Scientists at the University of Auckland are planning to recruit patients in New Zealand for a trial to assess a pacemaker designed to reestablish the heart’s naturally irregular beat and reverse heart failure.
Pacemakers today pace the heart metronomically, which creates a steady, even pace. This, however, is different from a healthy individual’s or animal’s heartbeat, which is constantly on the move and modulated by breathing.
The new pacemaker is designed to ensure this by using inhalation and exhalation signals to communicate with the body and pace the heart up when breathing in and down when breathing out. By creating an irregular heartbeat versus a steady, paced one, the solution improves the ability of the heart to pump blood throughout the body by 20% and essential contractile proteins reemerge and realign.
The device was developed with unique analogue pacemaker technology from Ceryx Medical, which is funding the first human clinical trial on its efficiency. It has already been tested on sheep. The human trial will commence in July 2022, according to professor Julian Paton, a lead researcher and director of Manaaki Manawa, the Centre for Heart Research at the University of Auckland.
"We have found a 20% improvement in cardiac output before any medication is used in heart failure. This reflects at least twice what is seen with conventional pacing/optimal medication. Our pacing methodology also reduces sleep apnea and improves blood flow to organs. It resets the baroreceptor reflex, which is an excellent prognostic indicator. And unlike conventional pacing, our variable pacing reverses the damage to the heart cells," he told HCB News.
The loss of an irregular heartbeat is an early sign of cardiovascular disease. Patients can take drugs to feel better, but they do not address or fix the damaged tissues, which are not contracting as efficiently.
The device was successful in a study of rats, and more recently, in a large animal model of heart failure. The human trial will be led by Dr. Martin Stiles, a cardiologist from Waikato Hospital in Hamilton, New Zealand. Patients will be recruited later this year for the trial, which is supported by Ceryx Medical, a startup company that owns the IP on the unique electronics within the bionic pacemaker.
The aim, according to Paton, is to assess the safety and feasibility of short-term variable pacing in patients with temporary external pacing wires fitted following surgery. "We will make analogous measures to those in the sheep, such as cardiac output, ejection fraction, biomarkers, sleep disordered breathing and exercise tolerance."
Earlier this month, Abbott announced that the first dual-chamber, leadless pacemaker was implanted
for the first time in a human patient. Whereas traditional pacemakers are implanted in the chest, leadless ones are placed directly into the heart through a minimally invasive catheter-based procedure that eliminates the need for cardiac leads. This reduces lead-related complications and creates a less restrictive recovery period.
Additionally, the new leadless pacemaker is a double-chamber one, whereas traditional leadless options have been limited to single-chamber devices, due to it being difficult to synchronize two leadless pacemakers. Abbott’s uses i2i technology for beat-by-beat communication between the two, with one in the right ventricle and one in the right atrium. This regulates heart rate synchronously between chambers and allows for dual-chamber leadless pacing.
The prior study at the University of Auckland was funded by the Health Research Council of New Zealand. The findings were published in Basic Research in Cardiology