Dr. Purvi Parwani is an assistant professor of medicine(cardiology) at Loma Linda University. She is a cardiac imager by training. Her clinical focus is multimodality imaging and the use of imaging for diagnosing and treating women’s cardiovascular disease and its prevention. She is the early career chair and board member of the Society for Cardiovascular Magnetic Resonance(SCMR) and social media consultant for the Journal of American College of Cardiology. She has been named cardiovascular physician to follow on Twitter twice since 2017 via different CV web agencies. @purviparwani
hidden

Being an Immigrant Doctor in the USA in Midst of the Pandemic

Purvi Parwani, MBBS, MPH

Let’s go back to 2007. Very vividly I remember my first ever conversation at a coffee shop in Ahmedabad, India (my medical school town) which had sparked interest in this land of opportunity- The United States of America (USA) -thousands of miles away from home.  A few medical students were discussing their experience of clerkship in New York. “The air is so fresh and crisp,” they said. “By the way, if a patient with severe anemia gets admitted, they don’t discharge the patient just after giving blood transfusion- they actually find the etiology”! “Wow,” I said. “That’s how I want to practice. I want to find what’s wrong with my patients”. Having memorized all the possible causes of anemia, while witnessing lots of patients get discharged with outpatient follow up predominantly due to limited resources from the largest hospital in Asia- Civil Hospital, Ahmedabad, I was excited to learn physicians get to solve the jigsaw puzzle of diagnosis and then treat the patient in the USA. After quite a bit of back and forth with my family, I decided to come to the USA. I recall the day I left India. My entire extended family had gathered to say goodbye. After all, I was the first daughter amongst many, to leave the country alone, and pursue higher education in a distant land with no family whatsoever, at the tender age of 23. I remember, seeing tears and sadness amongst my family members but I was determined and happy. “I am going to the USA to be a cardiologist”, I had announced many times as the phone in our household kept ringing to wish me luck on my journey. I literally left on cloud seven, bursting with joy, on a one-way flight to Philadelphia, on February 18th, 2008.

Fast forward April 6th, 2021. India had recorded another surge in COVID numbers that day. Two in the morning, I kept tossing and turning in my bed. Three days later, I was supposed to fly on a bubble flight to India. India had done okay with COVID in early 2021 and my parents were vaccinated. I saw a chance to see them after 1.5 years but now this covid surge out of nowhere!? All these years, I always told my family, “I am only 17 hours away. I can fly if I need to. The world is smaller than ever”. COVID had changed a lot. The entire year I had literally imagined myself hanging over the Atlantic, with the body in the US and mind and heart in India, many times. To complicate the issue, I had to renew my visa to the USA this time, to return back to the USA. “what if India goes in lockdown”, “What if I catch the new highly infectious variant prevalent in India and give it to my mother, who has been diagnosed with pulmonary fibrosis” “What if they decide to quarantine me at the airport”, “what if I don’t get my visa renewed and cannot return to the USA”. 2:30 AM, I got up, canceled my flight tickets, my visa appointment, and other arrangements. Like a giant infant then, I cried for at least half an hour. It was not fair at so many levels. Yeah, I know, that I made that choice for myself. I know I had decided to leave my family and come to the USA. After all, Life is a matter of choices and every choice you make, makes you, as John Maxwell- an American author once said.  My stay in the USA had made me what I am today, but also made me feel how I felt during that night. I often think of the contrast in my experience when I came to this country compared to now.

This pandemic has been hard on immigrant physicians. During the early days of covid, I felt like stepping in a warzone as I entered the hospital. I would recite Hanuman Chalisa (Hindu hymn chanted for strength and courage) every single day multiple times as I saw COVID patients. I often discussed with fellow immigrant cardiologists- “we cannot get sick. God forbid if we get sick, who will take care of us? Who will update our families? what if we get so sick, we cannot do our jobs and get kicked out? What if we die? How will our family manage everything while thousands of miles away? For my married friends with children at home, it was challenging. Some were sleeping separately to keep the family safe. One of my friends who is an ICU physician told me he didn’t sleep well for months during the surge. The chances of getting COVID from super sick patients were high. If he became disabled or died, his family would lose their legal status, income and would be forced to leave the country. I have a close friend who lost his mother to COVID and couldn’t see her for the last time or do the death ritual as the eldest son. During hardship, it’s easy to think of extremes. Precovid, we were part of American society, flourishing professionally, doing well. COVID changed us. The sense of security and being home in the USA eluded. Where was home?

1/3 of the physicians in the USA are immigrants1. More than a third of those IMG (International Medical Graduates) have visa restrictions in spite of legally residing in the country and paying taxes as a US citizen. The top three countries that send IMGs to the USA are India, China, and the Philippines2. For those of you who think, immigrant physicians, take up opportunities from physicians that were born in the USA, the Association of American Medical Colleges projects a shortage of up to 139,000 physicians in the US by 20333. The jobs that offer visas often take advantage of the need for visas by foreign physicians by offering little compensation for a lot more work mostly in distant parts of the country. Professional and personal uncertainty posed by the pandemic has changed the future for many immigrants particularly the physicians having witnessed the surges of covid during the peak of the pandemic before vaccination started5.

I really hope in midst of an ongoing pandemic with no sight of the end, the immigration reform gives more flexibility to the physicians to travel to their home countries without the need for visa renewal. I also hope that this land of opportunity accelerates the permanent resident status for highly skilled physicians particularly those who are on the front lines during the pandemic and served their adopted country with vigor and in certain cases with their lives.

I don’t know how the COVID pandemic is going to change immigration patterns across the world. I often think about this, now being away from family for more than a year. This country has made me who I am today, and I am so incredibly grateful for my stay in the USA, for the education, incredible career opportunities, social status, and freedom I have acquired, particularly as a female cardiologist. However, I often wonder, if all the sacrifices that I have made are worth these successes. I guess the grass is always greener on the other side, but this pandemic has definitely made me pause and reflect on my choices and decisions.

 

References:

1  https://www.newamericaneconomy.org/issues/healthcare/

2  Harker YS. In rural towns, immigrant doctors fill a critical need. Health Affairs. 2018;37(1):161-164.  u

3  https://www.aamc.org/system/files/2020-06/stratcomm-aamc-physician-workforce-projections-june-2020.pdf

4  https://blogs.bmj.com/bmj/2021/02/04/my-blackness-enters-the-room-first-an-immigrant-physicians-perspective-on-systemic-racism-in-the-us/

5  Benji K Mathews, MD, SFHM, Manpreet Malik, MD, FHM, Immigrant Physicians Fill a Critical Need in COVID

 

“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.”
hidden

Sexual Harassment in Medicine: reflections from the other side

Purvi Parwani, MBBS, MPH

The first week of March on Twitter was rather shocking for the entire medical community with news of a 45-million-dollar sexual harassment lawsuit against Oregon Health & Science University (OHSU) and a former anesthesia resident. Dr. Jason Campbell is accused in the suit of sending overtly sexual text messages and photos and sexually assaulting a social worker at the hospital. Women in Medicine (WIM) on different social media outlets (Twitter, Facebook, Instagram, and clubhouse) were outraged and shared their sexual harassment stories. For me, it was truly disheartening and took me back to my own experiences of sexual harassment since the early days in medical school. It bought back difficult memories as I was reminded of how over the years as this “stuff” happened, I had decided to hide it somewhere in my memory closet from where it couldn’t escape. This news and the other stories by WIM jolted my memory about all those painful experiences from back in the day to right in front of my eyes, whether I was ready to relive them or not. Like many other WIM expressed on social media I was numb to these happenings. I was sad for days. I feel vulnerable now writing about it since I never have shared any of these stories even with my family or parents. I just “dealt” with these incidences. It was part of my “normal” life as a woman, I had stopped recognizing how in my micro-conscious brain, this “small stuff” whether it was a remark about my body or an intentional touch by male colleagues or “unusual” and uncomfortable attention by men at work or by patients, bothered me over the years traumatizing me except I never wanted to give it any attention.

Our lives begin to end the day we become silent about things that matter!

–Martin Luther King Jr.

Years ago, in medical school during my final year in India, a tutor who would decide the patient subjects for the viva exam threatened to fail me in the exam if I didn’t “go” with him to his place on campus. I was frightened. I always ranked top in university and he blatantly had asked me if I didn’t follow what he said, I would lose my ranking. Thankfully, I was strong then as I am strong now and refused. I still remember those terrifying days leading up to the exams, I feared that he would follow me wherever I went, like an ominous dark shadow that was ever-present. I would sit in the library where I always remained visible to others rather than choosing my favorite quiet corners. I was given a completely normal patient during the exam but delivered a robust discussion about the normal anatomy and physiology of a women’s body. It was difficult to impress the examiner with a discussion focused on what is normal rather than around pathology, so my score was not as high as it may have been if I was given a more appropriate patient to discuss. Another time I had a patient who had an erection and asked me to touch him as I was examining his inguinal hernia. I was deeply affected by such incidences in medical school. This shaped my vision of coming to the United States for further training since I had heard that women in medicine in the US worked in better environments without such overt sexual harassment, but alas, I didn’t know how global the problem truly was. I would never forget getting stalked by the campus police officer as I was getting my passport to come to the US. I had to visit the police station to get the proof of identity and then found that police officer every day for a month outside my hostel, waiting to talk to me. Despite polite ways of telling him, I was not interested; he would show up the following day. How was I safe if the campus police officer was trying to stalk me? I still remember feeling terrified and thinking of being hurt every time I stepped outside the medical school hostel.

“When it’s “he said/she said,” the woman can’t win. But when it’s “he said/she said/she said/she said/she said/she said,” transparency has a chance, and light can flood the places where abusive behavior thrives.”

— Melinda Gates

More recently in the United States, I was asked by a leader in a medical organization (not my current institute) to meet over coffee. I genuinely thought it was for discussion of my career path as I received some “mentoring” from this individual. Midway during the meeting, he took something from my plate and said if it was allowed to eat from the plate of a date. My face went completely pale. How was this “meeting” and discussing my career a “date” that I never agreed to? I felt intensely uncomfortable and decided to leave after making an excuse. There are numerous other examples where I felt uncomfortable by colleagues, patients, or men at work that I just avoided- forget about confronting or reporting them. This “stuff” that made me uncomfortable back then and causes sympathetic overdrive even right now, while I am writing it, are examples of sexual harassment that makes me feel emotionally numb and forces me to hide it! Sexual harassment, stalking and discrimination is rampant during training for WIM even in 2021 in the United States. The power differential through the medical training makes it hard for our trainees to report it and as a result, the culture of chauvinism, and sexual harassment continues to grow.

“Sexual Harassment is not about attraction or desirability. It’s about exerting control over people whenever you can.”

— Anonymous

For anyone reading this post, I want to make one thing clear, any conversation or contact that makes the opposite person uncomfortable can be considered sexual harassment. Even in the cases where one may think they may have consented; the power differential NEVER gives the opposite person the freedom to consent. Sexual harassment is really not about sex. It’s about power and aggression and manipulation. It’s an abuse of power problem. We need to make sure that our trainees are empowered to report these incidences. We also need to make sure men start discussing these topics amongst themselves and identify the troubling language and behavior in fellow men and start calling them out. Men have to be interested in our safety for the culture to change. For either gender, we should acknowledge the bravery victims exhibit when they are sharing their story and thank them for confiding in us but more importantly give them the courage to report or do it for them. Medical organizations seriously need to understand that completing sexual harassment modules online does very little to prevent sexual harassment at the workplace. A stepwise approach that empowers the victim to report such incidences without fearing retaliation is a must.

I seriously cannot wait for a world of equity, equality, and accountability, where no one has the audacity to “accidentally” touch a woman without their permission, where women can thrive and are valued for their talent and brilliance and aren’t asked for sexual favors for a deserving opportunity, I cannot wait for a world where no one can utter the words “grab ‘em by their p****” and where the locker room talk isn’t about insulting womanhood.

This fight is difficult. I know there will be lots of disappointment and sadness like there was this month, which will be with us for a long time, but I am hopeful since these conversations are increasingly happening on social media openly and with candor!

“Self-respect by definition is a confidence and pride in knowing that your behavior is both honorable and dignified. When you harass or vilify someone, you not only disrespect them, but yourself also. Street harassment, sexual violence, sexual harassment, gender-based violence and racism, are all acts committed by a person who in fact has no self-respect.

Respect yourself by respecting others.”

— Miya Yamanouchi  

 

“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.”
hidden

Update on ACC/AHA Valvular Heart Disease Guidelines 2020: Deep Dive into Aortic Stenosis Treatment Options

Purvi Parwani, MBBS, MPH

“2020 ACC/AHA Guideline for the Management of Patients with Valvular Heart Disease” was co-published in the Circulation and in the Journal of the American College of Cardiology on December 17th, 2020. In this article, I will provide the recommendations and updates from these guidelines particularly the new changes compared to the older valvular disease guideline statement from 2014 and a focused update from 2017 as it pertains to aortic stenosis. In developing these recommendations, the writing committee used the available research through March 1st, 2020. Given the explosion of trials and studies in aortic stenosis (AS) management, the guidelines serve as a one-stop-shop for clinicians to dive deep for some guidance while taking care of patients with AS.

Aortic valve Recommendations:

The major change from the previous guidelines is that for symptomatic patients with severe AS who are >80 years of age or for younger patients with a life expectancy <10 years, TAVI (transcatheter aortic valve implantation) is recommended (Class 1) while for symptomatic patients with severe AS between age 65-80 with no anatomic contraindication to transfemoral TAVI, shared decision-making is emphasized, and the recommendation is either SAVR (surgical aortic valve replacement) or TAVI (Class 1).  Timing of aortic stenosis treatment is still largely decided by symptoms; however, asymptomatic patients with severe AS and low EF <50% are considered Class 1 for treatment. Similarly asymptomatic patients with severe AS and decreased exercise tolerance, or a fall in systolic blood pressure of ≥10 mmHg from baseline to peak exercise, or very severe AS (V2 ≥5 m/s), a BNP level  >3 times normal, or serial testing shows an increase in V2 ≥0.3 m/s per year are a Class 2 indication for valve replacement. The guidelines note the evidence from low-risk PARTNER 3 and Evolut trials.

Class 1 indication for SAVR
Class 1/A: Symptomatic severe AS
Class 1/B-NR: Symptomatic low flow low gradient severe AS with reduced LV EF (left ventricular ejection fraction)
Class 1/B-NR: Symptomatic low flow low gradient severe AS with normal EF when AS is the cause of the symptoms.
Class 1/B-NR: Asymptomatic severe AS and an LVEF <50%
Class1/B-NR: Asymptomatic going for other cardiac surgery
Class 1 for  SAVR or TAVI
Class 1/A: Symptomatic severe AS patients 65 to 80 with no contraindication to TAVI either SAVR or TAVI
Class 1 for TAVI (transcatheter aortic valve implantation)
Class 1/A: Symptomatic severe AS patients >80 or for younger patients with a life expectancy <10 years, TAVI recommended
Class 1/B-NR Asymptomatic patients with age >80 years with severe AS and an LVEF<50

 

The guidelines put much emphasis on “shared decision making with the patient” taking into account the patient’s values and preferences and include the discussion of the risk of anticoagulation therapy and the potential need for and risk associated with aortic valve interventions. Another point to note from the guidelines is that the differences in the treatment approaches are driven by the overall risk of the patient. Risk assessment involves but is not limited to the STS(Society of Thoracic Surgeons) score. Per the new guidelines, low risk is defined by an STS score of <3%. A risk assessment also includes the determination of frailty, cardiac and other system compromises, and procedure-specific impediments. These are nicely outlined in the guidelines, and in my opinion, every general cardiologist should dive deep into these risk assessment tools to determine the risk associated with aortic valve procedural treatment accurately for an individual patient. Table 9 in the guidelines includes examples of procedure-specific risk factors for interventions not incorporated into existing risk scores. As the options for the treatment of aortic valve heart disease has broadened, the value of the multidisciplinary heart valve team and heart valve centers has become apparent and this is clearly recognized in the guidelines. Primary and comprehensive heart valve centers are defined by the expertise and treatment options offered in the management of patients with valvular heart disease.

Another point to note is that asymptomatic severe AS category, SAVR versus TAVI options are only available for patients with severe AS and low EF <50%. For other factors that indirectly identify LV decompensation or faster progression of AS like decreased exercise tolerance or a fall in systolic blood pressure of ≥10 mmHg from baseline to peak exercise or a BNP level i>3 times normal or serial testing shows an increase in V2 ≥0.3 m/s per year, SAVR is recommended in preference to TAVI.  As the level of evidence builds up for role of TAVI in an asymptomatic category, it has the potential to be truly be a game changer treatment option for AS patients.

References:

Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP 3rd, Gentile F, Jneid H, Krieger EV, Mack M, McLeod C, O’Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A, Toly C. 2020 ACC/AHA guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines [published online ahead of print December 17, 2020]. Circulation. doi: 10.1161/CIR.0000000000000923

“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.”
hidden

Late-Breaking Science Presented at AHA20

Purvi Parwani, MBBS, MPH

For this blog dedicated to #AHA20,  I decided to put together a list of majority of American Heart Association (AHA) late-breaking study presentations at the 2020 Virtual AHA meeting from Day 1 to Day 3. So far, the late-breaking studies at AHA have covered a wide range of topics from heart failure, cardiovascular prevention focusing on a statin, newer LDL lowering therapies, Omge-3 fatty acid supplements, to polypills and imaging in women with MINOCA. Day 4 and Day 5 will cover multiple trials on atrial fibrillation, dual SGLT inhibitor, COVID, and Telemedicine.

Day 1

Name Trials Study Population Results Conclusion
GALACTIC HF

cardiac myosin activator Omecamtiv Mecarbil In Chronic Heart Failure with Reduced Ejection Fraction: The Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility In Heart Failure

 Inclusion Criteria

Patients 18-85 years of age with CHF and NYHA class II, III, or IV symptoms

LVEF ≤35% and pro-BNP ≥400 pg/ml

 

 N= 8256

Follow up= 21.8 months

Mean Age= 65 years

Primary Outcome=

cardiovascular death or CHF event

 

 

Mean LVEF: 27%

ACEi/ARNI  87%

Beta-blocker: 94%

Aldactone 78%

SGLT2iinhibitor: 2.5%

 Primary Outcome

37.0% of the omecamtiv mecarbil group compared with 39.1% of the placebo group (p = 0.03).

 

 Among patients with HFrEF on GDMT, the selective cardiac myosin activator omecamtiv mecarbil was superior to placebo. It was associated with a reduction in the primary composite outcome; however, no benefit in outcomes of CV Death, all cause death, or change in KCCQ total symptoms score.

 
AFFIRM-AHF

Ferric Carboxymaltose In Iron Deficient Patients Admitted for Acute Heart Failure

 

 Inclusion Criteria

Hospitalization for CHF, and iron deficiency anemia- Serum ferritin <100 ng/ml or serum ferritin 100-299 ng/ml and transferrin saturation <20%, LVEF <50%

 

 N= 1132

Follow up= 52 weeks

Mean Age= 71 yrs

Primary Outcome=

total heart failure hospitalizations and cardiovascular death

 

 Primary Outcome

52.5% of the ferric carboxymaltose group compared with 67.6% of the placebo group (p = 0.059).

 

 Among patients with CHF with iron deficiency, intravenous ferric carboxymaltose was associated with a numerical reduction in total heart failure hospitalizations and cardiovascular death.

 
VITAL

Omega-3 Fatty Acid and Vitamin D Supplementation In The Primary Prevention Of CV or cancer events

 Inclusion Criteria

Men >50 years or women >55 years without any known known cardiovascular disease or cancer

 N= 25,871

Follow up= 5.3 yrs

Mean Age= 67.1 yrs

Primary Outcome= CV death, nonfatal myocardial infarction (MI), or stroke

 

 Primary Outcome

The primary CV outcome of CV death, nonfatal myocardial infarction (MI), or stroke, for vitamin D3 vs. placebo, was 3.1% vs. 3.2%, hazard ratio (HR) 0.97, 95% confidence interval (CI) 0.85-1.1, p = 0.69.

 

 The results of this trial indicate that supplementation with either n–3 fatty acid at a dose of 1 g/day or vitamin D3 at a dose of 2000 IU/day was not effective in prevention of CV or cancer events

 
TIPS-3

A Polypill For Primary Prevention Of Cardiovascular Disease In Intermediate Risk People: Results Of The International Polycap Study

 

 Inclusion Criteria

Target CV disease (CVD) risk: >1.0%/year

Men ≥50 years and women ≥55 years with an INTERHEART Risk Score (IHRS) of ≥10, or men and women ≥65 years with an IHRS of ≥5

 

 N= 5713

Follow up= 4.6 yrs

Mean Age= 63.9 yrs

Primary Outcome= CV death, myocardial infarction (MI), stroke, heart failure (HF), cardiac arrest, revascularization

 Primary Outcome

Polypill vs placebo

4.4% vs. 5.5% (hazard ratio [HR] 0.79

 

 

 Once-daily polypill (fixed-dose combination of simvastatin, atenolol, ramipril, HCTZ) was superior to placebo in reducing systolic BP, LDL-C, and nonfatal CV events at approximately 5 years among intermediate CV risk patients, mostly in Southeast Asia

 

Day 2-3

 

Name Trials Topic of Interest Hypothesis Results
ALPHEUS

Ticagrelor Versus Clopidogrel In Elective Percutaneous Coronary Intervention

 

 Inclusion Criteria

Patients undergoing nonemergent PCI

At least one high-risk criteria: age >75 years, renal insufficiency, diabetes, body mass index >30 kg/m2, ACS in last year, LVEF <40% and/or prior episode of heart failure, multivessel disease, need for multiple stents, left main, bifurcation or complex PCI

 N= 1910

Follow up= 30 days

Mean Age= 66 yrs

Primary Outcome=

 Primary Outcome

MI ype 4a, 4b (stent thrombosis) or major myocardial injury at 48 hours

 

 Among patients undergoing elective and planned PCI, ticagrelor loading was not superior to clopidogrel loading. Ticagrelor failed to reduce the incidence of periprocedural myocardial infarction. Major bleeding was also similar between the groups, although an increase in nuisance or minor bleeding with ticagrelor.

 
HARP-MINOCA

Coronary OCT and Cardiac MRI to Determine Underlying Causes of Minoca in Women

 

 Inclusion Criteria

prospective, multicenter, international, observational study, women with a clinical diagnosis of MI were enrolled

 N= 170

145 with OCT;

116 with CMR

 

 46% pts with culprit lesion on OCT.

Abnormal CMR in 74% pts, ischemic pattern in 53%, nonischemic pattern in 20.7%,

 

 Multi-modality imaging with coronary OCT and CMR identified potential mechanisms in 84.5% of women with a diagnosis of MINOCA, three-quarters of which were ischemic and one-quarter of which were non-ischemic, alternate diagnoses to MI

 
RIVER 

Rivaroxaban Versus Warfarin In Patients With Bioprosthetic Mitral Valves And Atrial Fibrillation Or Flutter: Primary Results From The RIVER Randomized Trial

 

 

 Inclusion Criteria

≥18 years with bioprosthetic MV + AF/AFl without any contraindication to the AC

 

 N= 1005

Follow up= 1 yr

Mean Age= 59.3 yrs

Primary Outcome= death, major adverse cardiac events, major bleeding

Mean CHAD2vASC score= 2.6, HAS-Bled Score =1.6, 18% <3 months from MV surgery, 31% >5 yrs

 Primary Outcome

The mean time to the primary outcome for rivaroxaban vs. warfarin was 347.5 vs. 340.1 days (p < 0.0001 for noninferiority, p = 0.1 for superiority).

 

 

 rivaroxaban is noninferior to warfarin for prevention of thromboembolic events among patients with AF/AFL and a bioprosthetic mitral valve. All strokes were lower with rivaroxaban.

 
STRENGTH

Cardiovascular Outcomes with Omega-3 Carboxylic Acids (Epanova) In Patients With High Vascular Risk And Atherogenic Dyslipidemia

 

 Inclusion Criteria

Statin-treated patients ≥18 yrs with or at high risk for cardiovascular disease and TG 180-500 mg/dl, HDL <42 mg/dl (men) or 47 mg/dl (women)

 

 N= 13,078

Follow up= 42M

Mean Age= 63Yrs

Omega-3 CA Dose: 4 g/day

Primary Outcome=

cardiovascular death, MI, CVA, coronary revascularization, or hospitalization for unstable angina

 

 Primary Outcome met in

12.0% of the omega-3 CA group compared with 12.2% of the placebo group (p = 0.84).

 

 Among statin-treated patients with dyslipidemia and high cardiovascular risk, omega-3 CA was not superior compared to placebo.

 
OMEMI

Effects Of N-3 Fatty Acid Supplements on Clinical Outcome After Myocardial Infarction In The Elderly: Results Of The Omemi Trial

 

 

 

 

 

 

 

 Inclusion Criteria

Patients 70-82 years of age

With Myocardial infarction 2-8 weeks prior to randomization

 

 N=1,027

Follow up= 24M

Mean Age= 74Yrs

PUFA dose: 930g EPA+ 660g DHA

Primary Outcome=

all-cause death, nonfatal MI, revascularization, CVA, or hospitalization for heart failure

 

 Primary Outcome

21.0% of the PUFA group compared with 19.8% of the placebo group (p = 0.62).

 

 Among elderly patients with recent myocardial infarction, PUFA was not beneficial.

 
SAMSON

A Three-arm N-of-1 Trial with Statin, Placebo And Tablet Free Periods, To Verify Side Effects And Identify Their Cause

 Inclusion Criteria

Patients with any adverse event within 2 weeks of starting a previous statin

 N= 60

Follow up= 12 months

Primary Outcome:

placebo symptoms divided by statin symptoms= termed nocebo ratio

 

 Nocebo ratio was 0.90- meaning 90% of symptoms elicited by placebo tablets Patients with previous adverse event to statin, 90% of the symptoms could be attributed to the nocebo effect
 

EVINACUMAB

The Efficacy and Safety Of angiopoietin-like 3 (ANGPTL3) inhibitor

-Evinacumab In Patients With Refractory Hypercholesterolemia

 

 Inclusion Criteria

Diagnosis of primary hypercholesterolemia (either heterozygous familial hypercholesterolemia [HeFH] or non-HeFH) with clinical atherosclerotic cardiovascular disease (ASCVD) with statin (± ezetimibe) at the maximum tolerated dose, PCSK9 inhibitor for at least 8 weeks with LDL-C ≥70 mg/dl or 100 mg/dl with or without clinical ASCVD, respectively

 

 N= 160 (SC), 106 (IV)

Follow up= 16 weeks

Mean Age= 54 years

Primary Outcome=

 Primary Outcome

percent change in LDL-C from baseline

 

Phase II trial

small and underpowered for clinical outcomes

 

 Evinacumab is superior to placebo in reducing LDL-C among patients with refractory hypercholesterolemia despite being on statins, ezetimibe, and PCSK9 inhibitors (baseline LDL-C: ~150 mg/dl)

 
SHORT-DAPT

One Month Dual Antiplatelet Therapy Followed By Aspirin Monotherapy After Drug Eluting Stent Implantation

 Inclusion Criteria

Patients ≥19 years of age

undergoing PCI for stable or unstable ischemic heart disease

AMI excluded

 

 N= 3020

Follow up= 12 months

Mean Age= 67 yrs

Primary Outcome=

cardiac death, nonfatal myocardial infarction, target-vessel revascularization, stroke, or major bleeding at 12 months

 

 Primary Outcome

5.9% of the 1-month DAPT group compared with 6.5% of the 6- to 12-month DAPT group (p for noninferiority < 0.001; p for superiority = 0.48).

 

 Among patients undergoing PCI for stable or unstable coronary artery disease, 1 month of DAPT was noninferior to 6-12 months of DAPT

 

 

“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.”
hidden

Deep Dive in HARP Trial

Purvi Parwani, MBBS, MPH

“Coronary Optical Coherence Tomography (OCT) and Cardiac Magnetic Resonance (CMR) Imaging to Determine Underlying Causes of MINOCA in Women” was presented on day 2 of AHA by Dr. Harmony R. Reynolds, MD during the late-breaking trial session. The trial is also simultaneously published in Circulation(1).

MINOCA (Myocardial Infarction with Nonobstructive Coronary Arteries) is quite a contemporary diagnosis. The term was initially coined by Dr. Beltram in an editorial, in response to a Swedish paper that described the cardiac magnetic resonance imaging findings in patients that had presented with myocardial infarction however did not have any significant coronary artery disease on cardiac catheterization(2).  MINOCA affects 6-15% of the patients presenting with MI and disproportionately affects women(1). In 2017, The European Society of Cardiology developed the first international position article on MINOCA and proposed the following MINOCA criteria: (a) AMI criteria as defined by the “Third Universal Definition of Myocardial Infarction”; (b) nonobstructive coronary arteries as per angiographic guidelines, with no lesions ≥50% in a major epicardial vessel; and (c) no other clinically overt specific cause that can serve an alternative cause for the acute presentation (3). Fundamental to the definition of MINOCA is the diagnosis of AMI with an elevated cardiac biomarker, typically a cardiac troponin >99th percentile with a rise or fall in the level on serial assessment. Although elevated troponin levels are indicative of myocyte injury with the release of this intracellular protein into the systemic circulation, the process is not disease-specific and can result from either ischemic or nonischemic mechanisms. MINOCA thus, becomes a working diagnosis. The role of CMR is crucial to establish the etiology in these patients. In 2019, an AHA statement paper on MINOCA, presented a stepwise diagnostic approach to evaluate the etiology(4). This paper proposed the use of coronary imaging after the CMR diagnosis of MI was established to further evaluate coronary etiology in absence of significant atherosclerotic disease. Earlier this year, ESC NSTEMI guidelines suggested class IB indication to perform CMR in patients with MINOCA, recommended use of traffic light diagnostic algorithm, and mentioned the use of OCT for the detection of unrecognized causes at coronary angiography, especially in suspected cases of thrombus, plaque rupture or erosion or SCAD(5).

 

The goal of the Women’s Heart Attack Research Program (HARP) was to implement an imaging protocol to evaluate the underlying causes of MINOCA, in order to guide clinical practice.

They enrolled 301 women presenting with a diagnosis of MI before the coronary angiography was done, in a prospective manner.  170 patients were diagnosed with MINOCA, out of which 145 had OCT imaging while 116 underwent CMR. The study established the cause of MINOCA in 84.5% of the women who underwent multi-modality imaging (98/116), compared with either OCT or CMR alone. OCT was able to identify culprit lesion in 46% of the patient while 74% of the patients had abnormal CMR. 53% of the patients had late gadolinium enhancement or edema in the coronary territory and ischemic pattern while almost 21% of patients were found to have myocarditis, stress-induced cardiomyopathy, or other nonischemic cardiomyopathies. Almost 15.5% of patients had no identifiable mechanism by OCT or CMR. Half of the patients with ischemic patterns on CMR didn’t have any culprit lesion on OCT. Alternative mechanisms of MI like coronary spasm or thromboembolism leading to MI are suggested in those patients. The study however didn’t perform any provocative testing to induce spasm. Similarly, 40% of the patients with normal CMR had culprit lesion on the OCT. This is lower compared to the latest CMR MINOCA studies where a diagnosis was established up to 87% of the cases(6). Whether these findings are due to shorter duration of ischemic injury or due to longer time between diagnosis of MI and CMR or maybe due to overestimation of the prevalence of abnormalities on OCT given the blinded core laboratory review, remains the point of discussion.

The authors conclude that the Multi-modality imaging with coronary OCT and CMR identified potential mechanisms in 84.5% of women with a diagnosis of MINOCA in this observational study.  The study was not designed to test the outcomes and further research is needed to establish if the OCT improves outcomes in patients with a working diagnosis of MINOCA. I am not certain if the trial will impact any OCT recommendation class in future guidelines given the absence of the outcome data and observational nature of the trial. The trial also suggested simultaneous use of OCT and CMR in cases of MINOCA however perhaps establishing the diagnosis MI with CMR, excluding myocarditis and nonischemic cardiomyopathy, in cases with a working diagnosis of MINOCA remains the key. As suggested by the diagnostic algorithm in the guidelines, once the MI diagnosis is established, OCT may be used to evaluate coronary mechanisms, however till the outcome data with OCT is available, this will probably depend on the preference of the clinical cardiologist and local availability. Given more than half of the patients with ischemic pattern on CMR had no culprit lesion on OCT in this trial, we may need more data before recommending regular simultaneous use of OCT and CMR.

 

References:

  1. Coronary Optical Coherence Tomography and Cardiac Magnetic Resonance Imaging to Determine Underlying Causes of MINOCA in Women | Circulation [Internet]. [cited 2020 Nov 15]. Available from: https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.120.052008
  2. Beltrame JF. Assessing patients with myocardial infarction and nonobstructed coronary arteries (MINOCA). Journal of Internal Medicine. 2013;273(2):182–5.
  3. Agewall S, Beltrame JF, Reynolds HR, Niessner A, Rosano G, Caforio ALP, et al. ESC working group position paper on myocardial infarction with non-obstructive coronary arteries. Eur Heart J. 2017 Jan 14;38(3):143–53.
  4. Contemporary Diagnosis and Management of Patients With Myocardial Infarction in the Absence of Obstructive Coronary Artery Disease: A Scientific Statement From the American Heart Association | Circulation [Internet]. [cited 2020 Nov 15]. Available from: https://www.ahajournals.org/doi/full/10.1161/CIR.0000000000000670
  5. 2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation | European Heart Journal | Oxford Academic [Internet]. [cited 2020 Nov 15]. Available from: https://academic.oup.com/eurheartj/advance-article/doi/10.1093/eurheartj/ehaa575/5898842
  6. Troponin-positive chest pain with unobstructed coronary arteries: incremental diagnostic value of cardiovascular magnetic resonance imaging | European Heart Journal – Cardiovascular Imaging | Oxford Academic [Internet]. [cited 2020 Nov 15]. Available from: https://academic.oup.com/ehjcimaging/article/17/10/1146/2197117

“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.”