The patient's perspective

da Emil Tsenov


Life is a risky business.

To implant a defibrillator or not? The patient's perspective

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We must take risks every day in order to lead a meaningful existence. It is unlikely that many of these risks will become dangerous, but the possibility exists, even if it is so small that we pay no attention to it. Every year in the United States approximately 75,000 pedestrians are struck by a car and more than 4000 of them die. We don't take this possibility into consideration but we cross the road because we need to do so, and because we trust the drivers.

Managing risks is part of our existence and we accept it, especially when we know the dangers we face and can be reduced in this way.

Things change when we are faced with a new risk, of which we have neither sufficient knowledge nor the power to manage it, especially when it is communicated to us suddenly. Think about the following situation: you are relatively well and living peacefully, when suddenly your heart starts beating fast. Doctors tell you that you have a genetic heart condition, which may get worse, and you may also have an arrhythmia that can cause cardiac arrest (CA). They suggest implanting a defibrillator (ICD) to avoid it. Doctors believe this may be the best solution, but ultimately the decision is yours. So, what do you think and decide to do?

Here are some suggestions:

  1. Gather information to better understand the situation

Many patients faced with the decision to implant an ICD or not know little or nothing about their heart condition. This is “normal” because it is all very complex, with terms that are difficult to understand. We will all have to trust our doctors (hopefully you are in the hands of doctors with experience in this area, if not, make sure you find them), however we will have to make a careful choice. To collect information there are specialized sites (see, o, the latter in English), or you can consult scientific articles and brochures that you can receive from your doctor and support groups. It must be borne in mind that these support groups are made up of people who come together to share their experiences, usually either very negative or very positive.

  1. Assess the level of urgency

Your doctors should provide you with a detailed explanation of the procedure, the devices to be implanted, and the suggested implant times. Under normal circumstances the decision to have an ICD should not be subject to time pressure. If they tell you that the implant is urgent (it can happen), ask for more details to understand the reasons for this urgency. Do not be afraid that the doctor may resent you, because you are not questioning his professionalism, but simply trying to make the right decision for yourself.

  1. Understand what risk means in general terms and for you personally
  • Risk is a relative concept that refers to probabilities and can vary greatly from one person to another. If, for example, you are a male in your sixties and told that you have a 1% chance of AC in a year, this risk is not much different than that of having prostate cancer. The difference is that it is much easier to imagine “the heart suddenly stopping”. Few of us are able to make an absolutely impartial assessment of our own risks because they affect us personally as well as, in different ways, our well-being, family, finances, personal relationships, our lifestyle, work.

The personal perception of risk depends more than anything else on:

  • Age: adults evaluate risks in a more balanced way, while young people tend to ignore them.
  • Family composition: the perception changes if you are alone or in a family with people who depend on you, and in particular if you have young children.
  • Character: Most of us have a natural tendency to be optimistic or pessimistic.
  • Environment: we are influenced by our culture, our friends, relatives, the media
  1. Understand the consequences of the implant and the possible outcomes

Positive consequences:

  • Constant protection against the risk of AC. Remember that this protection is not absolute and there may be isolated cases where the ICD may not be sufficient.
  • Psychological relief. Many people feel relieved because they feel more protected.
  • More information about the heart. The device continuously collects information and shares it by periodically sending it to the plant center (Remote monitoring).
  • Possibility of stimulation. Transvenous ICDs allow you to control the heart rate if it is too slow (bradycardia) because they can stimulate the heart at the speed deemed appropriate by the doctor or fast (tachycardia), also using specific drugs.

In case of bradycardia, subcutaneous ICDs also make it necessary to implant a pacemaker.

Transvenous defibrillatorNegative consequences:

  • The possibility that the device produces the discharge even in the absence of an arrhythmia that can cause AC (inappropriate download). The efficiency of the device depends on various factors, which allow you to make a shock by interrupting the arrhythmia and avoiding the AC, but this may not happen. In these cases we talk about Inappropriate download. Some studies report a percentage of up to over 13% of inappropriate discharge over time. This does not normally lead to catastrophic consequences, but it can be a traumatic experience for patients and, if it happens repeatedly, even create psychological harm.

If there is more than one shock, you need to go to the nearest hospital immediately.

  • Surgical complications. Implanting an ICD is not complicated, but it depends a lot on the type of ICD. It is more complicated if it is necessary to implant a dual-chamber transvenous ICD or even with resynchronization (CRT-ICD). But with any type of surgery, complications can occur, such as infections and bleeding. The percentage of complications can reach up to 9% while infections are up to 1.5%.
  • Post-surgical complications. In some cases, in subjects with a transvenous ICD, the cables that conduct the stimulus may move or break (leads) and their extraction may be necessary, a complex and sometimes risky procedure.
  • Replacement. As the battery loses power, the ICD needs to be replaced, usually every 7 or 10 years depending on the model and how much it has stimulated or discharged. This means having to operate again to extract the expiring ICD and implant a new one.
  • Foreign object in the body. For many people, the mere idea of ​​having a foreign object inside the body is scary. Then it may happen that the ICD changes position, or you can feel the cables (especially when it is cold) etc. It takes some getting used to and some people never stop feeling it. Many people with an S-ICD are uncomfortable if they sleep on the left side, where the implant was inserted, and this is especially the case in the first few months
  • Your body image. The device may be visible (especially if it is an S-ICD which is larger), when you are at the beach or when you are wearing a tight shirt. Then you can see the scars of the implant.
  • Problems with Magnetic Resonance Imaging (MRI).). Most newer devices allow MRI, but if the leads were implanted many years ago, they may not allow this. In any case, the responsibility for performing an MRI lies with the radiologist, who can refuse it. Usually, before the exam, the ICD must be "inhibited" by the cardiologist, and "reactivated" after having done the exam and leaving the room

Repercussions on:

Subcutaneous defibrillator
sex life. Some people with implants and their partners worry that the device might activate during intercourse, although the likelihood is very low. This can have a negative impact on the couple's sexual life.

travel. It is necessary to inform airport security that you have an ICD and that therefore the person check must be carried out "by hand". It can be risky to travel to very remote areas, without the possibility of being able to check the ICD, if necessary.

work. The presence of an ICD can constitute an obstacle, for example if electricians or mechanics work with tools that can generate significant magnetic fields, such as a drill, or if they have to lift large weights.

Patent. Italian law so far leaves the commissions free to decide, at their discretion, the period of validity of the license, usually for just one year

  1. Understand the alternatives

We tend to think in binary terms: something can happen or not happen. Many of us are also pessimistic by nature. This perhaps comes from the distant times when you had to be very careful in order to survive. In the head it is often simplified: the choice must be made between "implant an ICD or run the risk of dying". In reality there are always three options: 1. Implant the ICD 2. Not implant the ICD 3. Wait and decide a little later, after having thought carefully, and optimize the therapy in the meantime.

Waiting may seem counterintuitive, but there may be benefits, especially in borderline cases when you are unsure whether an implant is needed. For example, you may have more information to decide. Then some analyzes may have given wrong information, so it is better to repeat them to evaluate the situation. Errors are possible. New devices may be available, perhaps with better performance. This sector is constantly evolving by offering smaller and more reliable devices, which may have been improved and, for example, last longer.

Perhaps you will better understand what constitutes an acceptable risk for you and what way of life suits you best. Of course, if you decide to wait you will need to be sure that the option of an implant will always be available in the future (this is normally the case); you will need to agree on a strategy with your doctor and also the times for further analyzes and decisions.

  1. Understand the parties involved in this process and their motivations

Aside from you (the patients), there are other groups who may have an interest in your decisions to implant the ICD. These groups are:

  • Doctors and hospitals. I Doctors who implant an ICD get paid for that too, especially in private hospitals. Then, doctors prefer to be more than scrupulous if there is a risk of AC which can lead to the patient's death. This would lead to negative consequences for their reputation, psychological damage and even legal issues, for which they make you sign all those papers (they are elements to limit the liability of the doctors and healthcare personnel involved).
  • ICD manufacturers. Obviously it is in their interest to sell more devices (i.e. make more implants). The price of these devices is non-trivial, the profit margins are high and globally the industry exceeded 11 billion dollars in 2021. There are predictions that it is expected to grow to 18.2 billion in 2026. Furthermore, it is in their interest that you , or your doctor, choose one of their models, and not those of the competition, if you have decided to have the implant. The models can also be very different and, if you want, you can receive information for this.
  • Private medical insurance. Private insurance companies usually cover all (or almost all) costs of having an ICD implanted, but try to approve the least expensive alternative available in order to minimize costs. This usually does not happen in the National Health Service, as in Italy, in affiliated public or private hospitals.

The interests of these groups are sometimes contradictory and not necessarily in the best interests of the patient. We need to take note of it. A study in 2021 compared thousands of patients with Hypertrophic Cardiomyopathy from the United States and Europe.

The study found that ICDs are implanted much more frequently (more than twice as often) in patients in the United States than in European patients. However, this did not lead to an increase in survival in patients implanted in the United States compared to those in Europe. Furthermore, the rate of appropriate ICD discharges in US patients was much lower than in Europeans. It is possible that this greater availability of the implant is linked to the interests described above and the need to limit the liability of doctors.

  1. The decision must be shared.

But ultimately it is only the patient who can make this decision. There is no doubt that the vast majority of patients would ask doctors to take it and that may be fine, since you have trusted them to protect your health. But that doesn't mean you have to act impulsively; the choice must be made very carefully.

The patient must be sure that he is well informed and has received answers to these questions:

  1. Is implantation of a device “necessary” based on the estimate of a high risk of AC?
  2. Has the reason for this recommendation been clearly explained?
  3. Is it clear what the implant procedure entails?
  4. What are the technical characteristics of the device that will be implanted?
  5. What life changes may occur following the implant?
  6. Do you believe that implanting the device will give you psychological relief?
  7. Will the plant have an effect on jobs and income?
  8. Are you comfortable with the concept of a foreign object inside your body?
  9. Does the recommendation to have the implant also come from a specialist in Cardiomyopathies?
  10. Are you in the physical and psychological conditions to decide to have an ICD implant?

ICD or no ICD - The patient's perspective

It could also be helpful to make a list of all the pros and cons, defining their importance and paying attention to the consequences of the decision, especially in the case of borderline recommendations. It's about your life and also the way you live it!

(translation Prof. Franco Cecchi)