
1. How serious is the risk of sudden arrest? Sudden cardiac arrest is a leading cause of death each year. Your risk depends on the heart abnormality you have. Discuss your risk with your physician.
2. Is sudden cardiac arrest the same as a heart attack? No, a heart attack happens when there is vessel blockage or coronary artery disease. This prevents enough blood from getting to specific areas of the heart, causing a heart attack. Sudden cardiac arrest is when there is an electrical problem with the heart. A severe heart attack may put you at risk for the development of a life-threatening arrhythmia which can lead to sudden cardiac arrest. For more information, visit www.HRSonline.org.
3. What causes an arrhythmia? Arrhythmia is usually caused by a problem with the electrical system of your heart. Life-threatening arrhythmias include ventricular tachycardia (VT) and ventricular fibrillation (VF).
4. What is the difference between VT and VF? Ventricular tachycardia or VT is an abnormally fast heartbeat, beating more than 100 beats per minute, compared to a normal heart rate of 60 to 100 beats per minute. VT can turn into ventricular fibrillation or VF. When the heart beats so fast, more than 200 to 300 beats per minute, it shivers or trembles instead of pumping blood to your brain and body. With VT or VF, you may lose consciousness.
5. What are the symptoms of sudden cardiac arrest? Some of these symptoms may come before sudden cardiac arrest, but often there is no warning.
- Fatigue or weakness
- Shortness of breath
- Fainting
- Dizziness or lightheadedness
- Heart palpitations
- Chest pain
6. How does the Cameron Health S-ICD System work? Just as your physician places wires on your chest to monitor your heart during an electrocardiogram or ECG, the S-ICD System similarly monitors your heart with a wire just under the skin. The S-ICD System is the only implantable defibrillator that uses an ECG-like signal to monitor your heart for abnormal rhythms that indicate sudden cardiac arrest. The S-ICD system is designed to accurately treat sudden cardiac arrest when you need it, and it may also reduce the likelihood of receiving unnecessary shocks.
7. What is the difference between the S-ICD System and a traditional ICD? The S-ICD System is the only implantable defibrillator that does not require electrical wires in your heart. The S-ICD System is implanted using a completely subcutaneous procedure that leaves the heart and blood vessels untouched and intact. By placing the electrode just under the skin, the S-ICD System eliminates potentially serious short- and long-term risks associated with placing electrical wires inside your heart or blood vessels.
8. How does a shock restore my heart rhythm? When the S-ICD System senses a dangerous heart rhythm, it will send an electrical pulse to your heart to reset your heart’s normal rhythm and allow your heart to resume pumping blood through your body.
9. What does a shock feel like? People have reported a wide range of experiences as a result of receiving a shock, from a mild thump to a kick in the chest. While the shock may be painful, this means your S-ICD System is monitoring and responding to dangerous heart rhythm irregularities.
10. Is defibrillation dangerous? ICDs are a safe treatment option that have been used for decades and have prolonged hundreds of thousands of lives. Without defibrillation, if your heart beats too quickly, you may experience sudden cardiac death. There are risks associated with implantation. Talk to your physician about those risks.
11. Are there risks associated with traditional ICDs? Like any other medical device implanted in the body, there are some risks, such as infection and bleeding. These include leads that are implanted directly in the heart, complications with lead wires, lead failure, vein complications, and removal of leads. Other risks associated with implantable defibrillators include delivery of inappropriate therapy. Your physician is the best source of information about the risks of traditional ICDs. Be sure to talk with your physician about all your questions and concerns.
12. What are the risks associated with the S-ICD System? The S-ICD System has been designed to reduce complications associated with traditional ICD electrical wires. However, the S-ICD System implantation, like every surgical procedure, does carry risks, including infection and bleeding. As with any ICD, there is a risk of delivery of inappropriate therapy. Your physician is the best source of information about the risks of having the S-ICD System. Be sure to talk with your physician about all of your questions and concerns. The S-ICD System is investigational in the United States. In the United States, the S-ICD System is only available at hospitals participating in an FDA-approved clinical study.
13. How is the S-ICD System implanted? During the procedure, your surgeon will make three incisions. First, a small incision is made on the left side next to the rib cage where the pulse generator will be placed. Then, two small incisions will be made slightly to the left of the breastbone for the electrode. Once the S-ICD System is programmed, your physician will close the incisions to complete the procedure.
14. Are S-ICD Systems available worldwide? Yes, currently they are available in Europe and as an investigational device in the United States. The S-ICD System is only available at hospitals participating in an FDA-approved clinical study in the United States.
15. Can I enroll in the clinical trial? The clinical trial is only open to qualified candidates in the United States. Call 1-877-SICD-411 to talk to one of our Cameron Health US Customer Service Representatives for enrollment and eligibility information.
16. Will I be able to feel the implanted Cameron Health S-ICD System? Many people are aware of their implanted S-ICD System, but quickly become used to it over a short period of time.
17. Can I participate in physical activities such as running, skiing, and sexual intimacy? Generally, the S-ICD System is compatible with an active lifestyle. After your recovery, your physician will advise you on when you can get back to your regular activities.
18. How does the system know not to shock me when my heart is beating faster, such as when exercising? With highly advanced technology, the S-ICD System is designed to detect the difference between increased heart rates due to exercise and dangerously fast heart rhythms due to ventricular fibrillation (VF).
19. How often will I get shocked? Therapy delivery varies for each patient and depends on your specific heart condition. For each instance of sudden cardiac arrest, a single therapeutic shock will be delivered to restore the heart’s natural rhythm. After a shock is delivered, the S-ICD System will continue to monitor your heart and deliver an additional shock if needed.
20. Will I be able to travel with the S-ICD System? Your physician or nurse will give you a Cameron Health Patient Identity Card (ID card) after the procedure. This ID card lets people know you have a S-ICD System and provides medical device, implant date, and physician information. Be sure to carry your card to alert healthcare professionals and airport security about your device. If you plan to travel and don’t have a Patient ID card, you can print a temporary card, and show other forms of identification to airport security. The card has six languages that help explain that your device may trigger airport security alarms.
21. What do I do if I get shocked? Consult your physician on what to do if you receive a shock.