Leadless Pacemaker

A leadless pacemaker is a capsule-shaped device that, unlike a conventional pacemaker, needs no lead and no pocket under the skin. It is about the size of a large vitamin capsule and is placed directly inside the heart through the vein in the groin. There is no incision in the chest, no scar and no restriction on the arm. It does not suit every patient, though; which kind of pacemaker is needed is decided by the type of rhythm disorder you have.

Why Is a Pacemaker Fitted?

The heart has an electrical system of its own. The natural pacemaker in the right atrium starts the impulse, which travels along the conduction pathways to the ventricles, and the heart contracts.

If that system slows down or is interrupted, the heart does not beat often enough. Less blood reaches the brain and the other organs. A pacemaker supplies the missing impulse from outside so that the heart works at an adequate rate.

The Commonest Reasons

• Bradycardia: the heart rate slowing to the point where it cannot meet what the person needs.

• Sinus node disease: the natural pacemaker tiring. The pulse sometimes slows a great deal, sometimes pauses.

• AV block: the impulse from the atrium failing to reach the ventricles. A pacemaker is needed in advanced degrees of block.

• A slow pulse together with atrial fibrillation: the rhythm irregular and the pulse pausing for long intervals as well.

• A conduction problem after a valve procedure: some patients need a permanent pacemaker after procedures such as TAVI.

Which Symptoms Are a Warning?

• Fainting, or nearly fainting

• Dizziness, greying of vision

• Marked weakness and tiring easily

• Breathlessness on exertion

• Mental fogginess, absent-mindedness

These should not be put down to age or tiredness and left. An unexplained faint in particular is something to investigate with a rhythm recording.

How Is It Diagnosed?

• ECG: it can show a slow rhythm or a block at that moment.

• Holter monitoring: where symptoms come in episodes, the ECG in the clinic can be normal. A longer recording catches the pauses.

• Event recorder: where episodes are infrequent, devices that record over longer periods can be used.

• Echocardiography: the structure of the heart and its pumping strength are assessed. That information is used in deciding which kind of pacemaker suits.

• Blood tests and a review of your medicines: some medicines slow the pulse. Where there is a correctable cause, that is dealt with first.

Is There a Correctable Cause Before a Pacemaker?

This section is not in most sources, yet it is a question worth asking. Not every cause of a slow pulse is permanent.

The main correctable causes of bradycardia:

• Medicines: some taken for blood pressure and for rhythm can slow the pulse markedly. Adjusting the dose can bring it back to normal. Do not stop your medicine yourself; your doctor makes that assessment.

• An underactive thyroid: the pulse can recover once it is treated.

• Disturbances in the blood: a high potassium level in particular can slow conduction.

• Sleep apnoea: some of the pauses seen at night can be due to apnoea.

• Temporary conditions: conduction problems that appear during some infections and acute illnesses can settle.

Where one of these is present, it is addressed first. If the slowness is not due to a correctable cause and is causing symptoms, a pacemaker comes onto the table.

What Is a Leadless Pacemaker?

A leadless pacemaker combines the pacemaker and the electrode in a single capsule. “Leadless” means that there is no electrode lead.

The device is placed directly on the inner wall of the right ventricle and held there by small tines. It delivers the impulse from where it sits. Because there is no lead, the problems that come from leads do not arise with this method.

How Does It Differ from a Conventional Pacemaker?

The two do the same job by different routes.

• A conventional pacemaker: a small pocket is made under the skin below the collarbone and the pacemaker is placed there. Electrode leads run from it through a vein to the heart. A small scar is left on the chest.

• A leadless pacemaker: no pocket is made and no lead is used. The capsule goes in through the vein in the groin and is left inside the heart. There is no incision in the chest.

That difference in design has practical consequences: problems relating to the pocket, and a lead breaking or moving out of place, do not arise with a leadless pacemaker. There is no restriction on your arm movements afterwards either.

Against that, a conventional pacemaker has an advantage a leadless one does not: it can pace more than one chamber together. That is why the next section matters.

Can Anyone Have a Leadless Pacemaker?

No. Where some sources say it suits every patient, that is not correct, and the most important information on this page is here.

The leadless pacemakers in common use are single-chamber; they pace only the right ventricle. Where the atrium and the ventricle need to work in step, that may not be enough. Dual-chamber leadless systems are being developed but are not in widespread use.

And if CRT is needed for heart failure, or an ICD for a life-threatening rhythm disorder, a leadless pacemaker does not meet that need.

Where It Is Considered First

• Blockages in the veins of the arm and shoulder, leaving no suitable route for a lead

• An infection that has developed in a pacemaker fitted earlier

• The need to protect the arm veins in people on dialysis

• Situations where making a pocket under the skin would be risky, such as skin problems or a very thin build

• Patients at high risk of bleeding

• People with a suitable rhythm disorder who, because of their work or the way they live, do not want a device at the shoulder

When It Is Not Suitable

• Conduction problems where the atrium and the ventricle need pacing together

• Situations calling for CRT or an ICD

• Anatomies where the groin veins are unsuitable

• Structural problems on the right side of the heart that would prevent the device being seated

Whether it suits you is decided by weighing your rhythm recordings and the structure of your heart together.

How Is a Leadless Pacemaker Fitted?

Beforehand

Bring a full list of the medicines you take; your doctor decides how blood thinners are managed around the procedure. A general assessment is made, including a dental check, to make sure there is no source of infection. You will be told how long to fast.

During the Procedure

It is done under local anaesthetic with light sedation, through the vein in the groin. The capsule is advanced to the right ventricle in a special delivery system.

Before it is fixed, the device is positioned temporarily and measurements are taken: is the impulse capturing the heart adequately, and are the signals strong enough? If the measurements are not right, the device can be moved to a different point in the same session. Once a suitable position is found, the capsule is released.

Afterwards

Pressure is applied at the access site in the groin and it is watched for a period. Your rhythm is monitored and the settings of the device are checked. Discharge is planned after a short period of observation.

Because there is no pocket in the chest, no restriction is placed on your arm movements. A return to heavy activity is planned in stages.

What Happens When the Battery Runs Out?

This is what patients most want to know and are told least about.

How long the device lasts depends on how heavily it is used and on its settings; it is checked regularly at your reviews. The battery does not run out all at once — the decline is seen in advance and the planning follows from that.

When its life is over the device is generally not removed. It is switched off and left inside the heart; if pacing is still needed, a new one is added. The right ventricle has room enough for that. In the early period, retrieving the device is also possible if necessary.

This is something to discuss before the procedure; work out your long-term plan together with your doctor.

What a Pacemaker Does and Does Not Solve

Setting the expectation correctly matters.

What it solves: a pacemaker stops the heart beating more slowly than it should. The aim is to prevent symptoms such as fainting, dizziness and the weakness that comes with a slow pulse. The pulse does not fall below a set limit.

What it does not:

• A pacemaker does not treat blocked arteries. If you have coronary artery disease, its own treatment carries on.

• It does not stop fast rhythm disorders. In conditions such as atrial fibrillation, palpitations can continue and need their own treatment.

• It does not remove the need for a blood thinner. If you are at risk of stroke, that treatment continues.

• It does not treat heart failure. A different kind of device, CRT, is considered for that.

In short, a pacemaker makes up for something that is missing; it does not take the place of treating the underlying heart disease.

What Are the Possible Risks?

• Bleeding, bruising or injury to the vessel at the access site in the groin. Because the delivery system used is thick, this area is watched carefully.

• Injury to the wall of the heart and fluid collecting in the sac around it; rare, and drained if needed.

• The device coming away from its position; rarely seen.

• Infection

• Temporary changes in rhythm during the procedure

• Measurements changing over time and needing the settings adjusted

The risks are weighed against the benefit expected from the procedure and discussed in detail for your own situation at the consultation beforehand.

Living with a Pacemaker

• Reviews: the battery level and the measurements are checked at set intervals. These reviews should not be missed.

• MRI: devices today are made to be MRI-compatible. Always say that you have a pacemaker before a scan; it is done under particular conditions.

• Mobile phones: you can use one. It is enough not to hold it very close to where the device sits.

• Security gates: when going through gates at airports and shopping centres, tell the staff you have a pacemaker and ask to be checked by hand.

• Household appliances: kitchen and household devices cause no problem. If you work in an industrial setting with strong magnetic fields, ask your doctor.

• Your device card: carry the device identification card you are given.

If you notice fainting, sudden weakness, palpitations or swelling at the access site, see your doctor without waiting.

Leadless Pacemakers in Antalya

Prof. Dr. Umuttan Doğan is a cardiologist who trained in electrophysiology at the Gülhane Military Medical Academy in 2012; pacemaker work is one of the areas he works in. The procedures are carried out in the catheter laboratory at Antalya American Hospital.

If a pacemaker has been suggested to you because of fainting, dizziness or a slow pulse, you can be seen at the clinic in Konyaaltı with your rhythm recordings and test results. For the other device treatments see the pacemakers page. You will find his background and contact details on their own pages.

Frequently Asked Questions

Can anyone have a leadless pacemaker?

No. The leadless pacemakers in common use are single-chamber and pace only the right ventricle. They are not suitable where the atrium and ventricle need pacing together, nor for patients who need CRT or an ICD. The decision follows the type of rhythm disorder you have.

Will it be taken out when the battery runs out?

Generally not. The device is switched off and left inside the heart; if pacing is still needed, a new one is added. Retrieving it is also possible in the early period if necessary. The battery does not run out all at once — the decline is seen in advance at your reviews.

Can I use my arm after the procedure?

Yes. Because no pocket is made in the chest and there is no lead, your arm movements are not restricted. A short rest is advised for the access site in the groin, and a return to heavy activity is planned in stages.

Can I have an MRI? Are phones and security gates a problem?

Devices today are made to be MRI-compatible; always say that you have a pacemaker before a scan. You can use a mobile phone, but do not hold it very close to the device. At security gates, tell the staff and ask to be checked by hand.

What is the basic difference from a conventional pacemaker?

With a conventional pacemaker a pocket is made under the skin of the chest and electrode leads run to the heart. A leadless pacemaker has neither pocket nor lead; the capsule goes in through the vein in the groin and is placed directly inside the heart. Against that, a conventional pacemaker can pace more than one chamber, which a leadless one generally cannot.

The information on this page is for general guidance and does not replace a consultation. Decisions about diagnosis and treatment are made by your doctor after assessing your own situation.