidate. 9 times out of 10, you’ll look like a genius.

In Conclusion:Stable ischemic heart disease has some controversy surrounding the role of revascularization, but ALL patients should be on optimal medical therapy

Patients with significantly reduced EF, Left main, proximal LAD disease, all should warrant a closer look at whether or not they would benefit from revascularization

Always try to involve a multi-disciplinary team when thinking about revascularization, at the end of the day, we are in the business of do no harm, so a second set of eyes can be beneficial.

 

The views, opinions and positions expressed within this blog are those of the author(s) alone and do not represent those of the American Heart Association. The accuracy, completeness and validity of any statements made within this article are not guaranteed. We accept no liability for any errors, omissions or representations. The copyright of this content belongs to the author and any liability with regards to infringement of intellectual property rights remains with them. The Early Career Voice blog is not intended to provide medical advice or treatment. Only your healthcare provider can provide that. The American Heart Association recommends that you consult your healthcare provider regarding your personal health matters. If you think you are having a heart attack, stroke or another emergency, please call 911 immediately.

 

References:

https://www.ischemiatrial.org/

Boden, W. E., O’rourke, R. A., Teo, K. K., Hartigan, P. M., Maron, D. J., Kostuk, W. J., … & Chaitman, B. R. (2007). Title LM, Gau G, Blaustein AS, Booth DC, Bates ER, Spertus JA, Berman DS, Mancini GB, Weintraub WS; COURAGE Trial Research Group. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med356(15), 1503-16.

Campos, C. M., van Klaveren, D., Farooq, V., Simonton, C. A., Kappetein, A. P., Sabik III, J. F., … & Serruys, P. W. (2015). Long-term forecasting and comparison of mortality in the Evaluation of the Xience Everolimus Eluting Stent vs. Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial: prospective validation of the SYNTAX Score II. European heart journal36(20), 1231-1241.

Stone, G. W., Kappetein, A. P., Sabik, J. F., Pocock, S. J., Morice, M. C., Puskas, J., … & Banning, A. (2019). Five-year outcomes after PCI or CABG for left main coronary disease. New England Journal of Medicine381(19), 1820