Devices Designed to Keep Your Heart Beating

Cardiovascular disease, commonly known as heart disease, can lead to serious health issues. The fact of the matter is that heart disease is the leading cause of death in the U.S. for both men and women, according to data from the Centers for Disease Control and Prevention. Death rates could be much higher were it not for devices such as defibrillators and pacemakers, which save millions of people around the world each year.

Medical devices in this country are regulated by the U.S. Food and Drug Administration (FDA). Safety and effectiveness are tested before a product hits the market. Devices in the heart disease category are used to treat cardiovascular diseases, conditions, and other heart related issues. Some of the devices that are approved by the FDA are implanted in the human body, while others are used on the outside.

A List of Some of the Available Heart-Related Devices

All manners of cardiovascular issues are treated by FDA approved devices, including those listed below:

  • Automated external defibrillators (AEDs): These come in portable and automatic formats, and are used to restore a normal heart rhythm when a patient goes into cardiac arrest. These devices analyze the heart rhythm so that medical professionals can decide whether or not a shock needs to be administered to restore normal function.
  • Cardiac ablation catheters: These are long, thin tubes that are threaded into or onto the heart. Cardiac ablation catheters are used on patients with heartbeats that are abnormally fast, and they work by making modifications to small areas of heart tissue where the abnormalities are originating.
  • Cardiovascular angioplasty devices: These tubes are thin, long, and flexible, and are threaded into the heart or blood vessels in areas that have experienced a blockage. Blood flow is improved, and chest pains are reduced using these devices.
  • Cardiac pacemakers: Battery-operated pacemakers are implanted into the body to help regulate a heart that sometimes beats too slowly. They work by checking electrical impulses of the heart and delivering electrical stimulation when the heartbeat gets out of its natural rhythm.
  • Implantable cardioverter defibrillators (ICDs): These devices are used to monitor heart rhythms and deliver an electric shock if those rhythms become too fast. Some devices will even record patterns so that they can be reviewed by health professionals. Newer models will even send basic information to the doctor of the user.
  • Prosthetic (artificial) heart valves: Heart valves direct blood flow through the heart, and need to be replaced when they become dysfunctional. There are two replacement options: mechanical valves are comprised of man-made materials, while bioprosthetic valves are created using tissue from human cadavers or animals.
  • Stents: These lattice-shaped tubes are permanently inserted into arteries to help improve blood flow. Some stents will contain drugs that are there to ensure that further blockages do not occur.
  • Ventricular assist devices (VADs): These devices are used to help weaker bloods become more effective at pumping blood. VAD’s were initially used as a short-term treatment for heart transplant recipients, but are now often used on patients with heart issues who are not considered a good candidate for a heart transplant.


Tips to Prevent Heart Disease

The Centers for Disease Control and Prevention (CDC) estimates that heart disease is the leading cause of death for women in the United States, which means one in four women will die from heart disease in America.

There are some preventive strategies you can adopt to reduce the risk of heart disease. The FDA has recommended the following tips to assist women in reducing the risk of death from heart disease.

Tips to Reduce Your Risk

Although heart disease can cause stroke and heart attack fatalities, there are some strategies you can employ to decrease the risk.

Take care of your current health issues. Conditions like high blood pressure, high cholesterol, and diabetes all increase the potential for heart disease if you don’t discuss with your health care provider the best treatment options for these conditions.

Quit smoking. The FDA’s website has great information on medical treatments to help you stop the habit.

Exercise regularly for healthy weight maintenance. Everybody may not be a gym fan and can complete all their exercises in one set. You may have to start out by walking or doing some other activity as your doctor recommends.

Know the symptoms of a heart attack in women.  Call 911 if you feel you are having the symptoms of a heart attack: nausea, ache or tight feeling in the chest (or jaw, neck or abdomen), or shortness of breath.

A daily aspirin regimen is not for everybody. Before committing to an aspirin regimen as a heart attack preventative, consult your doctor first.

Eat healthier.  A diet rich in fruits and vegetables and limited in fats and sugars is good prescription for healthier eating. Also, include more whole grains and less prepared and packaged/processed foods. Check out the food labels to see what you are consuming in the food products you buy. You may want to discuss your dietary needs with your health care provider.

Always consult your health care provider before committing to a clinical trial for heart medications or treatments.  A clinical trial is an experimental study requiring human volunteers to test out new medicines and treatments.

Menopause and Heart Health

The decrease in estrogen that occurs during menopause can be a contributing factor for the increased risk of heart disease in women. Weight gain is another menopause factor that may also contribute. To remedy the issue of decreased estrogen, hormone therapy is often done to remedy some of the ailments of menopause.

Salt in Your Diet

Are you conscious about the amount of salt (aka sodium chloride) you eat? Are you certain the amount of salt you eat is appropriate for your body?

You may be surprised to find out you consume more salt than you think.

You may not use salt at all, and you still may be consuming too much of it if you eat a lot of prepared and processed foods. As a matter of fact, the sodium in most people’s diets in the United States comes from processed and prepared foods found in restaurants and grocery stores.

Now, the U. S. Food and Drug Administration (FDA) is trying to restrict the amount of sodium added to foods. A draft guidance for industry has been released by the FDA with the intent to have industries decrease the amount of sodium added to prepared and processed foods. The restriction concerns the amount of salt added to your foods before by the restaurants and manufacturers before you even get a chance to season them yourself.

The objective of the FDA is to have people decrease their daily salt intake to 2,300 milligrams (mg) a day, which is the equivalent to a teaspoon of salt. Right now, Americans consume about 50% more than what’s recommended for a daily allowance.

The Problem with Excess Sodium Consumption

The terms salt and sodium may be used as synonyms, but they are not identical substances. Salt is the crystal-like substance you sprinkle over your food and is 40% sodium and 60% chloride. Sodium is a mineral found in salt, but salt is the primary form that you consume sodium. Almost 95% of the sodium consumed–whether added by you or added by the manufacturer comes in salt form.

The body needs sodium to assist in doing its daily functions, and sodium can be found naturally in a lot of foods (including milk, beets and celery). Regardless of which form it’s in, sodium is also used to improve flavor, thicken foods and preserve foods.

The downside of sodium is the potential for it to cause high blood pressure, which is a precursor to heart disease and stroke. Therefore, a lot of deaths and sickness can be eliminated just by decreasing sodium intake.  

What Foods Are Typically High in Sodium?

Prepared and processed foods like soups, cheese, pizza, pasta dishes, snacks, sandwiches and salad dressings are rich in sodium.

You can’t assume a food has little sodium just because you can’t hardly taste any salt in it. That’s because most foods high in sodium won’t taste salty like pickles do. For example, pastries and sweet cereals are high in sodium but don’t taste salty. Also, some foods are low in sodium but may be consumed in quantities that make them a risky source of sodium (like a slice of bread).

Aspirin to Prevent a Heart Attack?

Scientific evidence shows that taking an aspirin daily can help prevent a heart attack or stroke in some people, but not in everyone. It also can cause unwanted side effects.

According to Robert Temple, M.D., deputy director for clinical science at the Food and Drug Administration (FDA), one thing is certain: You should use daily aspirin therapy only after first talking to your health care professional, who can weigh the benefits and risks.

Who Can Benefit?

“Since the 1990s, clinical data have shown that in people who have experienced a heart attack, stroke or who have a disease of the blood vessels in the heart, a daily low dose of aspirin can help prevent a reoccurrence,” Temple says. (A dose ranges from the 80 milligrams (mg) in a low-dose tablet to the 325 mg in a regular strength tablet.) This use is known as “secondary prevention.”

However, after carefully examining scientific data from major studies, FDA has concluded that the data do not support the use of aspirin as a preventive medication by people who have not had a heart attack, stroke or cardiovascular problems, a use that is called “primary prevention.” In such people, the benefit has not been established but risks—such as dangerous bleeding into the brain or stomach—are still present.

Caution Needed With Other Blood Thinners

When you have a heart attack, it’s because one of the coronary arteries (which provide blood to the heart), has developed a clot that obstructs the flow of blood and oxygen to the heart. Aspirin works by interfering with your blood’s clotting action.

Care is needed when using aspirin with other blood thinners, such as warfarin, dabigatran (Pradaxa), rivaroxaban (Xarelto) and apixiban (Eliquis).

What about people who have not had heart problems or a stroke but who, due to family history or showing other evidence of arterial disease are at increased risk? Is an aspirin a day a safe and effective strategy for them?

Again, Temple emphasizes, the clinical data do not show a benefit in such people.

He adds, however, that there are a number of ongoing, large-scale clinical studies continuing to investigate the use of aspirin in primary prevention of heart attack or stroke. FDA is monitoring these studies and will continue to examine the evidence as it emerges.

‘Real Cost’ of Tobacco

The Food and Drug Administration (FDA) has launched its first public health education campaign—”The Real Cost”—to prevent and reduce tobacco use among at-risk young people ages 12-17. Mitch Zeller, J.D., director of FDA’s Center for Tobacco Products (CTP), explains why the agency is undertaking this effort and how it will work.

Q: Why has FDA launched a youth tobacco prevention campaign? 

A: Tobacco use is the leading preventable cause of disease, disability, and death in the United States, responsible for more than 480,000 deaths each year. But the consequences of tobacco use are not limited to adults. Tobacco use is almost always initiated and established during adolescence. More than 3,200 young people under age 18 smoke their first cigarette every day in the United States—and another 700 become daily smokers. FDA sees a critical need for targeted efforts to keep young people from starting on this path. Reducing the number of teens who start smoking will diminish the harmful consequences that tobacco use has on the future health of our country. “The Real Cost” campaign ads will run nationwide beginning on February 11.

Q: Tell us more about the campaign and its target audience.

A: As FDA’s first campaign to prevent youth tobacco use, “The Real Cost” targets the 10 million young people ages 12-17 who are open to trying smoking or who have already smoked between one puff and 99 cigarettes in their lifetime. These youths share important characteristics that put them at risk for tobacco use. They are more likely to live chaotic, stressful lives due to factors such as socioeconomic conditions; be exposed to smoking by friends and family; and use tobacco as a coping mechanism or a way to exert control or independence. Additionally, many at-risk youths who experiment with cigarettes do not consider themselves smokers, do not believe they will become addicted, and are not particularly interested in the topic of tobacco use. We want to make these teens hyperconscious of the risk from every cigarette by highlighting consequences that young people are concerned about, such as loss of control due to addiction and health effects like tooth loss and skin damage.

Q: How is FDA going to implement the campaign?

A: We’ll use paid advertising to surround teens with the “The Real Cost” message. This includes advertising on TV, radio and the Internet, as well as in print publications, movie theaters and outdoor locations like bus shelters. We plan to reach more than 9 million youths with our messages as many as 60 times a year.

Q: How will FDA know if the campaign is working?

A: FDA is going to evaluate the campaign over time to see if it’s effective. We’re going to conduct a longitudinal study, meaning that we are going to try to follow the same 8,000 youths over a two-year period. We will assess key changes in their tobacco-related knowledge, attitudes, beliefs and behaviors over several years to measure the impact and effectiveness of the campaign. In-person, baseline data collection started in November 2013 in 75 media markets across the country. Ultimately, we want to see if exposure to the campaign is associated with a decrease in smoking among youth.

Q: Is this campaign funded by U.S. tax dollars?

A: No. User fees collected from the tobacco industry fund all FDA’s tobacco-related activities, including educating the public about the harms of tobacco use.

Q. Is this FDA’s only youth tobacco prevention campaign?

A: This initial FDA effort is the first of several distinct youth-focused campaigns being launched in the next two to three years. Other youth tobacco prevention campaigns will target additional audiences such as African American, Hispanic, Asian/Pacific Islander and American Indian/Alaskan Native youths, rural youths, and lesbian, gay, bisexual and transgender youths.

Q: How can I get involved?

A: FDA’s goal is to keep “The Real Cost” campaign authentic through a peer-to-peer approach. The campaign website and social channels are intended for teens. We recommend that adults use and share the materials on FDA’s resource page, including campaign information and customizable resources such as posters, postcards and campaign flyers. All materials are available for free download and many will soon be available for ordering through the campaign’s clearinghouse. Stakeholders who work with youth audiences can help extend the campaign by encouraging teens to share campaign messages with their peers, or by sharing our resources with other youth-focused organizations.

Reduce Sodium Intake!

Most Americans consume way too much sodium, with salt (sodium chloride) being the most common form. That can be a serious health hazard, because excess sodium consumption contributes to the development and escalation of high blood pressure, a leading cause of heart disease, kidney disease, and stroke.

Research shows that Americans consume on average about 3,300 milligrams (mg) of sodium every day. The 2010 Dietary Guidelines for Americans recommends a reduction of sodium intake to less than 2,300 mg daily.

And those age 51 and older, and people of any age who are African-American or have high blood pressure, diabetes or chronic kidney disease should further reduce sodium intake to 1,500 mg daily. This amount meets your essential need for sodium.  These populations comprise about half the U.S. population.

The Centers for Disease Control and Prevention (CDC) recently reported that children and adolescents consume about the same amount of sodium as adults and also risk developing high blood pressure. The researchers found that kids who consumed the most sodium faced double the risk of having high blood pressure, compared to those who took in less sodium. For overweight or obese children, the risk was more than triple.

“There has been a common misconception that sodium intake is just a concern for people with high blood pressure,” says Jessica Leighton, Ph.D., MPH, senior advisor for science in the Food and Drug Administration’s Office of Foods and Veterinary Medicine. “But it’s a health risk for all people, including children, as the CDC report shows.”

FDA is working on a number of fronts to help consumers manage their sodium intake.

Benzocaine Products

Benzocaine products—which are sold as gels, liquids, sprays and lozenges—are also widely used by adults.  Doctors and dentists often use sprays containing benzocaine to numb the mucous membranes of the mouth and throat during such procedures as transesophageal  echocardiograms, endoscopy, intubation, and feeding tube replacements.

Even though children are more at risk, it’s still a good idea to talk to your health care professional about using benzocaine, especially if you have heart disease; are a smoker; or have breathing problems such as asthma, bronchitis or emphysema. These conditions put you at greater risk for complications relating to methemoglobinemia, says Taylor.

FDA advises consumers to:

  • store any products containing benzocaine out of the reach of children.
  • use benzocaine gels and liquids sparingly and only when needed. Do not use them more than 4 times a day.
  • read the label to see if benzocaine is an active ingredient when buying OTC products. Labels on OTC products containing benzocaine are not currently required to carry warnings about the risk of methemoglobinemia.  If you have any concerns, talk to your health care professional before using them.