Cardiac Electrophysiologist at the Cape Town AF Centre located in Mediclinic Panorama, Dr Razeen Gopal, has percutaneously inserted the world’s smallest pacemaker into the heart of a 74 year old female patient.
A day after the operation, Dr Gopal performed three more implantations to complete the first post FDA-approval series of commercial intracardiac pacemaker implants in Africa.
The Medtronic Micra® Transcatheter Pacing System (TPS) is the first FDA approved product with miniaturised pacing technology, and at 6.7 mm in diameter and 25.9 mm in length is only one-tenth the size of an ordinary pacemaker.
“It’s cosmetically invisible and is small enough to be delivered through a catheter via the femoral vein in the groin and implanted directly into the right ventricle of the heart, providing a safe alternative to conventional pacemakers without the complications associated with cardiac wires,” said Dr Gopal.
Comparable to the size of a large vitamin, the small intracardiac pacemaker is attached to the heart with small tines and this allows it to deliver electrical pulses that pace the heart through an electrode at the end of the device.
The pacemaker is inserted into the right ventricle – thus first passing through the right atrium and the tricuspid valve – where it is carefully and specifically placed at the bottom part of the right ventricle, and attached to the thick part of the septum between the two ventricles.
Unlike traditional pacemakers, it doesn’t require leads or a surgical ‘pocket’ under the skin, eliminating potential sources of related complications like infection.
The device responds to patients’ activity levels by automatically adjusting therapy. According to Mediclinic, the diminutive pacemaker is a rate-responsive device with a very sophisticated built-in accelerometer that can distinguish between the heart’s own natural beating rhythm and the movements of the patient.
“It’s the first and only transcatheter system to be approved for both 1.5 and 3 Tesla full-body magnetic resonance imaging (MRI) scans, providing patients with access to the most advanced imaging diagnostic procedures available,” said Dr Gopal.
While the device is designed to be left in the body, the design does incorporate a retrieval feature should this be necessary.
The average battery life of the device is about 10 years, and a second or even a third device can be placed in the right ventricle if necessary in future.
“It’s important for our patients that they can benefit from such technology; the research has shown that the intracardiac pacemaker has very low complication rates and that there was a significant reduction in healthcare utilisation compared to traditional pacemaking systems. We need to offer solutions that are going to positively impact our patients’ lifestyles,” said Mediclinic Panorama Hospital General Manager, Riaan Vorster.
“Mediclinic is always investigating how the needs of our patients can be answered through innovation and we believe that Dr Gopal’s introduction of this technology into our hospital is one of these remarkable situations,” concluded Vorster.