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Baltimore, MD
Doctors Paid for Use of a Manufacturer’s Brand of Implantable Cardioverter-Defibrillator (ICD)
Another study of how Medical device manufacturers manage to pay doctors to prescribe their product, in this case, brands of ICDs. A JAMA study documented that “physicians were most likely to use the ICD brand from the manufacturer who gave them the most money.”
(But it should be noted that there was no association between the amount physicians received and postprocedural complications and/or death.)
Study of Payments to Doctors
In this study patients received a first-time implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) from any of the 4 major manufacturers.
A normal chest X-ray after placement of an ICD
Data came from the National Cardiovascular Data ICD Registry linked with the Open Payments Program’s payment data.
Over a 3-year period (2016-2018), 145,900 patients received these devices. They were implanted by 4,435 physicians at 1,763 facilities. 94% of these physicians received payments from these device manufacturers.
Between 38.5% and 54.7% of patients received devices from the manufacturers who had provided the physicians with the largest payments.
For example, doctors who received the highest payments from “manufacturer A” were about 6-fold more likely to use its product versus an ICD from a company that didn’t pay them. This is according to Jeptha P. Curtis, MD, and colleagues at Yale School of Medicine in New haven, CT.
“Manufacturer D” did even better at rewarding doctors who used its ICDs. Those receiving the highest payments were 17-fold more likely to use its devices.
Is “Buying Off” Physicians Unethical and/or Illegal?
To this question Dr. Curtis replied:
“Instead I think it represents a softer type of influence. If I have a choice of devices from different manufacturers, and I have financial entanglements with one of them, it stands to reason that I will be more likely, consciously or not, to select that manufacturer, particularly if I do not think there is a difference in device performance.”
Current laws, such as the Anti-Kickback Statute and The Stark Law can be circumvented by saying the payments are for such things as speakers’ fees or travel costs. The Curtis study didn’t examine differences in types of payments such as consulting fees versus food and beverage payments (a definite limitation).
Editor’s Comments
Payments to doctors by device manufacturers (and pharmaceutical companies), however they are justified, undermine the reputation and trust we ought to have in our doctors.
As consumers, we must do all we can to make sure that laws are written or revised to address these payments.
To quote Dr. Curtis, “Patients need to know that decisions regarding their care have been made on the basis of fact and science, not on how much money their physician received from a device company.”
Hospitalized COVID-19 Patients and Cardiac Scar Tissue
Much has been learned about COVID-19 in the last year. Of special interest to A-Fib patients are the possible effects on the heart.
Some studies of hospitalized COVID-19 patients report it’s common to find scars on the muscular tissue of the heart (myocardial lesions). Even those with a milder case of the virus are experiencing adverse effects on their heart health.
Currently, we don’t know if those cardiac scars could lead to future rhythm disorders. In the short-term, there seems to be no consequences.
A-Fib causes fibrosis that remodels your heart
What’s All the Fuss about Cardiac Scar Tissue (Fibrosis)?
Scar tissue is basically dead tissue with reduced or no blood flow. Over time it makes the heart stiff, less flexible and weak. This fibrotic tissue overworks the heart and reduces pumping efficiency.
Danger of Fibrosis: Any type of scarring and fibrosis in the heart may eventually affect heart function that could lead to heart failure and sudden cardiac death.
COVID-19 and A-Fib? We know that being in A-Fib can lead to scarred tissue (fibrosis) especially over time. Could COVID-19 produce the same type of scarring and contribute to your A-Fib?
You can reduce this risk by getting the COVID-19 vaccine to protect your heart.
VIDEO: Feb 2021: “How COVID-19 Affects the Heart“
Interview with Dr. Teresa Daniele, chief of cardiology at UCSF Fresno who shares with us how COVID-19 can affect people’s cardiac systems; and how the virus can cause direct inflammation of the heart, weakness and formation of muscle scar tissue. Published by MedWatch Today. Feb 22, 2021. (3:13 min.)
YouTube video playback controls: When watching this video, you have several playback options. The following controls are located in the lower right portion of the frame: Turn on closed captions, Settings (speed/quality), Watch on YouTube website, and Enlarge video to full frame. Click on arrow icon to start playback.
Air Quality, Pollution and Atrial Fibrillation: Is There a Link?
Millions of people live in areas where air pollution can cause serious health problems. Local air quality can affect our daily lives. Like the weather, it can change from day to day.
Researchers wanted to know if there’s a role of traffic & non-traffic air emissions in triggering cardiovascular (CV) hospitalizations.
They tested levels of air pollution (i.e. particulate matter, PM) in multiple urban areas of New York State, then the next day correlated this data with hospitalizations for arrhythmia.
Research Findings: This research revealed that higher pollution levels lead to:
• more than doubled hospitalization for A-Fib;
• nearly quadrupled hospitalizations for stroke.
This is a wake-up call for anyone with Atrial Fibrillation who lives in an urban setting.
Air quality is a measure of the solid particles and liquid droplets found in outdoor air. These pollutants (particulate matter) are emitted from power plants, industries and automobiles.
How Can I Reduce My Exposure to Air Pollution? You can use air quality alerts to protect yourself and others when particulate matter (PM) reaches harmful levels.
The Air Quality Index (AQI) tells you how clean or polluted your outdoor air is, along with associated health effects that may be of concern. Learn how you can get AQI notifications sent to you.
Check the Air Quality Data Where You Live: There’s a nifty little app to check your area’s air quality rating for today. Just enter your city name (it displays the best matches to select from) or enter your zip code.
The AQI “dial” will appear with your location’s information. See graphic example (right). To check your area’s air quality, go to AirNow (https://www.airnow.gov/)
Bottom Line if You Have A-Fib: Be aware of the air quality where you live. Protect yourself. Stay informed. (Many news channels report the AQI each day.)
If you have an inkling that your air quality might be low that day, go online and check the Air Quality Index for your locale. If it’s low, stay indoors. Curtail or postpone outdoor activities. If you must go out, use your car’s air conditioner.
COVID-19: White House Pushes Unproven Drugs—Risk of Arrhythmias and Sudden Death
by Steve S. Ryan
Note: I have already written about the risk of COVID-19 for patients with A-Fib (and other cardiovascular diseases). See my post: COVID-19 Virus: Higher Risk for A-Fib Patients.
In recent coronavirus pandemic press conferences, President Donald Trump has repeatedly advocated the use of the drugs hydroxychloroquine (HCQ) and azithromycin (Z-Pak) to treat the COVID-19 virus.
He often says, “What have you got to lose?” About treating patients, he also said these drugs can “help them, but it’s not going to hurt them.” (Really?)
Hydroxychloroquine & Azithromycin Danger―“What Have You Got to Lose?”
The drugs hydroxychloroquine and azithromycin are currently gaining attention as potential treatments for COVID-19. Hydroxychloroquine sulphate (Plaquenil) is an antimalarial medication. Azithromycin (Z-Pak) is an antibiotic. (Antibiotics in general are ineffective against viruses.)
Each has potential serious implications for people with existing cardiovascular disease.
Contrary to Mr. Trump’s statements, you do have a lot to lose. Medical groups warn that it’s dangerous to be hawking unproven remedies.
Recently, three U.S. heart societies published a joint statement to detail critical cardiovascular considerations in the use of hydroxychloroquine and azithromycin for the treatment of COVID-19.
According to the “Guidance from the American Heart Association, the American College of Cardiology and the Heart Rhythm Society”:
Complications include severe electrical irregularities in the heart such as arrythmia (irregular heartbeat), polymorphic ventricular tachycardia (including Torsade de Pointes) and long QT syndrome, and increased risk of sudden death.
The effect on QT or arrhythmia of these two medications combined has not been studied.
With these increased dangers in mind, we must not take unnecessary (or foolish) risks in the rush to find a treatment or cure for COVID-19.
What We Know So Far About These Drugs and COVID-19
COVID-19 Virus: Higher Risk for A-Fib Patients
COVID-19, the disease caused by the new coronavirus SARS-CoV-2, has sickened hundreds of thousands and continues to kill large numbers of people worldwide.
Typically, it’s considered a threat to the lungs, but COVID-19 also presents a significant threat to heart health, according to recently published research.
“But It’s Just the Flu, Right?”
“During most flu epidemics, more people die of heart problems than respiratory issues like pneumonia,” according to Dr. Mohammad Madjid, McGovern Medical School at UTHealth. He expects similar cardiac problems among severe COVID-19 cases.
In addition, COVID-19 can worsen existing cardiovascular disease. For example, Atrial Fibrillation patients may develop myocarditis, an inflammation of the heart muscle. If left untreated, myocarditis may lead to symptoms of heart failure.
And for otherwise healthy people, COVID-19 can cause new heart problems.
Comorbid Conditions Increase Fatality Rate
Many A-Fib patients also suffer from other chronic conditions such as diabetes and hypertension. With comorbid conditions, COVID-19 can increase the severity and fatality of the virus.
According to research from the Chinese Center for Disease Control and Prevention (CCDC), COVID-19 patients from mainland China who reported no comorbid conditions had a case fatality rate of 0.9%.
While patients with the following comorbid conditions had much higher rates:
+ 10.5% for those with cardiovascular disease
+ 7.3% for diabetes
+ 6.3% for chronic respiratory disease
+ 6.0% for hypertension
+ 5.6% for cancer.
Among critical cases, the case fatality rate is unsurprisingly highest at 49%.
Take Away: A-Fib Patients at Higher Risk for COVID-19
Patients with underlying cardiovascular disease (i.e., A-Fib) are at higher risk for developing COVID-19 and have a worse outlook. Prior heart disease is a risk factor for higher mortality from COVID-19. Cardiovascular patients are encouraged to take additional, reasonable precautions to avoid contact with the COVID-19 virus. And to stay current with vaccinations, especially for influenza and pneumonia. Since people can spread the COVID-19 virus before they know they are sick, it is important to stay away from others when possible, even if you or they have no symptoms. • Stay at least 6 feet (2 meters) from other people Social distancing is especially important for people who are at higher risk of getting very sick including older adults and people of any age who have serious underlying medical conditions. For more information: see the article “How to Protect Yourself & Others” from the Centers for Disease Control and Prevention (CDC).A-Fib Patients: Practice Social Distancing and Stay Safe at Home
• Do not gather in groups
• Stay out of crowded places and avoid mass gatherings
Help Michele: Share your A-Fib Experince With Wearable Heartrate Monitoring Devices
One of our A-Fib Support Volunteers, Michele Straube, will be participating as a patient advocate on a panel during the annual Heart Rhythm Society conference in San Francisco, CA, May 2019. The panel presentation is entitled “The Wearable and Apps: Show Me the Data”. The other panel members, and the workshop audience are medical professionals and experts in cardiac rhythm management
To help Michele share a broad patient perspective, she would greatly appreciate you answering a short survey with your thoughts on wearable/portable devices/apps that provide AFib-related information. Your input may influence what new devices or apps are developed.
All answers will be held confidential. Survey results will be compiled in an anonymous way to share with the Heart Rhythm Society 2019 audience. No individual information will be shared.
Michele S.
The 12-question survey should take no longer than 10 minutes to complete. The survey is open until April 15, 2019. To participate, go to survey: https://www.surveymonkey.com/
You can read Michele’s A-Fib story at Cured After 30 Years in A-Fib by Dr. Marrouche.
Personal Update on the Malibu Fires
An update to our earlier post about evacuating our home because of the Malibu brush fires. Rest assured we are okay. Got back into our home this past Tuesday. Still no power, but water (and toilet) is working. Local hotel hosted all evacuees for Thanksgiving dinner. God bless all our fires fighters, first responders and volunteers.
Our home is okay, just a few singed palm trees and spots of burnt brush. Thanks to God.
A few photos for you. Continue to pray and send us your positive thoughts. Will write more soon.
A-Fib Self-Care Skills: How to Check Your Heartbeat and Heart Rate
Some Atrial Fibrillation patients know immediately when their heart is in A-Fib. They experience one or more symptoms including shortness of breath, palpitations, heart flutters, etc. Other A-Fib patients may have subtle symptoms (or silent A-Fib) and can’t be sure.
The following self-care skills will reassure you any time you suspect you’re in A-Fib—how to check for an irregular heartbeat and how to tell if your heart rate is too fast or too slow.
Self-Check if Your Heartbeat is Regular or Irregular
I found an informative post with these self-care skill steps on the Scope Blog by Stanford University School of Medicine. To check whether your heartbeat is regular or irregular:
♥ Begin by placing your right hand on the left side of your chest while seated and leaning forward.
♥ Position your hand so that you feel your heartbeat most strongly with your fingertips.
♥ A normal heart rhythm should feel like a regular drum beat cadence; you can usually anticipate when each beat will come after the last beat.
♥ Because heart rate and the strength of the heartbeat can vary with breathing, sometimes holding your breath for a few seconds is helpful. With an irregular rhythm, it will be hard to predict when the next beat will come.
♥ In addition, some irregular beats will be softer (less strong) than other beats, so the strength as well as the timing may not be consistent.
Self-Check If Your Heart Rate is Too Fast or Too Slow
The Stanford blog continues with a second set of self-care skill steps—how to measure if your heart rate is too fast or too slow so you know when to seek medical care. (An optimal heart rate is 50–100 bpm when you are at rest.) To check your heart rate:
♥ Place your right hand over your heart so that you feel your heart beating under your fingertips.
♥ Use a watch or timer and count the number of beats for 15 seconds.
♥ Be sure to count all heartbeats; including beats that are not as strong or that come quickly following one another.
♥ Take the number of beats you’ve counted and multiply it by four. For example, if you count 30 beats in 15 seconds, then you would calculate 4 x 30 = 120 beats per minute.
♥ Repeat this process three times right away, writing down each heart rate to later share with your doctor.
While an Electrocardiograph (ECG or EKG) or Holter monitor are the only sure ways to document you are in A-Fib, you can use the above self-care skills to recognize A-Fib symptoms of an irregular heart beat or if beating too fast or too slow.
These skills with help you remain calm and confident when you suspect you may be in A-Fib.
Part II Framingham Study: Research Milestones in Heart Disease and Atrial Fibrillation
Now celebrating its 70th year, the Framingham Heart Study (FHS) is a long-term, ongoing cardiovascular study of residents of the city of Framingham, MA, a small, middle-class community 23 miles west of Boston.
Starting in 1948, the objective of the Framingham Heart Study was to identify the common factors that contribute to cardiovascular disease by following its development over a long period of time. Participants would have no overt symptoms of heart disease and not suffered a heart attack or stroke. Today 15,447 people of varying ages, backgrounds and heritage are enrolled including second and third generations.
Findings Integral to Scientific Understanding A-Fib
The Framingham study has contributed greatly to our understanding of Atrial Fibrillation and to the risk of stroke, heart attack and heart failure. A few important milestones about A-Fib include:
1957 High blood pressure and high cholesterol levels increase likelihood of heart disease
1960 Cigarette smoking found to increase the risk of heart disease
1970 Atrial fibrillation increases stroke risk 5-fold
1982 Chronic atrial fibrillation associated with a doubling of overall mortality and of mortality from cardiovascular disease
1991 Atrial fibrillation as an independent risk factor for stroke
1994 Diabetes and hypertension risk factors for atrial fibrillation
2002 Obesity is a risk factor for heart failure
2009 New genetic variant associated with increased risk for atrial fibrillation
2010 Sleep apnea tied to increased risk of stroke
2010 Having first-degree relative with atrial fibrillation associated with increased risk
Framingham Research: Expect More Findings About Atrial Fibrillation
Framingham scientists circa 1948
Framingham data resources are available for researchers to use, and those data continue to spur new scientific discoveries. The study data has spawned over 3,600 published studies in medical, peer-reviewed journals.
As A-Fib patients, we owe a huge debt to the Framingham participants, doctors, scientists and researchers. With continuation of the Framingham Heart Study, we can expect more research findings about Atrial Fibrillation for years to come.
Celebrating 70 Years of the Framingham Heart Study: Solving Mysteries of Heart Disease
When I first started researching my A-Fib back in 1998, I kept coming across research studies that credited its data to the Framingham Heart Study. I had no idea how influential the study has been to expanding our understanding of cardiovascular health.
The Framingham Heart Study (FHS) is a long-term, ongoing cardiovascular study of residents of the city of Framingham, MA, now celebrating its 70th year. The study was commissioned by the U.S. Congress and had been intended to last for only 20 years.
The Lifesaving Power of Scientific Research
Much of the now-common knowledge concerning heart disease, such as the effects of diet, exercise, smoking, good and bad cholesterol and high blood pressure is based on this longitudinal study. As well as far-reaching programs in stroke and Alzheimer’s.
Before the FHS, doctors had little sense of prevention.
–Nancy Brown, CEO, AHA
American Heart Association CEO Nancy Brown said new approaches and therapies have sprung from Framingham’s work. “Framingham is living proof of the lifesaving power of scientific research. It’s no coincidence that deaths from heart disease have declined over the 70 years of this groundbreaking study.”
The study has huge repositories of data, from cell lines and gene sequences to scanned images of the heart, brain, bone and liver.
“Every part of the body that can be measured, imaged or assessed, we’ve done so over the last 70 years,” said Dr. Vasan S. Ramachandran, principal investigator and director of the study for Boston University. “It’s a remarkable human experiment. It’s with humility I say that. It’s unbelievable, and to be part of it is a gift, a privilege and an honor.”
Framingham: The Study and the Town that Changed the Health of a Generation
Framingham doctors in 1948
The study began in 1948 with 5,209 adult subjects (mostly white women and men) from Framingham, (about two-thirds of the town) and now has over 14,000 people from three generations.
Participants, and their children and grandchildren, voluntarily consented to undergo a detailed medical history, physical examination, and medical tests every two years, creating a wealth of data about physical and mental health, especially about cardiovascular disease.
Judie Saltonstall is one of them. She’s a second-generation participant who moved to Arizona 29 years ago and still faithfully logs on to her computer every three months to answer questionnaires and memory quizzes.
The 75-year-old is part of a contingent of FHS participants living all over the country who travel back to Framingham whenever needed for exams and tests. She reels off a list: retina photographs, bone density tests, and MRIs of the brain, heart and abdomen.
“It’s kind of exciting to do,” said Saltonstall, a mother of four and a former teacher. “It’s important for me personally, but also for them to know what’s going on with me and to learn from that, whatever good it does.”
Adding Different Segments (“Cohorts”)
In 1968, despite the recommendation to end the study as scheduled, Congress voted to continue it. Over the decades, the study had been split into different segments, or “cohorts”:
• The Original Cohort (1948)
• Offspring Cohort, the second generation (1971)
• The Omni Cohort asked people of color to volunteer to study race and heritage in heart factors (1994)
• The Generation Three Cohort (2002)
• The Omni Two Cohort, the second generation of Omni Cohort participants (as young as 13 years of age, 2003).
Landmark Study: Inspiring Thousands of Published Studies
Framingham, MA, circa 1948
It’s been 70 years since a small, middle-class community 23 miles west of Boston became the linchpin in helping to solve the mysteries of heart disease.
Framingham data resources are available for researchers to use, and those data continue to spur new scientific discoveries. FHS data has spawned over 3,600 published studies in medical, peer-reviewed journals. (Including many studies about Atrial Fibrillation, heart arrhythmias, and prevention of strokes).
The Framingham Heart Study is a joint project of the U.S. National Heart, Lung, and Blood Institute (NHLBI) and Boston University. Learn more at News on Framingham Heart Study.
As A-Fib patients, we owe a huge debt to the Framingham participants, doctors, scientists and researchers.
VIDEO: Framingham Heart Study: The First 70 Years
Learn about the legacy of the Framingham Heart Study. Includes interviews with participants; current and historical photos and footage. 12:17 min. Go to video.
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