SCAA's Ask the Experts Online Forum A Live Interviews Online Site Powered by Forum One http://discuss.suddencardiacarrest.org/ Tue, 09 Mar 2010 23:10:08 +0100 SyntaxCMS via FeedCreator 1.7.2 Prescription Medication Adherence: What it Means for Heart Failure Patients http://discuss.suddencardiacarrest.org/content/interview/detail/843/
Winston:
In the healthcare reform debate, I keep hearing that many heart failure patients return to the hospital shortly after they have been discharged. Is this due to not properly taking medication?
Dr. John Rogers:
There are a number of reasons why a heart failure patient may return to the hospital shortly after being discharged. Noncompliance with diet (eating too much salt) or medications certainly accounts for a large number of these patients. In some instances a patient’s heart failure is so bad that they frequently return to the hospital for intravenous medications.
Jimmy:
Between the stress from watching the Super Bowl and eating my wife’s gumbo, I had some chest pain that I assumed was just heartburn. Now I pretty much feel back to normal, but how do you know the difference between heartburn and something more serious?
Dr. John Rogers:
Sometimes it is difficult to tell if a discomfort a person is feeling is from the heart or from the stomach or esophagus (heart burn). Typical heart pain is usually described as a heaviness or pressure like sensation in the center of the chest (like someone pushing or standing on your chest). This discomfort can be very mild or quite severe. Sometimes typical heart pain or pressure will radiate up into the neck/jaw and into the left arm. Occasionally typical heart pain will also involve, shortness of breath, nausea, sweating, lightheadedness or feeling faint. Occasionally a person can have atypical symptoms (some type of discomfort other than the above) and it can still be there heart.

Certainly a good batch of Gumbo and watching your favorite Team (the Saints I assume) battle it out in the Superbowl can cause heartburn from too much stomach acid production HOWEVER it is always a good idea to get yourself checked out if you have had any chest discomfort. I urge you to let your doctor know about your symptoms. Your doctor may recommend for you to have an EKG and/or a stress test just to be sure.
Dwight:
I’ve had a heart arrhythmia since childhood and I’m now 28. I heard in the news that an ablation technique shows better results than some arrhythmia medicines. Is this true for most people with common arrhythmias?
Dr. John Rogers:
Certain heart rhythm problems can be treated and in fact cured by an ablation procedure. In some cases medication can be significantly reduced and even stopped after the ablation. Because each type of heart rhythm problem is very unique and each has different success rtes from ablation I urge you to discuss this with your doctor. The ablation procedure is performed by a highly specialized cardiologist (know as an electrophysiologist) who sub specializes in treating heart rhythm disorders with this type of procedure.
Mary:
I've been taking a low-dose aspirin each day for the past three years. I guess I think of it as a vitamin because it's an over-the-counter drug. My husband thinks I should discuss this with my doctor, but I don't see the need. We agreed to let you be the referee. Is this something I need to raise with my doctor?
Dr. John Rogers:
It is always a good idea to discuss the use of any medication (over the counter, supplement, vitamin or prescription) with your doctor. There are a number of benefits to taking low dose aspirin however taking it daily is not completely without risk. This risk mostly coming form the gastrointestinal tract in the form of irritating the lining of the stomach or esophagus, causing heartburn and even slightly increasing the risk of gastrointestinal bleeding.

In my practice, if there is no history of cardiovascular disease I recommend a low dose aspirin as part of a daily regimen if a patient has one or more risk factors for developing cardiovascular disease (high blood pressure, diabetes, high cholesterol, smoking, family history of cardiovascular disease). This low dose aspirin is in addition to whatever medications they may need to address their other risk factors.

If a person has cardiovascular disease then a low dose or regular strength aspirin will likely certainly be a part of their daily regimen.

AS your “referee” I would suggest you discuss this with your doctor so that he/she may advise you and so that it can be placed in your medical record that you are taking aspirin, an important fact that other health care providers might need to now in the future while caring for you.
Dan:
I only get my blood pressure checked once a year during my annual physical, yet blood pressure is one of the heart numbers that patients are advised to monitor in order to maintain a heart-healthy lifestyle and reduce risks of cardiovascular conditions. Is there a convenient, non-intrusive way that I can more frequently monitor this, aside from the machines at the grocery stores?
Dr. John Rogers:
If someone has normal blood pressure the current recommendations are for an annual screen of blood pressure. If someone has high blood pressure they will likely be evaluated numerous times throughout the year. As long as your blood pressure has always been normal the yearly exam should be sufficient. However, if you are at all concerned and want to know your blood pressure or have other risks for developing cardiovascular disease (smoking, diabetes, high cholesterol or a family history of stroke or heart disease then I would recommend getting an automatic blood pressure machine and checking your blood pressure 3 – 4 times a year. These portable blood pressure machines are affordable (generally less than 100$) and very easy to use.
Lorraine:
I take Crestor for cholesterol problems, and I read that the FDA recently approved expanded use of the drug. What other conditions can Crestor be used for, and does that mean it could replace various other drugs?
Dr. John Rogers:
Based on the results of the JUPITER Trial, which involved 18,000 patients the FDA recently voted to expand the indications for the use of CRESTOR. CRESTOR already has an approved indication to lower cholesterol and triglycerides in combination with diet and exercise in patients with high cholesterol and/or triglycerides, and an indication to slow the progression of atherosclerosis.

The new indications include:
Primary Prevention of Cardiovascular Disease
In individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease based on age ≥50 years old in men and ≥60 years old in women, hsCRP ≥ 2 mg/L, and the presence of at least one additional cardiovascular disease risk factor such as hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease, CRESTOR is indicated to:
• reduce the risk of stroke
• reduce the risk of myocardial infarction
• reduce the risk of arterial revascularization procedures

This new indication in no way is meant so that Crestor can replace other medications. The exception to this might be if you are on another statin medication and are questioning whether or not you should switch to Crestor. In this case I would ask your doctor.
Barbara:
I’ve read the guidance about “knowing your numbers” and “getting to goal.” I’ve been on a brand name statin for almost two years. It hasn’t made any difference in my cholesterol level. I’ve asked my doctor about changing medication or going to a generic to save some money, but she insists on staying the course. I almost feel like she’s getting some rebate from the drug manufacturer. How do you suggest I talk to her to get a better outcome?
Dr. John Rogers:
I always tell my patients that the best statin drug is the one that works (gets their LDL Cholesterol to goal) and is covered under their insurance. We as physicians who treat high cholesterol have our favorite statin usually, one that we know that most of the time is going to work to lower cholesterol. We may feel that one is stronger than the other or in our experience has been more successful in lowering cholesterol. One of the driving factors in my practice has been cost and which statin is covered under patients insurance. I may have to work with increasing doses or switching to a different statin until I find one that lowers the cholesterol to goal in a given patient.

I will say however, that in my experience, certain name brand statins or combination drugs (statin and another medication combined into one pill) work better than most generics to lower cholesterol.
I would encourage you to make an appointment to discuss this specific issue with your doctor. Let her know that the cost is becoming prohibitive and you wish to switch to another statin.
Ellen:
Does it really make a difference if I occasionally miss a dose of heart disease medication? I’ve been on medications in the past for other conditions, and missing a dose every once in a while didn’t seem to have a negative impact.
Dr. John Rogers:
For the most part it can definitely make a difference if you miss a dose of heart medication. Depending on the medication and the problem being treated (high blood pressure, heart rhythm problems, need for blood thinners) missing one or more doses can lead to problems. Unfortunately doubling up on medications because you missed a dose can also be dangerous. It is always best to consult your physician if you miss a dose or are having trouble remembering certain doses during the day. When discussing this with your physician be certain to ask the question, what do I do if I miss a dose of this medication?
Thank you for joining me today. That concludes this session of SCAA's Ask the Experts with Dr. John Rogers.]]>
Dr. John Rogers Fri, 26 Feb 2010 16:00:00 +0100
How comparative effectiveness research and other aspects of health care reform will affect you http://discuss.suddencardiacarrest.org/content/interview/detail/808/ For more information, please read the newest edition of Power Points here: http://associationdatabase.com/aws/SCAA/asset_manager/get_file/12170

Or visit the Partnership to Improve Patient Care at www.improvepatientcare.org.]]>
Fri, 04 Dec 2009 17:00:00 +0100
Clinical Trial Proves Effectiveness of Cardiac Resynchronization Therapy in Slowing Heart Failure http://discuss.suddencardiacarrest.org/content/interview/detail/786/
Cindy:
According to the American Heart Association, it appears that the field of cardiology will be negatively affected by potential Health Care Reforms. Will any of the reform measures in Congress affect the FDA’s approval of this study and its findings?
Dr. Arjun Sharma:
The proposed payment cuts in cardiology will affect health care providers such as cardiologists. The FDA should not take this into consideration as patient safety and effectiveness of therapy are the main concerns of the FDA.
Judita:
Can physicians already use these devices in the general public or are they only still being used in clinical trials?
Dr. Arjun Sharma:
The ICDs used in the MADIT-CRT trial are all market released devices approved for use in patients indicated for ICD therapy. The CRT-D devices used in the MADIT-CRT trial are FDA approved for use in patients who meet the current CRT-D indication, which means they fall into NYHA Class III/IV and therefore have advanced symptoms of heart failure. However, the MADIT-CRT trial looked at patients who have not reached the advanced symptoms of heart failure. Boston Scientific will likely be using the data from this trial to seek an “expanded indication” for all market-approved CRT-D devices to include the MADIT-CRT population.
Peggy:
Does this mean that patients with ICDs will need to get them replaced with CRT-Ds?
Dr. Arjun Sharma:
Even though the MADIT-CRT study results are positive new indications for CRT-Ds in patients in the NYHA Class I/II categories, this type of treatment has not yet been approved by the FDA for heart failure patients in Class I/II. The study will be published and examined by the FDA before a decision is available. In the future, if a person meets the criteria of the MADIT-CRT study then it is likely that those patients will be upgraded to a CRT-D device once FDA approval is received.
Tucker:
If CRT-Ds are different than regular ICDs, can I still exercise, swim, garden, and pretty much do the things I enjoy? Or are there unique limitations to the CRT-Ds?
Dr. Arjun Sharma:
CRT-Ds are different than regular ICDs. Specifically, CRT-Ds work with every beat of the heart to create a resynchronized contraction, which may increase exercise capacity AND provide the protection of an ICD. ICDs on the other hand, provide pacemaker support when called upon to do so and also provide protection from sudden cardiac arrest (SCA). Exercise has been shown in general to benefit patients with a variety of heart conditions. However, as every patient is unique, it is important to check with your physician about how much exercise is safe, and what types of exercise are appropriate.
Cynthia:
If this study has demonstrated a slowing of heart failure in Class I and Class II patients, what about those people in the Class III and Class IV categories? Does this type of treatment work in them as well?
Dr. Arjun Sharma:
Yes, CRT-D is beneficial for patients with a wide QRS (ECG), reduced heart function (ejection fraction less than 35 percent) and NYHA failure Class III and IV. These results have been demonstrated in a previous trial titled COMPANION and approved CRT-Ds have been approved by the FDA for usage in NYHA Class III/IV patients. The new finding is that preliminary results suggest that high-risk patients with mild heart failure (Class I/II) benefit from early intervention with cardiac resynchronization therapy.
Mark:
This study has proven to slow the progression of heart failure – what exactly does this mean? What is happening in the body to slow the progression? Are certain symptoms decreased, are patients not readmitted to hospital as often?
Dr. Arjun Sharma:
MADIT-CRT preliminary results indicate that CRT-D therapy is associated with a significant reduction in the risk of death or heart failure intervention when compared to ICD therapy. Additional information on the study results will be published in the future. We do know that heart failure is a progressive disease where over time a patient’s clinical status declines. An analysis provided by Dr. Parag Jain in the February 2003 supplement of American Heart Journal discusses the progression of heart failure with each acute event further impacting a patient’s clinical status. Therefore, reducing hospitalizations in heart failure patients greatly impacts patient outcomes.
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Dr. Arjun Sharma Wed, 12 Aug 2009 19:00:00 +0100
Cardiac Rehabilitation: The Key to Living Again After Sudden Cardiac Arrest http://discuss.suddencardiacarrest.org/content/interview/detail/747/
Scott:
Is there an increased risk of another SCA after a vigorous exercise routine is established?
Leni Barry:
A major risk factor for any cardiac event is exercising at a level your heart is not accustomed to. The purpose of cardiac rehabilitation is to slowly and deliberately increase the intensity of exercise in a monitored environment. In addition, the goal is to set limits on the intensity to keep you within a safe range. It is clear that having one SCA increases one’s risk of a second and that is why defibrillators are often inserted (a device most like a pacemaker, which has the added capability of identifying, and by means of an internal shock, converting the heart to a normal rhythm).
Margaret:
How much supervision is there of participants in Cardiac Rehab? My only fear of starting the exercise portion of the program is placing that stress on my heart especially if I'll be left alone.
Leni Barry:
Margaret, you are never left alone during the entire cardiac rehab program. You will be checked in by rehab staff, making sure it is appropriate and safe for you to exercise that day. Then your heart rhythm and heart rate will be monitored on a screen, by staff while you exercise. Staff will check your blood pressure during exercise and be available to work with you to adjust your settings or answer any questions or concerns.

After your exercise, you will cool down and staff will check your blood pressure and heart rate, clearing you to go. Also during exercise you will have the opportunity, if you choose, to talk with other people who are exercising as well.

The purpose of rehab is to exercise your heart in a monitored safe environment. They will slowly advance your settings while monitoring your vital signs to eventually get you safe and ready to exercise independently. The process is slow and thorough.

For cardiac rehab to be most successful, it requires open communication between staff and patients. Make sure to discuss your concerns, that‘s what they are there for.
Mark:
How does weightlifting compare to aerobic exercise in cardiac arrest patients?
Leni Barry:
After cardiac arrest, developing an exercise program is a powerful part of an individual’s recovery. Since each person has a different set of circumstances related to their cardiac arrest, it is very important to have a personalized exercise prescription written for you. This is designed by your Cardiac Rehab Staff, and approved by your Cardiologist who referred you into Cardiac Rehab.

First I am going to back up and explain aerobic and anaerobic exercise, and how your body uses energy. Aerobic describes a type of metabolism, or how your body breaks down stored fuel to create energy. Your body can create energy aerobically, with direct oxygen, or anaerobically, without direct oxygen. The food you eat is where your energy comes from. This energy is stored in your body as fat, in your muscles and liver. The bloodstream carries oxygen to cells and these cells transform the stored fat into energy, releasing the energy. The higher your demand of energy, the higher the demand of oxygen to release this energy.

The process of using oxygenated blood to release energy is called aerobic metabolism. Aerobic exercise is an activity that involves a steady, continuous motion of the large muscle groups. This places a large continuous energy demand on the heart. These increased demands on the heart, cause it to grow stronger and more efficient. Some examples of aerobic exercise include walking, jogging, swimming, bicycling, and dancing.

Anaerobic metabolism fuels short bursts of activity, such as weight lifting or sudden sprinting, when your body requires energy faster than the cardiovascular system can provide to it aerobically. Anaerobic exercises can build both muscle strength and endurance.

So, weight lifting is an anaerobic exercise. It is an essential part of a total fitness plan; however it does increase your blood pressure and can sometimes be inappropriate depending on your cardiac situation. It would be best to have a consult with your cardiologist about weight lifting and your heart. If you are cleared, then developing a specific program with a Cardiac Rehab Staff and being monitored initially would be the next step.

Aerobic exercise is beneficial after cardiac arrest because with the gradual increase of oxygen demands on the heart muscle, it helps to build a stronger, more efficient circulation. It improves the body’s ability to deliver oxygen rich blood to the rest of the body. This is very important to help your energy level and stamina, which affects your quality of life.

Great question Mark, I hope that was helpful.
Barry Horowitz:
What diet recommendations do you have for someone recovering and trying to avoid relapse?
Leni Barry:
Eating a heart healthy diet is one of the most important steps you can take after a cardiac event, when trying to avoid a relapse. What you eat effects many risk factors associated with a healthy heart: your cholesterol levels, your blood pressure, your weight, and your blood sugar level. So learning how to incorporate a heart healthy diet is beneficial to us all.

The “Dietary Guidelines for Americans” offers these recommendations for heart healthy eating.
-Choose a variety of grains daily; half of your daily grains should come from whole grains.
-Choose a variety of fruits and vegetables daily.
-Choose a diet that is low in saturated fat, trans fat, and cholesterol.
-Choose foods and beverages that are low in added sugar.
-If you drink alcoholic beverages, do so in moderation.
-Aim for a healthy weight.
-Be physically active most days.
-Balance the calories you take in with the calories you expend through physical activity.
-Keep foods safe to eat.

These are great basics for heart healthy eating. If you have high blood pressure or high cholesterol, you may need some additional changes in your diet. You may want to work with a registered dietitian to help make these changes. A dietitian can design a specific program for you including calorie intake, choosing foods, help to track your progress and offer encouragement through this process. Ask your doctor about getting a referral, or your Cardiac Rehab Staff. In the meantime here are a few resources, and there are many great heart healthy cookbooks out there. Have fun exploring!
NHLBI Health Information Center: 301-592-8573
NHLBI Heart Health Information Line: 1-800-575-WELL (provides toll free recorded messages)
Heart Healthy Recipes:
www.nhlbi.nih.gov/health/public/heart/other/syah/index.htm
http://www.nhlbi.nih.gov/health/public/heart/other/ktb_recipebk/
Marge:
I had a heart attack in April 2008. I participated in a cardiac rehab program that I found very useful, and I continue to utilize the exercise program three times a week. But I can't bring myself to exercise in a non-hospital setting. I would like to play golf once in a while or join my friends on their daily walking routine, but I can't seem to get comfortable with "unsupervised" exercise. Any advice?
Leni Barry:
Great job Marge! Completing cardiac rehab, and continuing in the maintenance program, is something to be proud of. The feeling you are describing is very common and there are several strategies and tools you can use to help your comfort level in “unsupervised” exercise.


1. Know Your Exercise Prescription Goals-Talk to your rehab staff. Tell them your goal for exercise outside of rehab and review your exercise prescription. Every participant of rehab has their own specific exercise prescription that has been designed for you and been approved by your cardiologist. This prescription has target heart rate, MET level and duration parameters set just for you. You should use those parameters when exercising on the outside. So you need to be comfortable in your method and abilities to measure your target heart rate. You need to determine, with the help of the staff, the MET level of the activity you are interested in doing. And you need to keep in mind the duration goal when planning your outing.

2. Measure your Perceived Exertion –The “Rate of Perceived Exertion (RPE) Scale” is a scale from 6-20 (Borg scale) that measures your perception of difficulty of the activity, your overall body exertion. This is commonly used in rehab as a tool when determining exercise intensity levels. Get a copy of this scale from rehab and use it in your activity. A score of 6 indicates the same exertion as sitting and resting in a chair. A score of 11 is considered light exertion, a score of 15 is hard, and a score of 20 is maximum exertion that you can do no more. An exercise goal on the RPE scale should be between 1-16. If your score is higher than 16, you should decrease the intensity of your exercise.

3. Stay within your Target Heart Rate-Whether you take your pulse or use a heart rate monitor, check your heart rate. You should check your heart rate at rest before you exercise, during peak moments of your exercise and at the end. Stay within your target heart rate range.

4. Monitor yourself for Symptoms-Just like in rehab; if you have symptoms during exercise you stop the activity and rest. If you have been prescribed Nitroglycerine tabs, bring them with you and be confident in how and when to use them. If you develop shortness of breath beyond your norm stop the activity and rest. There are more factors in the outdoor environment then in an indoor exercise room – such as temperature, quality of air, hills, etc. So be smart in choosing the time of the day and check the weather for air quality and humidity.

5. Never Exercise Alone-It’s always safer to exercise with someone or where others are around.

6. Carry a Cell Phone-If you are not in an area that has a phone nearby, it is always safer for you to have a charged phone. Also it is smart to have your doctors’ numbers programmed in, as well as family.

Being prepared with the knowledge and tools on how to keep within your safe range should help give you some confidence to take one baby step at a time. Remember there is nothing wrong with taking it slow, and talk about it with your rehab staff as questions or concerns comes up. Have fun!
Eugene:
I am very self-conscious about my weight, and reluctant to exercise in front of others. Despite the best efforts of the staff, I did the bare minimum to complete my rehab program. I know I need to stay in a exercise routine, but need some help. I live alone. Is walking on a treadmill in my home a good option?
Leni Barry:
Eugene this is a common concern that comes up. And it can be tough. Not knowing the specifics of your heart health, I must say in general exercising alone with a history of heart disease or SCA, is not the safest approach. I believe in safety first and exercising alone has risks.

Most community hospitals host programs such as Mall Walking, where it is a safe environment, not affected by the weather conditions. Joining a gym and going during off hours when it isn’t busy is another idea. It’s best if someone is around in case you ever needed help. You are not the only person in your rehab or area with this concern, so ask your rehab staff for local resources. You are not alone.
Susan:
My husand survived a cardiac arrest about 18 months ago and received an ICD. Once he was able to, he joined a rehab program that he found very helpful, both physically and psychologically.But as a spouse, I sometimes feel a little helpless in trying to provide support. And I also felt like sometimes I needed support. Is there a version of cardiac rehab for spouses?
Leni Barry:
Susan, what a great idea! Over the years we have had situations when a spouse wanted to join rehab because they saw how much it helped their loved one. Life style changes are a family affair so it is important to treat and teach the family. The exercise component of cardiac rehab is not covered by insurance for family members, however, several lifestyle counseling components of our program and others are. Spouses are welcome to participate with their loved one during the nutrition counseling, stress management counseling, diabetic teaching, Heart Health educational classes, and cardiac support groups.

I love your idea. Each rehab and hospital has different programs offered. Bring up your interest and need to the rehab staff and community outreach department at your local hospital. Maybe they can start a walking group for spouses or a support group. Everything starts with an idea.
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Leni Barry Mon, 18 May 2009 14:00:00 +0100
Federal Preemption and Sudden Cardiac Arrest http://discuss.suddencardiacarrest.org/content/interview/detail/720/
Christopher L. White answered questions on the topic of federal preemption. White is the executive vice president and general counsel at the Advanced Medical Technology Association (AdvaMed). In 2007, he was the first recipient of the PricewaterhouseCoopers Award for Leadership in the Advancement of Ethics in the Medical Device Industry.
Jess:
Can you explain the process that the FDA goes through to approve a medical device? Are there ways to improve the process, rather than changing the law(s)?
Christopher White:
Preemption applies to devices that have gone through the PMA process which accounts for less than 2 percent of devices approved by FDA each year. These devices undergo the FDA’s premarket approval (PMA) process of scientific and regulatory review evaluates for safety and effectiveness. This is the most rigorous device approval process undertaken by the FDA. In the PMA process, The FDA spends an average of 1,200 hours to review each PMA submission. Once a device is approved through the PMA process, the manufacturer is required to report annually to the FDA on any changes to the device and provide a summary of any new information about the device from scientific literature, unpublished reports and any other sources. Manufacturers must also collect and report all information on certain adverse events related to the device to the FDA.

The entire process for regulating and approving all medical devices is extremely complex; there are three classes of medical devices, and they are subject to different standards and varying methods of review.
Rebecca:
How do national physician groups such as AMA or ACC stand on preemption? Have they taken a position?
Christopher White:
National medical groups have generally not taken a position on the medical device preemption issue to date.
Lamont:
I have an ICD, but it is not one that has been the subject of recalls, etc. over the past several years. I have heard radio advertisements from law firms looking for people with ICDs to join class-action lawsuits. Under what laws are those people suing the manufacturer, and how would a change in the law impact that?
Christopher White:
If you have questions about the health information that you hear in a personal injury lawyer advertisement, consult with your doctor. Under no circumstances, should anyone make personal healthcare decisions solely based only on what you hear in an advertisement.

For decades, patients have been able to sue and recover damages from a medical device manufacturer. Nothing about the Supreme Court’s decision changed that fact.

Patients can recover damages if a product was manufactured improperly or if the manufacturer misled or withheld information from the FDA regarding the safety and effectiveness of the product.

The proposed law would allow patients to bring lawsuits against device manufacturers for risks warned against in the product’s FDA-approved label for devices that have gone through the PMA process which accounts for less than 2 percent of devices approved by FDA each year.
Gina:
I'm a manager with a local EMS agency. How does law apply to AEDs that are approved by the FDA? Most of the discussion was about devices for patients -- what about devices used by hospital and emergency medical agencies?
Christopher White:
Preemption applies to medical devices that have been through the Premarket Approval (PMA) review process, including devices that are used by healthcare providers, like AEDs. The FDA categorizes medical devices into three classes The PMA review process is for Class III devices which receive the highest level of scrutiny in order to assure safety and effectiveness. Preemption applies to devices that account for less than 2 percent of devices approved by FDA each year.
Cindy:
So my husband has an ICD with the Fidelis leads that were recalled. He's not had any problem with them. How does the law as currently written impact his legal rights? What about if Congress changed the law?
Christopher White:
While we can’t furnish you with legal advice, we can address the policy aspects of your question.

Since the Medical Device Amendments were enacted in 1977, patients have been able to sue and recover damages from a medical device manufacturer. Nothing about the Supreme Court’s 2008 decision changed that fact.

The proposed law would allow patients to bring lawsuits against device manufacturers for risks warned against in the product’s FDA-approved label for devices that go through the FDA’s most rigorous device approval process, and currently enjoy limited legal protection for submitting to this process.

If Congress changes the law, juries/courts essentially will establish separate device approval and labeling standards -- potentially for the same product.
Sandra J.:
I understand the argument that the FDA has the expertise, but sometimes even the experts are wrong. We have people afraid to eat peanut butter, and last year, the FDA scared everyone about eating tomatoes when the they had nothing to do with the salmonella outbreak. Did the FDA file a petition with the Supreme Court? Have they testified in front of Congress or taken any formal position to elaborate on why the law shouldn't be changed?
Christopher White:
There is no institution, public or private, that can’t be made better— the FDA included. But for more than 30 years the current system for regulating medical devices has worked to balance patients’ needs for new treatments against the risks inherent in any device. The current law also provides for FDA-approved warning labels to ensure that patients and physicians can make informed decisions about the risks and benefits of every device.

Regardless of the recent food safety issues, the FDA’s decisions about medical devices are driven by valid scientific data. It is a process that cannot be replicated in a single state, or in any courtroom.

On behalf of the FDA, the Solicitor General filed the government’s amicus brief (a legal filing common in Supreme Court cases that allows individuals and organizations not directly involved in a case to share views with the Court) in support of upholding express preemption for PMA devices. The amicus brief argued, in part, that removing preemption will weaken FDA at a time when Congress has invested hundreds of millions of dollars to make the agency stronger.

Congress gave FDA the authority to oversee medical device approvals with the Medical Device Amendments of 1976.
That concludes our interview today. Thanks to Christopher White and all our participants. This has been a great discussion.To learn more about this discussion, view the latest issue of Power Points HERE.]]>
Christopher White Mon, 23 Feb 2009 19:00:00 +0100
Sudden Cardiac Arrest and Sports http://discuss.suddencardiacarrest.org/content/interview/detail/684/
Dr. Christine Lawless, a member of the SCAA Medical Advisory Board, is a recognized leader in this field as a researcher, author, and medical practitioner. Formerly Associate Professor of Internal Medicine at The Ohio State University Medical Center, she now has her own practice and consulting business in sports cardiology. Dr. Lawless hosted this "Ask the Experts" session on SCA and sports.
Rosanne:
My son died in April, collapsing after he ran the 400 meter race at the N. Andover MA track meet. I want the school to approve heart screening, but the school committee wants a cardiologist at the next meeting for them to consider it. How do I get a cardiologist who is sympathetic to screening to come out at night to a school committee meeting?
Christine Lawless, MD:
I am very sorry to hear you lost your son. If you are looking for heart screenings to be approved, find some like-minded people to join you in your efforts. Then, find a cardiologist who is most likely to be sympathetic to young people. I’d suggest one who has children, or has volunteered as a coach. A pediatric cardiologist may also be more likely to come out to assist. If you call large cardiology groups, you may be more likely to find someone willing. My other suggestion is that you work toward providing a voluntary program that encourages students to be screened at a reduced or no cost, rather than mandating the screenings. Once school officials and parents see the value of the program, they are more likely to repeat or expand it in future years.
bob:
Are there any recent definitive studies regarding pm 2.5 (i.e. forest fire smoke) as a trigger for cardiac arrest?
Christine Lawless, MD:
Lots of studies correlate particulate matter (air pollution) as a trigger for cardiac events. Regarding forest fires specifically, people with prior history of myocardial infarction (MI, heart attack) are at increased risk for a second MI during a forest fire. Knowing that SCA is often caused my acute MIs, I would have to say the answer to your question is “yes”.
Marcus:
Despite the false results that may occur, do you think testing athletes should be a requirement?
Christine Lawless, MD:
At this point, I would have to say no. See item number 8 where I discuss extensively for Rick.
Joan:
Hi Dr. Lawless, my son Mike went into cardiac arrest 2 years ago. He survived after a long battle, has an ICD, lives on 2 heart pills a day and had Hypertrophic Cardiomyopathy. He recently shared with me that he often feels unbalanced. Not dizzy and he does not fall. Do you think there could have been a little damage to his central nervous system?
Christine Lawless, MD:
Hi Joan. It is so wonderful that Mike survived! Dizziness is problematic for physicians because it can have many causes. Before thinking this was related to the central nervous system, I’d wonder about the following: Is it related to medication? Is the pacemaker portion of the ICD “kicking in”, causing brain to feel the difference in the amount of blood ejected by the heart from the artificial beat of the pacemaker? It is certainly something to discuss with Mike’s doctors, especially those who check his ICD.
Laura:
I have a three-year-old son who is gene positive. His father passed away of HCM at 27. Currently, his heart is normal. He is a very active child. Do you think sports activity should be avoided prior to changes in the heart or would it be OK for him to play until we detect a change? Also, what activities would be best for him to be involved in?
Christine Lawless, MD:
We have two opinions of this subject. One from our US group of experts, who say he should be allowed to play until the disease becomes apparent (seen on echo or MRI), and another opinion from the European group of experts who are more conservative on this issue, and say that play should not be allowed. As he is likely to show signs/symptoms of the disease at some point, I’d let him play now, before he unequivocally needs to be restricted. There is a nice paper from Circulation on genetic diseases in young people. It states that things like bowling, golf, swimming laps, brisk walking, and moderate biking are probably all allowable, even after phenotypic expression (appearance of the disease on echocardiogram or MRI).
Jo Anna:
My husband died suddenly at age 36 from cardiac arrhythmia while playing football with his buddies. One of our sons now has the same genetic heart defect that my husband had - ryanodine receptor. Now our 5 year old son wants to play soccer, but his pediatric cardiologist doesn't want him to. Yet he was allowed to play T-Ball. Where should I draw the line with what I let him do? I don't want to keep him from living a full, fun life. We carry a pediatric defibrillator with us when we know he is going to be active, in case of emergency by the way...).
Christine Lawless, MD:
Hi JoAnna! You probably already know this is somewhat rare and we are learning more about it in recent years. There is little information regarding how much activity, but I think we need to approach it like a right ventricular cardiomyopathy. In this case, I think the pediatric cardiologist is correct. Soccer would be a high dynamic sport, and probably way too much for this type of disease. You may wish to seek an opinion from those who have published on this subject. The T-ball may also be a bit too much. The Circulation article I mentioned above (in question 1) says brisk walking only. The other consideration is that you want him to get involved in activities that he can continue as he gets older, rather than taking away things he loves. So sports like golf provide that lifetime opportunity.
Terri:
Could school nurses and others administer the ECG to help lower the cost? Where is real “cost” of a broad-based testing program? I guess I don’t understand why we wouldn’t want to have every child have at least one baseline ECG at some point. We have requirements for vaccinations and other health care programs, like the new HPV vaccine for teenage girls to protect them from cervical cancer.
Christine Lawless, MD:
Please see my reply to Rick for more elaboration. But the cost of an ECG is $50-$75. I would call that “retail”. The cost can be decreased by getting volunteers to perform the ECG (provided they could implement a high quality test.) getting already paid employees such as school nurses to do the testing (a lot of work as each ECG takes 10 min to do, and physicians are still needed to interpret) renting the ECG machine, and paying for paper (about $1 per student/athlete/patient), I’ve done screenings using this approach and the cost can come down to about $10 per test. However, given a school of 3000 student, screening of the entire student body could cost up to $30,000. The reason HPV vaccine may be required is that studies have shown it to be very effective. To date, we do not have a well-controlled prospective study in the US showing the same for ECG screening. I hope this explains some of the apparent confusion in recommendations.
Rick:
I'm surprised that the NCAA doesn't require screening of competitive athletes. I see that you were at Ohio State. Did they screen athletes? If yes, what was the motivating factor that got them to implement a program? If not, why not?
Christine Lawless, MD:
The NCAA as an institution does not endorse the routine use of ECGs and/or echocardiograms. Nonetheless, some of its member institutions have chosen to go this route, some for many years. The University of Wisconsin and Purdue are some of the ones that come to mind. I worked at Ohio State University and did oversight for the cardiac portion of the pre-season screening program. Our program consisted of the 12 element AHA history and physical, incorporated into the main pre-season evaluation. We did not do ECGs or echocardiograms in all the athletes, only those in whom a “red flag” was raised by the 12 element history and physical. We did not choose to do ECGs and ECHO because strictly from the view of evidence-based medicine, there are several unanswered questions regarding routine screening with ECG and/or echo.

One cannot say with certainty that adding the cardiac diagnostics adds something beyond the H and P alone. Most people point to the Italian study of cardiovascular screening and how there was a concomitant decline in the sudden cardiac death rate over a 20 year period after ECG was added to the screening program. However, this was not a randomized prospective study. Thus, not the best kind of study. Also the initial death rate before ECG screening was quite high, and after ECG was implemented is similar to what the US has experienced for many years. Thus, we cannot say we would see the same decline in the US if the issue was studied properly here. It’s tempting to extrapolate the Italian data to our population, but we are genetically different, and what applies in Italy may not apply here. In addition, although ECG and ECHO are “decent” tools to detect hypertrophic cardiomyopathy (HCM, number one cause of SCA in athletes) both tests are either inadequate at predicting or not so good at detecting number two and three causes of SCA in athletes (commotio cordis and anomalous coronary artery respectively). ECG detects 75% of asymptomatic HCM. Thus it is entirely possible to miss a substantial number of HCMs in those athletes without symptoms. Thus, those who undergo such screening may be left feeling overly certain that screened athlete has no heart disease when in reality, the athlete may still be at risk. I do not object to screening. However, it is important to know what to do with the information and to let the athlete and parent know screening is never 100% reliable (possibility of false negatives). Lastly, athletes can have false positives. This can be problematic, as approximately 10-40% of athletes may require further cardiac evaluation, causing delay in athlete returning to play.
John:
My kids have participation restrictions due to Long QT. We have them involved in sports like tennis and golf which has worked out well for the older one, but the 14-year-old often resents not being able to do other things his friends do. We've tried to emphasize the positive and focus on the many things he CAN do, but would appreciate your advice on good reading material or talking points you have found helpful in dealing with teenagers.
Christine Lawless, MD:
Teens can have tough time not doing what their friends are doing. They may not be open to reading either. I think what helps is that all folks who care about the teen, like parents, coach, friends, physician, school nurse, and athletic trainer communicate with one another and provide the same message. If the teen hears it consistently from everyone that recommendations are being made for his/her own wellbeing, then the teen may be more likely to accept the recommendations. Also, while they may not be able to play aggressive basketball, or compete in swimming, they can certainly find something else to do like be team manager, or keep track of scores. This may help him/her feel included.
Mary V.:
There seems to be pretty compelling evidence that AEDs are effective in responding to SCA in public places, including sporting events, health clubs, etc. How can a school district, youth sports league, etc. afford NOT to implement an AED program? It seems more and more like they are putting themselves at risk for failing to have a simple tool readily available to respond to SCA.
Christine Lawless, MD:
There seems to be pretty compelling evidence that AEDs are effective in responding to SCA in public places, including sporting events, health clubs, etc. How can a school district, youth sports league, etc. afford NOT to implement an AED program? It seems more and more like they are putting themselves at risk for failing to have a simple tool readily available to respond to SCA.
That concludes our interview today. Thanks to Dr. Lawless and all our participants. This has been a great discussion.]]>
Christine Lawless, MD Wed, 03 Dec 2008 14:00:00 +0100
The Disparity of Care in SCA http://discuss.suddencardiacarrest.org/content/interview/detail/647/
SCAA hosted an "Ask the Experts" session with Dr. Kevin Thomas of the Duke University Medical Center, who responded to questions about this and related issues regarding improving cardiac health care for women and minorities. Dr. Thomas was a cardiovascular fellow and was honored with the Ralph Snyderman, MD, Graduate Medical Education Research Award while serving his residency at Duke. Since joining the Duke Medical staff, he has lead research in several areas related to the subject of health care disparities.
peppermintpatty:
I had my ICD installed in April 2008. I used to do a cardio work out at the gym in which I would push my heart rate between 134-150 for 30-45 minutes. Now I am on a Beta Blocker and my heart rate cannot reach the Cardio zone. My question is whether exercise at a lower heart rate has cardio benefit? If I never exercise at 135-150, will my heart become weaker. I notice that I do not have the stamina to do prolonged exercise. Its a problem for me, but is is a problem for my heart?
Kevin Thomas, MD:
For many patients who have an ICD a beta blocker is an important medicine to strengthen the heart, prevent recurrent heart attacks, control blood pressure and to prevent abnormal heart rhythms. Exercising regularly is an important part in keeping your heart strong. Despite your heart not achieving the rates it did before the medicine was initiated you are still having significant cardiovascular benefit and it is unlikely your heart will weaken because of this observation. It is common to experience a decrease in your stamina when the beta blocker is initiated but that should improve once your body acclimates to the medication.
michaele:
My Mother recently died from SCA. Could she have been saved if someone knew CPR?
Kevin Thomas, MD:
The answer to your question is not straightforward. SCA accounts for 335,000 deaths annually. 36-81/100,000 out of hospital cardiac arrests are treated by emergency medical services. So many SCA’s are unwitnessed and thus lead to poor outcomes.

Only 6% of SCA survivors live to be discharged from the hospital, so even if they are found and brought to the hospital survivors are relatively uncommon.

Given these considerations it is hard to know whether CPR or emergency services could have changed the outcome. During SCA time is of utmost importance and the quicker someone is found the better their chances of survival. The other variable is what caused her sca some conditions are more treatable and responsive than others.

It is important to recognize that your mother’s situation places you at higher risk and it is important to discuss this consideration with your doctor.
Jack:
What percentage of SCA victims actually suffer a heart attack (MI)?
Kevin Thomas, MD:
Myocardial infarction (heart attack) is one cause of sudden cardiac arrest.
According to the Heart Rhythm Society 75% of patients who die of SCA show signs of a previous myocardial infarction.
Noreen G.:
I really don’t have a primary care physician. I see my OB-GYN for my annual check-up, and she also does a physical exam and standard lab work but not an EKG. My mother and father both had coronary artery disease, but I’ve always just assumed that it was due to poor eating and exercise habits. Do I need to consult with a heart specialist?
Kevin Thomas, MD:
If you have a family history of coronary artery disease, particularly if it was diagnosed in your parents or other first degree relatives (mom, dad, brother or sisters) before the age of 55 that is a risk factor for you. In my opinion an EKG should be a part of your annual exam at least every 3-5 years. Many OB-GYNs are general practitioners but given your family history I would suggest having an internist see you annually to assess your risk and to perform the necessary screening tests not necessarily a cardiologist.
Mark:
I work at a community health clinic. Language barriers are a big issue, and we are often relying on children to interpret for their parents. The clinic has a policy of not allowing any “branded” material from medical corporations which might promote a certain brand of drug or company. If the AMA or the government really wanted to make a difference, developing a good library of information in some foreign languages would be of tremendous help. Do you have any thoughts on this?
Kevin Thomas, MD:
Language concordance is paramount in providing high quality health care to minority populations. Unfortunately far too often there are situations such as those you describe. This is increasingly recognized as a problem and organizations such as CMS/JCAHO are requiring clinics and health systems to consider this issue and to provide better resources. The impetus for enforcing bi-lingual learning materials and staff resources must come from the stakeholders of the health system to ensure this change is widespread.
Mary L.:
I’m an African-American woman, active in the business community and my church. I sometimes feel inundated with messages about how African-Americans are at “higher risk” for a variety of health care issues (prostate cancer, breast cancer, heart disease, diabetes, etc.). Are we at “higher risk” or “under treated or under diagnosed?”
Kevin Thomas, MD:
All of the above. African Americans are at higher risk for many of the conditions above and also diabetes mellitus, obesity, renal disease, and the list goes on. African Americans are also plagued by heath care disparities that manifest as lack of access to heath care providers, no insurance, less likely to receive care by subspecialists, and to receive the latest, newest medications and procedures. These disparities lead to worse health outcomes. That being said, there are opportunities for African Americans to improve their health by exercising more, improving eating habits, and focusing on a healthy lifestyle.
Linda:
My husband’s father died nearly 30 years ago at a young age (47). I did not know him and no one seems to have all the details of his death, but it has always been described as he died of a “massive heart attack in his sleep.” As I learn more about sudden cardiac arrest, I of course look at my husband and our three children and worry about their risks. All three of our boys play competitive sports. I have thought about getting them a cardiac screening but it doesn’t seem to be something other parents are doing and it has never been brought up by coaches or the school. My husband thinks I’m just being overly cautious so I would be interested in your thoughts.
Kevin Thomas, MD:
The details of the death of your husband’s father are very important. If in fact he had SCA as a result of a myocardial infarction or heart attack that is very different than if he had SCA without evidence of heart blockages or a heart attack. In any event it is important that your husband have routine annual physical exams that tests him for diabetes, checks his cholesterol, and maintains a healthy lifestyle with exercise and good eating habits. In regards to your children, their risk is largely predicated on your husband’s and your genes. If your husband died suddenly that would place them at a greater risk, The issue of screening children who participate in competitive sports for cardiac abnormalities remains controversial. Overall the risk of SCA is extremely low (chance of occurrence is 1 out of 100,000).

The American Heart Association recommends a more cardiac-specific exam involving an EKG, echocardiogram or stress test for patients (even student athletes) who meet one of these criteria:

Personal history of syncope (fainting) or near syncope, excessive shortness of breath or fatigue, chest pain, hypertension, family history of unexplained or premature sudden cardiac death, hypertrophic obstructive cardiomyopathy or dilated cardiomyopathy, Marfan’s,Syndrome or Long QT Syndrome, an exam that detects a notable pathologic murmur, brachial-femoral delay, Marfan’s stigmata, or hypertension.

I also think it is important to have an Automated external defibrillator at all games.
Carolyn:
My sister has high blood pressure and her doctor says she’s a “borderline” diabetic. I’ve tried to get her in to see a specialist, but she insists that the general practitioner she has seen for almost 40 years is the only doctor she trusts. Maybe if he referred her to a specialist she would take his advice, but that hasn’t happened. Any advice?
Kevin Thomas, MD:
Your sister’s situation brings up several important issues. Your sister seems to have a lot of trust and faith in her general practitioner which is an important part of her health care. Individuals who have that type of relationship with their physician tend to be more compliant with their medications and adherent to a healthy lifestyle. This is only helpful if her general practitioner is treating her appropriately and telling her the right things to do. With hypertension and borderline diabetes, her general practitioner should be capable of managing these diseases. A specialist is not always needed in these circumstances. Given that she has these risk factors it may be reasonable to refer her to a cardiologist for a cardiac work up if she is having symptoms or is at an increased risk of significant coronary disease based or her risk profile which her GP should be able to discern. If she is not following the recommendations of her GP I think it is unlikely a specialist would be more successful.
Jose:
Please help with some advice on how to talk to my wife about her health. She is 64-years old. She had what her doctor called a “minor” heart attack about three years ago. She has cut back on her smoking but still smokes, and rarely exercises. She says she “feels fine” but I can see that she is often out of breath after climbing a flight of stairs or similar activity. Since nagging about changing lifestyle habits doesn’t work and she doesn’t bring up these issues with her doctor, I’m hoping you have some other suggestions.
Kevin Thomas, MD:
This is difficult; denial and is a common theme among many people. Perhaps you can motivate her by telling her how important it is for her to change her lifestyle because you want to have her around to enjoy life with of for her grandchildren or children if appropriate. Using other people is sometimes a good motivator. You need to be willing to exercise with her. She needs to stop smoking, as even one cigarette a day is dangerous. Also you may want to try support groups in the community or with friends. Testimonials are often very influencing hearing other individual’s story. Stay with it despite the frustration, your love and support will help in the end
Miguel:
As a 29 year-old, healthy male, what basic questions should I be asking my doctor about my heart and its health? I have a heart murmur, but want to be sure that I'm not at risk for other heart disorders. I think heart failure runs in the family -- my dad had a heart attack at age 49, but didn't have any indication that he was at risk.
Kevin Thomas, MD:
Your father’s history certainly puts you at risk. Preventative maintenance will be key for you. You should be screened annually for cholesterol, diabetes and hypertension. You want to reduce the number of risk factors that you have for developing heart disease. And since you can’t change what happened to your Dad you must focus on the things you can change. Diet and exercise are important. Heart murmurs are typically fairly common in young patients and shouldn’t be a big concern, That withstanding if your physician is concerned about the character of your murmur a cardiac ultrasound (echocardiogram should be obtained.
Sandy:
As a student, sometimes it is difficult to eat a balanced, heart healthy diet. What are the best foods to eat to avoid potential "heart issues"?
Are there particular foods to avoid altogether?
Kevin Thomas, MD:
I can appreciate your situation; busy with school and not a lot of financial resources, and it can be much more expensive to eat healthy. Try to avoid eating fried foods every day all things in moderation cut it back to 1 day every other week .Baked or steam foods are much healthier. Most college students get into trouble because they snack frequently. Snack on fruits and vegetables instead of candy bars, and potato chips. Trail mix is also a good alternative.

Lastly incorporate exercise into your regular routine.
Norma:
My husband and I are in our early 50s. We participate in a HMO so don't have a strong relationship with any particular personal physician. We both have been given similar advice at our most recent annual check-up:
quit smoking, lose weight, exercise more and reduce sugar/salt in-take.
Blood pressure, cholesterol and blood sugar are "elevated" but nothing too alarming according to the doctor. I know you can't give specific medical advice to complete strangers, but I'm hoping you can give some general advice. Where do we start? Quit smoking first? Exercise? Diet? Trying to tackle it all at once seems too overwhelming. I think if my husband and I work together on a plan that is achievable, we are likely to be more successful, but I don't know how to proceed.
Kevin Thomas, MD:
Not knowing the specifics of your respective test results I would offer the following.

Stopping SMOKING should be the highest priority. This is by far and away the worst thing about your health and should be stopped ASAP. There are now many ways to assist with this including using medication.

Exercise again is important. Start slow with walking a few times a week for 30 minutes and advance to 5 times a week which is currently recommended.

Diet can be an extremely effective way to lose weight, and improve your test results in all categories. Again try starting small cutting out all of the sugared drinks in your diet you will be amazed at the results

Good luck.
That concludes our interview today. Thanks to Dr. Thomas and all our participants. This has been a great discussion.]]>
Kevin Thomas, MD Mon, 11 Aug 2008 13:45:00 +0100
Adjusting to your ICD http://discuss.suddencardiacarrest.org/content/interview/detail/555/
Dr. Farkas is a clinical health psychologist and the founder and director of Chicago Behavioral Health (www.chicagobehviorialhealth.com) where he works with patients in the areas of weight management and cardiac risk reduction. He also serves as a consultant to the Electrophysiology Section of the Northwestern Memorial Hospital's Division of Cardiology.

Dr. Farkas, thank you for participating in this forum. We can go right to the first question.
Rick G.:
Your study indicated some different types of adjustment, with some people concerned about a shock, and others concerned about the physical appearance of the ICD. Those are two very different concerns. What are the best coping mechanisms for each?
Howard S. Farkas, PhD:
For people concerned about getting a shock, relaxation techniques such as deep breathing and progressive muscle relaxation may be helpful in coping with anxiety that often comes with such anticipation. Many commercial cosmetic products are very effective in concealing scars. But there are also coping mechanisms that are appropriate for both problems. For example, people have a natural tendency to focus on the negative aspects of a situation, without balancing them against the positives. Healthy coping for any concern, including those related to ICD adjustment, includes the ability to put a problem in its proper perspective and remind yourself of the positives as well. In this case, remember why you have the device in the first place: it’s there to save your life.
Len S.:
I found that after experiencing shocks from the ICD, I was actually less anxious. I knew it worked, and I knew that it was important for me to have it. Do other patients feel the same way?
Howard S. Farkas, PhD:
Your response to the shock is a good example of the type of healthy coping that I referred to above. Many patients report that it removed any doubt that they may have had about whether the ICD would actually work when they needed it, and they felt more relaxed afterward. In addition to that, some patients report that it was a relief when “the other shoe finally dropped” and they realized that the anticipation of what a shock might feel like was much worse than the actual experience.
Mel G.:
My wife received an ICD in November, which was implanted after multiple medical evaluations and careful evaluation by her. She doesn't like to talk about it with others, but insists that she's fine with it. I want to respect her wishes, but also want to be there if she wants to talk about something. Any advice?
Howard S. Farkas, PhD:
I think you’re handling it exactly as I would recommend, as long as you’ve communicated clearly to her that you’re there to listen if she changes her mind and wants to talk. Everyone needs to deal with things in the way and at the pace that works best for them. It may be different from how you would do it, but if it works for her, you can’t impose your own timing or coping methods on her. I would add that, as you appear to realize, sometimes people just need someone to listen, not to fix the problem. Unless she asks for advice, don’t give in to the urge to offer it. Usually, that has more to do with the need of the helper to “do something.” Offering a sympathetic ear is actually doing a lot.
Dave R.:
I don't know why, but I was reluctant to get a remote monitoring system. I guess I didn't want the daily reminder on the bed stand when I woke up every morning. But I finally took my doctor's advice and I have to admit that the system works great. Have you noticed any changes in adjustment patterns as patients use new technology like the remote monitoring systems to provide some added peace of mind?
Howard S. Farkas, PhD:
In our clinic, we haven’t really had enough experience yet with the remote monitoring systems to be able to comment on adjustment patterns over time. But what you describe sounds a lot like how many people typically react to getting an ICD, with the initial reluctance, the daily thoughts about it, and then accepting it as part of their life.
Mary L.:
Hello Doctor Farkas. I received my first ICD in 1987 at the age of 35. Over the years I've seen varying anxiety levels of ICD recipients and have (casually) witnessed the difference between "psychological anxiety" (emotionally based) and "physiological anxiety" (initiated by the brain's physiological "panic" response to low oxygen levels in the blood). Did your study look at those blood gas numbers as contributors to a patient's ability to adjust to an ICD?
Howard S. Farkas, PhD:
Actually, our study didn’t look directly at anxiety at all. We used preoccupation, defined as daily ICD-related thoughts, as a surrogate measure of adjustment. We felt this was a more useful metric because adjustment difficulty could be manifest in a variety of ways, ranging from clinically significant anxiety or depression, to simply worried thoughts. It’s also a simple and practical way for providers to do a quick bedside assessment of psychological adjustment during routine follow-up appointments.
Jennifer W.:
I'm a 36 year old female. I've had an ICD for three years. I identify completely with the issue of some younger women being more self-conscious about the ICD's appearance. For example, I haven't been to the beach in 3 years. My kids don't understand why I won't play with them at the pool anymore. Any suggestions on how to cope? I'd like to get over this reluctance.
Howard S. Farkas, PhD:
Thank you for asking this, Jennifer, because this is the most important message I can offer to you and anyone with an ICD who has similar concerns. You view the scar or bump as a source of shame and something to hide from others. But this discounts the positive, life-affirming statement that having the device represents. That scar is your declaration that you chose to do something that quite likely will extend your life so that you can enjoy doing those things that make life worth living – like going to the pool with your kids! Avoiding those activities defeats an important part of the purpose of having an ICD. If anyone asks about the scar, you can tell them exactly that. After you conquer the pool, take that spaghetti-strap dress out of the closet and go for a whirl on the dance floor!
Rebecca M.:
Generally, I'm okay with my ICD, but once in a while, I find myself feeling like a victim, and I don't like it. Do you have any suggestions for good reading material to help in managing health issues?
Howard S. Farkas, PhD:
I agree with the ideas that Dr. Arthur Barsky talks about in his book, Stop Being Your Symptoms and Start Being Yourself. He takes the approach that how you think about your symptoms, pain, or chronic health condition has a great deal of influence over the degree of discomfort and distress that you experience from it. In fact, that difference can be significantly greater than the effect of prescription medications on those feelings – without the side effects! The book teaches coping mechanisms that are effective in helping you change the type of thinking you describe.
Kristen M.:
I've raised the notion of a patient support group with my EP, but she said her and her colleagues tried one several years back and there wasn't much interest. In your opinion, what are the elements of an effective support group? I'd like to pursue this some more, but feel I need a better understanding about what a support group would actually do and what support it could provide to patients.
Howard S. Farkas, PhD:
Support groups can vary widely in how they are run and what the members discuss, but the common element they all offer is the opportunity for a group of people to discuss a concern they all share. This can be very helpful when someone feels that “unless you’re in my shoes, you just won’t get it.” That may not be true, but the perception of feeling understood is critical to anyone dealing with a concern. In our support group, we have found that the most helpful aspect is for new ICD recipients, or those who had their first shock, to meet and hear from the “veterans” about how they’ve managed and gotten through some early difficulties that they are now experiencing. For their part, the “veterans” get a lot out of telling their story and being able to help.
Rendell R.:
Do you ever get used to the ICD and does it get less 'sensitive' to touch? Original ICD placed in June 2007 and re-placed after Medtronic's lead replacement in December 2007. The second placement resulted in more sensitivity around the area and sharper pain when bumping the ICD.
Howard S. Farkas, PhD:
This question was similar to Linda's who wrote: "I'm a 37 year old woman with an ICD. At times, I find the ICD very painful and sore. Is this something that is normal and do you think it could get better? I have had the ICD for one year."

I'm going to try to respond to both of these here. First, I hope you have shared these concerns with your physician who implanted the device and oversees your follow-up care. But in general, tolerance of pain and sensitivity varies a great deal from one individual to the next. According to our EP nurse, Julie Schmidttiel, this type of experience is fairly uncommon. In her experience, it seems to be more common among women and thin people than men or people who have more soft tissue in that area. It may occur if the device is pressing against a nerve, or if a nerve was in some way affected by the procedure. Some people complain of sharp shooting pains and others may be more sensitive to touch. If the pain is frequent and disruptive of your normal activities, you may want to get a referral to a pain management specialist. Chronic pain management is a growing specialty area for many clinical health psychologists. If it is transient, and is not severe, the brain tends to accommodate over time in the same way that people who live in the city stop hearing the noise of traffic. It would also be a good idea to keep a log to see if there may be a pattern or correlation between certain activity and pain. Sensitivity to exercise, touch, or spontaneous pain all may point to different causes.

Noreen G.:
I am a 40 year old woman. No previous history of cardiac disease. Diagnosed with Idiopathic Ventricular tachycardia with history of storm (many successive episodes of arrhythmias). No history of syncope/SCA. THANK GOD! I had an ICD placed in October and was rehospitalized two days later with Pulmonary Emoboli and Ventricular Tachycardia. Rehospitalized twice more after two more episodes of Ventricular Storm. The ICD fired appropriately with both incidents – first i5 times, and second 3 times. The last episode was at the end of November 2007. When will the post traumatic stress disorder symptoms go away? I am still having nightmares about "firing." I wake up crying. Just finished re-certifying in CPR with AED and had to excuse myself twice for fear of crying in the class. Being startled with microwave sound or beeping noises has improved. Also, would you be able to send me your full study? Thank you.
Howard S. Farkas, PhD:
Studies suggest that for most people, it’s not having the ICD itself as much as the experience of shock that contributes to psychological distress. For those who have experienced an ICD storm, which is more than two shocks in a 24-hour period, that distress is multiplied and symptoms of post-traumatic stress disorder (PTSD) are fairly common. The experiences you describe – nightmares, crying, exaggerated startle reaction, and avoidance of potential triggers – are all very consistent with the diagnosis of PTSD. As opposed to typical adjustment reactions, PTSD does not usually go away with time. Treatment for PTSD requires professional counseling, and the approaches that show the best results use a combination of cognitive behavioral techniques such as exposure (the opposite of avoidance) and stress inoculation (anticipating trigger situations) to overcome the symptoms. You can find a referral in your area by going to locator.apa.org and looking for a therapist who specializes in the treatment of PTSD.

Sorry I can’t send you the study – the version summarized in the SCAA newsletter was a poster presentation at a national cardiology conference. But we do hope to publish a new analysis using a larger set of data in the future.
Carolyn:
Dr Farkas' article states it takes six months before you "adjust". I have had my ICD for five years, it has never "fired" and I think about it every day at least once a day. I think about it whenever I am around electromagnetic devices, even holding my laptop too close to my chest while it is on worries me. I wish I did not think of it as often, though "awareness" of it might be different than "thinking of it". It took me almost a year before I accepted it...but I'm not quite sure I fully accept it. I have concerns over the bulge, but I wear clothes that cover it - my implant was done on a slant so that a bathing suit strap covers it. Even when the bulge shows, no one notices (I've asked) and I am slim so it sticks out a lot. People just don't look there. (Especially men :-) Whenever I feel like a victim, I remind myself I'm a Survivor of Sudden Cardiac Arrest, not a victim. The victims, unfortunately, are no longer with us. I've had some therapy and using Cognitive Behavioral Therapy (CBT) helps a lot. It's all how you think. Support groups are excellent...especially for the first year. They make you realize you are not alone. There are a lot of questions the first year.
Howard S. Farkas, PhD:
The kind of daily awareness you describe sounds very much like what we are referring to in our study. One way to look at it is to compare it to how much you think about other body organs. Do you think about your pancreas or liver on a daily basis? Probably not, unless you’re having a problem with it. Similarly, if you’re not having any problems with your ICD or your heart, there’s no reason to spend any mental energy on it. As you correctly point out, it’s all how you think; life’s too short to spend time, energy, and focus on things you have no control over. Instead, trust that your device will work as designed, and if it needs your attention, it will let you know. Meanwhile, focus on enjoying life.
Jose:
I normally hike with Boy Scouts and my left backpack strap just goes over my ICD. Is there any protector to cover that area of the chest? Is it necessary? Should I just let the strap to go over that area of my chest without concerns?
Howard S. Farkas, PhD:
This is another subject where I consulted with the nursing staff here at Northwestern. I am told that this is very common when there is direct pressure on the site of the incision and device. It’s really just an issue of comfort, though – it does not affect the workings of the ICD. Any extra padding can help prevent or relieve this discomfort. Some people even use padding for their seat belts in the first few months after implant. If you’re placing any heavy load directly over the device, it should be padded, especially when you’re in motion for a long period, like on a hike. Naturally, it would be best if you can avoid carrying a load over that spot in the first place.
Leslie:
My father had SCA in 2006, now has a Medtronic ICD. A year spanned the initial SCA with his first shock with his ICD. Since then, he has experienced regular shocks for no apparent reason. Is there an expert he should be seen by (other than his cardiologist)? He lives in Montana and is willing to travel to see a specialist who has seen this condition before. We just don't know where to turn. He is very active (maybe too active?) and I think he worries about getting a shock. I wonder if there is medication he could take to ease his worries? Any experience with using biofeedback with ICD patients? Any help would be appreciated.
Howard S. Farkas, PhD:
It’s very natural that not knowing what’s causing the shocks would cause concern, but my nursing colleagues don’t think medication would be the answer. The best course would be to find out what is causing it. There is a reason– it’s just a question of figuring out what it is. If he is very active, the detection threshold on the ICD may be set too low for his level of activity. In such a situation, the normal speeding-up of the heart rate during exertion may be read by the device as an arrhythmia. Rather than changing your dad’s activity level, they may simply change the device’s detection level. I would recommend that your father see the electrophysiologist who implanted it, or if that’s not possible, any EP who is nearby. Beyond that, he really should be going in for follow up visits every three to six months. If he lives in an area that’s too distant to go in for regular appointments, he may want to ask about getting a remote monitoring system which will allow interrogation of the device without a face to face visit.
Dave R.:
I don't know why, but I was reluctant to get a remote monitoring system. I guess I didn't want the daily reminder on the bed stand when I woke up every morning. But I finally took my doctor's advice and I have to admit that the system works great. Have you noticed any changes in adjustment patterns as patients use new technology like the remote monitoring systems to provide some added peace of mind?
Howard S. Farkas, PhD:
In our clinic we’re just beginning to enroll patients in the remote monitoring program so we don’t have enough experience yet to see clear patterns. Our patients now have a choice of using it or not, and after a 3 to 4 month adjustment most seem to get used to it and like the idea of not having to come in for their appointment and choose to continue with it. But, not surprisingly when you have a great nursing staff like ours, some people prefer the face to face contact and personal connection that the visit allows.
That concludes our interview today. Thanks to Dr. Farkas and all our participants. This has been a great discussion.]]>
Howard S. Farkas, PhD Sun, 04 May 2008 20:00:00 +0100