Cardiac electrostimulation: the leadless pacemaker

By Cristiano Antonino On Jun 16, 2023

As technology evolved, the leadless pacemaker was introduced in 2015; a real revolution in cardiac electrostimulation

This pacemaker, without leads, is a very small implant that is implanted in the heart via a minimally invasive procedure that does not require surgery.

A pacemaker is an electronic device that monitors cardiac activity by electrically stimulating the heart if heart activity slows down.

By stimulating the heart, the pacemaker replaces the heart’s electrical system that is ‘defective’

The traditional pacemaker is made from a generator, a little larger than a 2 euro coin, and is implanted with a small surgical procedure in a subcutaneous pocket that is usually placed under the collarbone, either right or left.

It is connected to wires, the leads, which are permanently inserted into the chambers of the heart.

Their function, is to generate and transmit electrical impulses to the heart, transmitting the heart’s cardiac activity to the pacemaker.

Complications can affect up to 10% of patients.

More than 80% of complications are due to the subcutaneous pocket and the leads; the subcutaneous pocket may lead to haematoma and infection, the leads on the other hand may move, rupture or become infected.

Infection of the leads can lead to a serious infection of the heart, endocarditis, which can lead to death.

To treat the infection, the patient must undergo pacemaker explantation and lead extraction; the extraction procedure is a complex and risky operation.

Most of the complications associated with implanting a pacemaker are related to the subcutaneous pocket and the leads.

Getting rid of these two elements will eliminate pacemaker-related complications.

But, returning to the wireless pacemaker, it is an extremely small pacemaker, weighing just 2 grams and less than 3 cm long, compared to the 30 grams of the conventional pacemaker.

Its implantation is performed under local anaesthesia, is inserted via a femoral vein, and does not require any surgical cutting.

Via a small tube, the pacemaker is pushed into the heart where it anchors itself to the heart wall in order to stimulate the heart.

The implantation of such a device takes between 45 and 50 minutes, the battery life is about 10 years.

It does not require any subcutaneous pocket and has no leads that have to be inserted into the heart, so complications due to pocket and leads are also avoided.

This small, leadless pacemaker has been implanted in over 50,000 patients around the globe

It has been declared safer than the traditional pacemaker due to the reduced number of complications compared to the traditional defibrillator.

The leadless pacemaker, as it has no leads, does not require any caution on the part of the patient

After implantation of the conventional pacemaker, the patient must avoid exertion and sudden movements in order to prevent the leads from moving and risk the subcutaneous pocket wound from opening.

With the wireless pacemaker, the patient can return to normal activity as early as 2 days after surgery.

There will also be no scarring on the chest, and in this way, aesthetic and psychological impacts will also be avoided.

However, the wireless pacemaker can currently only be implanted in one chamber of the heart, namely in the right ventricle.

Therefore, not everyone can benefit from this innovative device, but only those who need the right ventricle to be stimulated.

A pacemaker is being studied that is capable of stimulating not only the right ventricle but also the rest of the heart, i.e. the left ventricle and atria.

The traditional pacemaker, over time, sees the veins and the heart encase the leads, which will be blocked inside them by real scars.

Removing them therefore becomes increasingly risky, and a probable operation to remove them would be extremely complex.

Risks associated with the implantation of a leadless pacemaker

However, the implantation of a wireless pacemaker also has risks; at the level of the femoral puncture, trauma to the vein with even major haematomas can occur, up to and including rupture of the vein.

At the level of the heart, infections may be triggered and it may happen that the device breaks free from its anchorage, floating inside the ventricle or ending up in the pulmonary artery.

During implantation, arrhythmias due to mechanical stimulation could occur.

These are possible but more than rare occurrences that only time will be able to give us sufficient numbers to draw up reliable statistics.

To date, the system is completely safe and reliable and the risks are far lower than those of a conventional pacemaker.

Therefore, if a traditional pacemaker wearer wanted to replace his pacemaker with a wireless one, he would not be able to do so.

There are pathologies that degenerate, in most cases related to ageing; these pathologies affect the heart, which is no longer able to generate the electrical impulse correctly or conduct it correctly to all parts of the heart.

This leads the heart to slow down or, in more serious cases, to stop with very serious consequences.

Therefore, the future of cardiac electrostimulation sees the wireless pacemaker as its best representative and aid in this field.

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