NEW ORLEANS — A leadless dual-chamber pacemaker with bidirectional wi-fi verbal exchange became in very promising rapid-interval of time results in patients with standard indications for dual-chamber pacing, in step with the Aveir DR i2i Be aware.
The implantation map, consisting of two functioning leadless pacemakers that established implant-to-implant verbal exchange, was a success in 98.3% (n=295 of 300) of trial patients, reported Daniel Cantillon, MD, of Masimo in Irvine, California, on the Coronary heart Rhythm Society (HRS) assembly.
“These results at 3-months note-up personal been very encouraging and obvious,” he said at an HRS press convention. The look findings personal been concurrently printed within the Contemporary England Journal of Medication. Cantillion is an Aveir DR i2i Be aware co-investigator and was on the Cleveland Medical institution when the dual-chamber leadless pacemaker system was developed.
He reported that for basically the most novel look, 190 patients personal been diagnosed with sinus-node dysfunction and 100 patients personal been diagnosed with atrioventricular block as the main pacing indication. The ongoing look will within the spoil encompass as much as 550 patients eligible for dual-chamber pacing.
Cantillion and colleagues reported that the look’s main safety endpoint — freedom from software program- or map-related serious detrimental events (AEs) at 90 days — was met in 90.3% ( 95% CI 87.0-93.7) of patients, and that exceeded the performance purpose of 78% (P<0.001). There personal been 35 of these AEs in 29 look patients.
Also, the first main performance endpoint — a combination of ample atrial capture threshold and sensing amplitude at 3 months — was met in 90.2% of the patients (95% CI 86.8-93.6), which exceeded the performance purpose of 82.5% (P<0.001).
The imply atrial capture threshold was 0.82 V, while the imply P-wave amplitude was 3.58 mV, in step with the researchers, who also reported that amongst 7% with a P-wave amplitude of <1.0 mV, no one wanted software program revision for inadequate sensing.
And the 2d main performance endpoint was as a minimal 70% atrioventricular synchrony at 3 months while the patient was seated, and 97.3% (95% CI 95.4-ninety nine.3) completed this, thereby exceeding the performance purpose of 83% (P<0.001).
“Every leadless pacemaker is 6.5 mm in diameter and affixes to the endocardium thru an active fixation helix,” the researchers outlined. “The ventricular leadless pacemaker measures 38 mm in length and has a purpose place for implantation within the decrease to mid-septal home of the excellent-looking out ventricle.” Fluoroscopy was required for all procedures, while intracardiac echocardiography might maybe maybe maybe well be used as an help for directing implantation.
A bit over 62.7% of the patients personal been male (age 69.2) while around 67% where white. About 61% personal been within the U.S. and about 63% had a main pacemaker indication of sinus-node dysfunction.
The researchers reported 28 complications happened within 2 days after implantation. Complications included atrial fibrillation, serious cardiac misfortune events, and intraprocedural dislodgements of a leadless pacemaker. “Five dislodgements personal been related to inadequate fixation, and in a single case the pacemaker was automatically dislodged by an intracardiac echocardiography catheter. In all cases, the dislodged leadless pacemaker was retrieved efficiently and reimplanted all the way thru the preliminary map,” the researchers said.
Besides they eminent that “no map or software program-related deaths happened. The incidence of acute complications was the same to that seen in analysis of transvenous dual-chamber pacemakers. In our look, serious cardiac misfortune of pericardial effusion happened in 0.7% of the patients, which compares favorably to both the 0.8% incidence of perforation in a most novel meta-prognosis of transvenous pacemaker analysis and the 1.5% incidence of perforation within the preliminary single-chamber leadless pacemaker trials.”
Be aware obstacles included its “single-community nature, which precluded an immediate comparability of [the device’s] safety and performance with these of ragged transvenous pacemakers.” Also, only rapid-interval of time note-up records personal been reported.
“Despite the indisputable truth that this dual-chamber system requires implantation of two gadgets, the low percentage of patients with perforation in our look most definitely stems in section from the assortment of investigators who had immense skills with leadless pacemaker implantation and rigorous pre-look coaching. We seen a larger-than-anticipated incidence of dislodgement all the way thru and after the implantation map: 1.7% for every, as when compared with the 1.1% within the preliminary trial of the ventricular leadless pacemaker, 0.11% in staunch-world skills with ventricular leadless pacemakers, and 1.9% for atrial lead dislocation within 2 months in staunch-world skills with transvenous pacemakers,” the researchers reported.
Cantillion stressed out that “all of these dislodgements personal been efficiently managed percutaneously.”
He pointed out to MedPage Recently that ragged pacemakers personal complications that affect one in six patients after 3 years of note-up, and these are overwhelmingly related to the transvenous leads and to the incisional secure admission to notable for the surgical pocket. Leadless pacemakers personal neither, he said.
HRS press convention moderator Fred Kusumoto, MD, of the Mayo Medical institution in Jacksonville, Florida, suggested MedPage Recently that “the lead is the weakest link in pacemaker technology. There are a spacious desire of times when we have complications with leads. Eliminating leads is a precious system.”
“But whenever we put in any form of software program, it is over the arc of a patient’s lifetime that they strive to give therapy, so the demand is how is that this going to fit into one thing that we have a in point of fact established technology for [that] has been around now for 70 years,” Kusumoto said.
“We make no longer know if this novel software program will provide the optimum technique to tempo the heart. Right here’s exiting technology, and immense proof-of-theory, however it completely is step one in a immense staircase,” he said.
Disclosures
The Aveir DR i2i Be aware was funded by Abbott Medical Devices.
Cantillon and co-authors disclosed relationships with, and/or beef up from, extra than one entities, including Abbott Medical Devices.
Kusumoto disclosed no relationships with industry.
Foremost Supply
Contemporary England Journal of Medication
Supply Reference: Knops R, et al “A dual-chamber leadless pacemaker” N Engl J Med 2023; DOI:n10.1056/NEJMoa2300080.