A brand new leadless pacemaker (LP) exhibits promise in safely delivering efficient proper ventricular pacing, and offering an alternative choice to present transvenous pacemakers, new analysis suggests.
Within the LEADLESS II section 2 IDE research, researchers investigated the Aveir LP (Abbott) in 200 sufferers requiring ventricular demand pacing and located an implant success fee of 98%, with most sufferers not requiring repositioning. Furthermore, the first security endpoint, the absence of issues, was met in 96% of sufferers.
“The brand new Aveir pacing system holds the potential to assist us advance remedy for sufferers who want a pacemaker, however the place physicians are involved [is with] extra invasive surgical procedure, or in circumstances the place we consider a affected person’s remedy wants could change sooner or later and the place retrievability will probably be a important system characteristic,” Vivek Y. Reddy, MD, professor of medication and director of cardiac arrhythmia providers, Mount Sinai Hospital, New York Metropolis, stated in a press launch.
“Moreover, this system will — within the not-too-distant-future — have the potential to be upgraded to a dual-chamber system, which we’re trialing in 2022 and stay up for sharing these findings,” Reddy instructed theheart.org | Medscape Cardiology.
The findings have been introduced on the annual Scientific Classes of the Asia Pacific Coronary heart Rhythm Society and concurrently revealed as a analysis letter November 11 within the Journal of the American School of Cardiology: Scientific Electrophysiology.
“Prior research present that as much as 1 in 6 sufferers with conventional transvenous pacemakers could have a critical complication by 3 years,” senior creator Daniel Cantillon, MD, affiliate part head, Cardiac Electrophysiology and Pacing, Cleveland Clinic, Cleveland, Ohio, instructed theheart.org | Medscape Cardiology.
The “overwhelming majority” of those are “associated to the incisional entry created for the pacemaker pocket, similar to bleeding or an infection or leads which can be threaded into the center,” he famous.
LPs scale back issues “by not requiring incisional entry or wires, however somewhat are instantly positioned into the center,” Cantillon stated.
Reddy famous that globally, roughly 10% to fifteen% of sufferers require solely single-chamber pacing of the ventricle and that leadless pacemakers “presently tackle that inhabitants,” which he known as “a smaller share, however a vital subset.”
The primary LP, the Nanostim by St Jude Medical, was launched in 2013 however was faraway from the market due to untimely battery depletion, the authors write.
One other leadless system, the Micra Transcatheter Pacing System by Medtronic, was accredited within the US in 2016, though with a mandated postapproval research, and remains to be the one leadless pacemaker accredited by the FDA.
The present redesigned Aveir LP has “key design enhancements,” the authors word, together with the usage of commonplace transvenous pacemaker battery chemistry, modified docking button, enabling retrievability; a modified supply system with an ergonomic design; and a brand new application-specific built-in circuit (ASIC) chip designed to offer an expandable platform to later help a dual-chamber pacing system as soon as it is accredited.
This present section 2 single-arm trial was developed to enhance the protection and efficiency of the unique product, the researchers word.
The LEADLESS II trial was performed throughout 43 facilities within the US, Canada, and Europe and enrolled 200 sufferers (imply age at enrollment 75.6 years, 62.5% male), with a major pacemaker indication of atrial fibrillation (AF) with atrioventricular block (52.5%). All sufferers had commonplace VVI pacing indications.
Implant success within the section 2 trial was superior to that of the section 1 trial (98% vs 96.3%, respectively) and there was much less repositioning required within the profitable implants in section 2 vs section 1 (83.2% vs 70.2%, respectively).
Of the 198 contributors that have been evaluable, 96% (95% CI, 92.2% – 98.2%) met the first security endpoint, outlined as “freedom from critical antagonistic system occasions (SADEs, additionally known as issues) by 6 weeks of follow-up.” In reality, the decrease certain exceeded the efficiency aim of 86% (P < .0001).
Probably the most frequent issues have been cardiac tamponade and untimely deployment (three instances every).
Inside the effectiveness endpoint evaluation cohort, that’s, the 196 sufferers who had acquired profitable implants, 95.9% (95% CI, 92.1% – 98.2%) met the effectiveness standards, consisting of a “composite rating of acceptable pacing thresholds (≤ 2.0 V at 0.4ms) and R-wave amplitudes (≥ 5.0 mV or ≥ worth at implant) by 6 weeks of follow-up).” The decrease certain equally exceeded the efficiency aim of 85% (P < .0001).
Eight contributors didn’t meet effectiveness standards: 4 failed the seize threshold standards and 4 failed the R-wave amplitude standards.
Each the protection and the efficacy outcomes represented an enchancment over section 1 outcomes, they write.
The secondary consequence, applicable and proportional rate-response pacing throughout graded train, was additionally met, with a imply slope of the regression line between normalized workload and normalized sensor-indicated fee (17 contributors) of 0.93.
Distinctive points of this LP design embrace a modification to the supply catheter, leading to an “improved implant success fee”, the researchers word, in addition to contact mapping previous to LP fixation, that ends in “low repositioning charges throughout implantation,” in comparison with section 1.
Reddy commented that the Aveir system has a “significantly better battery life,” in comparison with current LPs and can also be “the world’s solely leadless pacemaker particularly designed to be retrieved when the system must be changed or if a affected person’s remedy must be modified, [which] is a important system characteristic.”
Reddy famous that, though the pericardial effusion fee was 1.5%, and “we have to see that that improves, current gadgets additionally demonstrated the identical effusion fee” that improved and decreased to “a lot lower than 1%” with elevated operator expertise. “I think about the identical will occur right here,” he stated.
Commenting on the research for theheart.org | Medscape Cardiology, Charles Love, MD, director of cardiac arrhythmia providers and professor of medication, Johns Hopkins College, Baltimore, Maryland, stated that the presently accredited LP, Medtronic’s Micra, has been available on the market for a number of years and has been “rather well acquired, and fills an essential area of interest.”
It represents an enchancment over gadgets that depend upon leads as a result of “wires are usually the weak hyperlink within the system as a result of they dislodge, poke by the center, and may develop into contaminated,” he stated.
Love, who was not concerned with the present research, stated that the brand new system, as soon as accredited, “will do the identical factor and can give us a second choice for gadgets of this kind.”
In response to Love, the primary drawback of LPs is that they tempo just one chamber of the center, however a bonus of this system beneath investigation is that it’s “forward-compatible with a second leadless system to be positioned within the atrium, so we will tempo each chambers of the center and preserve them working collectively on the identical time, which will probably be an enormous enchancment over the present era of leadless gadgets we’re inserting proper now.”
Cantillon stated that the system platform “paves the best way for multichamber leadless cardiac pacing,” noting that presently, LPs solely meet the wants of 10% of sufferers requiring pacing help. “In an effort to serve the remaining 90%, we have to have a leadless pacemaker for each the higher and decrease chambers of the center that may talk instantly.”
On November 17, the FDA issued a warning on the chance of “main issues associated to cardiac perforation throughout implantation” of leadless pacing techniques, referring to the Medtronic Micra leadless system.
Cantillon famous that the Micra system has a “totally different fixation mechanism” to the cardiac tissue than the Aveir system beneath investigation. Specifically, the Aveir system makes use of a helix somewhat than tines (small anchors) and doesn’t require the appliance of ahead strain to have interaction into the center.
However, Love added, “as famous within the [FDA] notification concerning the Micra pacemaker, cardiac perforation is actually a risk with any pacemaker” and “perforation for Micra could be related to pericardial tamponade,” though he known as this “unusual.”
For that motive, “one should be conscious that it could occur and be able to take care of it, simply as one should be able to take care of it in another system,” Love stated.
He instructed that the chance of perforation “could also be increased once we begin inserting these [leadless devices] into the atrium, for the reason that atrium is far more skinny than the ventricle, and there could also be the next danger of perforation there.”
He added, “I feel the FDA bulletin clearly states what all physicians must do, and that’s to stability the dangers and the advantages of every process relative to the wants of every particular person affected person.”
Due to excessive failure charges related to commonplace pacemaker wires, there “is a variety of momentum about leadless gadgets, stated Love, and he doesn’t assume “that we are going to see a lower within the enthusiasm for utilizing these gadgets, even with the latest notification by the FDA.”
Certainly, the potential for leadless pacemakers continues to increase. Earlier this wee, a novel leadless pacemaker defibrillator system manufactured by Boston Scientific was implanted in two sufferers on the Cleveland Clinic. The system brings collectively the know-how of a leadless pacemaker with a subcutaneous implantable cardioverter defibrillator, managing to ship remedy for each low and elevated coronary heart charges.
The implantation of this system kicks off the multicenter MODULAR ATP trial that can consider the protection, efficiency, and effectiveness of the modular cardiac rhythm administration system.
Cantillon, a principal investigator within the trial, stated in a press launch, “Mixed use of each forms of gadgets in a leadless method may gain advantage a a lot bigger affected person inhabitants…It is our hope that the mix of a tiny, leadless pacemaker implanted instantly into the center with the subcutaneous-ICD within the mushy tissue will enable the vast majority of deadly arrhythmias to be painlessly terminated with out long-term dangers.”
The LEADLESS II research was funded by Abbott. Reddy is an unpaid marketing consultant for Abbott; Unrelated to this manuscript, he has served as a marketing consultant for and has fairness in Ablacon, Acutus Medical, Affera, Apama Medical, Aquaheart, Atacor, Autonomix, Backbeat, BioSig, Circa Scientific, Coria Medical, Dinova-Hangzhou Nuomao Medtech Co, Ltd, East Finish Medical, EPD, Epix Therapeutics, EpiEP, Eximo, Fire1, Javelin, Kardium, Keystone Coronary heart, LuxCath, Medlumics, Middlepeak, Nuvera, Sirona Medical, and Valcare; has served as a marketing consultant for Axon, Biotronik, Cardiofocus, Cardionomic, CardioNXT/AFTx, EBR, Impulse Dynamics, Medtronic, Philips, Pulse Biosciences, Stimda, and Thermedical unrelated to this work; and has fairness in Guide Surgical Sciences, Newpace, Surecor, and Vizaramed.
Cantillon is a marketing consultant for Abbott and Boston Scientific. The opposite authors’ disclosures are listed on the unique paper. Love is a marketing consultant to Medtronic.
JACC Clin Electrophysiol. Printed on-line November 11, 2021. Summary