Leadless pacemakers, subcutaneous defibrillators successfully implanted in pediatric patients

Two new devices being used in adults with heart rhythm disorders — atrial and dual chamber leadless pacemakers and extravascular defibrillators — were successfully implanted in pediatric patients for the first time at Children’s National. These devices represent the latest technology in pacing and defibrillating the heart to maintain its rhythm. Though they are smaller in size, have fewer complications and longer battery life than most of the devices currently available for young patients, they have not been available for use in these younger patients until recently.

“For the first time, we’re bringing these devices that are smaller, smarter, less painful and more flexible to children and teenagers who can really benefit from them,” says Elizabeth Sherwin, MD, a pediatric cardiologist and electrophysiologist at Children’s National who led the teams completing these minimally invasive procedures.

The patient benefit

Offering implantation of these devices gives more children and adults with congenital heart disease access to the latest technologies in implantable heart rhythm devices, which may offer unique benefits for these groups.

Abbott AVEIR dual chamber leadless pacemaker is the newest FDA approved leadless pacemaker. It uses electricity to maintain heart rhythm and can be used to pace both the top and bottom chambers of the heart, which is particularly important for pediatric and adult congenital patients. These devices also:

• Are designed to be removed and replaced after battery runs down, which is ideal for children and young adults who will have multiple replacements over a lifetime.
• Long battery life, so fewer replacements may be necessary.
• Can be placed minimally invasively

Dr. Sherwin says that the minimally invasive procedure and the lack of leads on these devices are particularly key for younger people because these factors remove or reduce the risk of complications commonly experienced with pacemakers in children. There is a reduced risk of bleeding, infection, lead movement or fracture, and long-term problems with the veins.  Even better, because they are placed directly in the heart, there are no scars on the chest or visible signs of a pacemaker present.

Medtronic Aurora EV-ICD is an extravascular implantable cardioverter-defibrillator (ICD), which is implanted under the skin (subcutaneous) with a generator on the left chest wall and a lead that goes under the breastbone (sternum). The design includes:

• A smaller generator.
• No need to go through chest muscle, leading to less painful implantation and more comfort long term.
• Emergency heart pacing through the substernal lead – both to try to terminate a fast arrhythmia to avoid need for a shock, and to treat in case the heartbeat is too slow.
• Longer battery life (projected 11 years).
• Avoids the need to have leads in the blood vessels, with the many potential complications that go along with transvenous leads.

For both of these newer devices, the patient’s size, weight and medical history will help determine if they are a good candidate.

The big picture

The Electrophysiology team is the first and only pediatric and congenital cardiology team trained to implant AVEIR leadless pacemakers  and the Aurora EV-ICD for eligible individuals in the mid-Atlantic region. Dr. Sherwin, Charles Berul, MD, and Tom (Nak) Choi, MD, are trained to provide these procedures for people in Washington, DC, Virginia and Maryland. For both devices, Children’s National is among only a handful of children’s hospitals in the U.S. with the training and expertise to offer access to these technologies.

“This is a game-changer for kids with rhythm disorders and adults with congenital heart disease,” Dr. Sherwin says. “We are really excited to be among the first to offer these options for patients who need them.”