World’s first leadless LBBAP procedures linked to ‘promising’ outcomes
Using a leadless pacemaker to perform leadless left bundle branch area pacing (LBBAP) is both safe and effective, according to new first-in-human data published in Heart Rhythm.[1]
Cardiologists have started turning to leadless pacemakers more and more for cardiac pacing, but those devices have not previously been able to perform LBBAP. This latest analysis focused on the world’s very first leadless LBBAP procedures.
LBBAP was performed on a total of 10 patients with Abbott’s investigational Aveir conduction system pacing (CSP) leadless pacemaker system, part of the same device portfolio that includes the U.S. Food and Drug Administration (FDA)-approved Aveir dual chamber leadless pacemaker system. Abbott previously celebrated the first procedures performed as part of this trial. This full study provides much more context about the early impact of LBBAP with the Aveir CSP technology.
Additional details about the device and procedures
The Aveir CSP leadless pacemaker system has not yet been approved by the FDA. It includes a fixation helix that connects it to the patient’s right ventricular septal wall and an extended pacing/sensing electrode with a distal helix that penetrates their interventricular septum. It communicates bi-directionally with the programmer system using electrical signals conducted between its own electrodes and patch electrodes on the patient’s chest.
The Aveir conduction system pacing (CSP) leadless pacemaker system from Abbott. Illustration courtesy of Reddy et al. and Heart Rhythm.
Baseline cardiac CT and transthoracic echocardiograms were performed prior to each implant. The device was then delivered through the right internal jugular vein to the target implant area of the patient’s right ventricular septum between their tricuspid valve annulus and right ventricular apex.
At the end of the procedure, the device was removed and a traditional leadless pacemaker was implanted using the same access.
Exploring first-in-human data on leadless left bundle branch area pacing
The study included 14 patients with a mean age of 69.4 years old. The most common pacing indications were sinus node dysfunction, second-degree atrioventricular block and vasovagal syncope. The mean baseline QRS duration was 122.3 milliseconds. All patients had mild or moderate tricuspid regurgitation, and 21.4% of patients presented with coronary artery disease.
The Aveir CSP leadless pacemaker was ultimately implanted in 10 patients. Of those four patients who did not receive the device, two did not undergo the procedure due to the results of their baseline imaging exams. The implant process did begin for the other two patients, but the device was never deployed due to issues identifying the right implant position.
Of those 10 patients who received the device, the mean procedure and fluoroscopy times were 48.1 minutes and 15.9 minutes, respectively. The mean pacing threshold, R-wave amplitude and impedance were 1.2 milliseconds, 10.2 mV and 373 ohms, respectively.
In addition, LBBAP capture was seen in 50% of patients of those 10 patients. This included direct capture of the left bundle branch in one patient and left ventricular septal pacing in four patients. Deep septal pacing was seen in another three. Freedom from serious device-related adverse events after one month was 85.7%.
“In this proof-of-principle first-in-human study, the novel CSP leadless pacemaker with shorter body length and extended distal electrode was able to achieve LBBAP capture, while demonstrating acceptable safety and performance,” wrote first author Vivek Y. Reddy, MD, director of cardiac arrhythmia services at Mount Sinai Hospital, and colleagues.
Reddy et al. added that there were certain limitations to their research, including the small number of patients, but “the results of this study are promising enough to support further research.”
Read the full analysis here.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.