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From the Spring 2004 Issue
Patients Talk
A Clinical Study Helps Two Patients
We interviewed two patients who have benefited from a clinical study in two different ways. Meet Bob Whitney and Judy Honeycutt—both are patients with Guidant products. Bob received an implantable cardioverter defibrillator (ICD) when he participated in the Multicenter Automatic Defibrillator Implantation Trial II (MADIT II). Judy had an ICD implanted after the MADIT II study made it easier for her to get a defibrillator.
The Results of MADIT II
MADIT II helped to show that heart attack survivors treated with a defibrillator and medication may have a reduced risk of death. This result was in comparison to people in the study who only took medications but did not have an ICD implant.
MADIT II also changed how some doctors decide who should receive a defibrillator. MADIT II showed that doctors can recommend an ICD for heart attack survivors based on one test. This test is a measurement of the ejection fraction (EF). EF measures how well your heart pumps blood to your body. Based on this study's results, doctors may look more closely at a patient's EF and consider a defibrillator.
Bob 
Judy |
Bob: MADIT II Study Participant Judy: Benefited From the Results of MADIT II |
What is the history of your heart condition?
BOB: I had my first heart attack the day after my 36th birthday. The doctors think that I've had four other heart attacks since then. I was at a Little League meeting, and my heart stopped for about 4 minutes. Fortunately, a doctor and an FBI agent were also at the meeting. The two of them gave me CPR and got my heart started again.
JUDY: Doctors say I must have had rheumatic fever when I was young and that it may have caused my heart problems. My heart was damaged and doesn't pump as well as a healthy heart. Since the age of 23, I've had four open-heart surgeries.
How did you learn you could benefit from an ICD?
BOB: After I was resuscitated at the Little League meeting, I was rushed to the hospital. I was there for 3 days. I asked my cardiologist what my options were. He introduced me to another doctor, who knew about the MADIT II study. He told me that he thought I would be a perfect candidate for the study. I feel lucky to have a doctor who knew about it. Because of the seriousness of my situation, I was glad to participate in a clinical study. I feel even luckier to have been in the group that received the defibrillator.
JUDY: My doctor said I was at risk for sudden cardiac death. He told me that I needed a defibrillator. I knew that I wanted one if my doctor said I needed it. When you go into sudden cardiac death, there's not a lot you can do unless you have a defibrillator.
How did your doctor prepare you?
BOB: Before the surgery, my doctor did a pretty good job of describing the implant. He explained what it could and could not do. Also, I took a really active role in my health. I asked lots of questions.
JUDY: My doctor took time to go through what I should expect. He gave me pamphlets on ICDs. I also wanted to learn for myself, so I got on the Internet and read everything I could find.
What concerns did you have about the surgery?
BOB: My doctors gave me enough information, so I really didn't have any qualms. They told me that my heart would stop again. I was fortunate to have two people who were able to help me at the Little League meeting. I realized I might not be so lucky next time.
JUDY: My doctor took the time to explain things to me and ease my concerns. This helped prepare me for the surgery. I've always had confidence in my doctor. He explained that I could go into sudden cardiac death. If I didn't get the ICD, I could die. After receiving my defibrillator, I actually went on a tour of Guidant's factory. I was so impressed by how much care Guidant puts into making its ICDs. They check and double-check every step in the process. It gives me added confidence in my own device.
How was the clinical study different from just getting surgery?
BOB: They did a lot of testing to monitor my progress. At first, it seemed time-consuming, but it wasn't, really. It took a few hours every 3 months. Not a bad trade-off. I've always had problems, dating back to the days of my first heart attack. Medicine has helped, but it never got it fully in control. The study gave doctors a chance to treat my condition in a more controlled atmosphere.
Have you needed to rely on your ICD?
JUDY: Yes. After I had the implant, I needed the ICD. As I was working one night, I fell to the floor without warning. I didn't know what was happening. And my husband was asleep. He didn't know that I was in distress. My defibrillator came on and did what it was supposed to do, restarted my heart. If I had not had it, I guess I would have died.
How has your life changed since the operation?
BOB: The ICD gives me a different mind-set. Should something go wrong, I know my device will activate. I had some circulation problems and was unable to walk. That was before I received my ICD. Now I like to keep busy. Activities I enjoy are fishing, coaching Little League, building dollhouses for charity, and seeing my grandkids.
JUDY: I do what I did before. My husband and I garden and also volunteer at the hospital. We're also very involved in our children's lives. My ICD does give me peace of mind. I know that if I need the ICD, it's there—like when my ICD saved my life by activating when my heart stopped. If it hadn't, I would not have been alive to attend my son's wedding.
Note: Individual symptoms, situations, and circumstances may vary. Please consult your physician or qualified health provider regarding your condition and appropriate medical treatment. The information provided is not intended to be used for medical diagnosis or treatment or as a substitute for professional medical advice.