Dual-chamber leadless pacemaker implanted successfully, meets 3-month performance goals
Key takeaways:
- A dual-chamber leadless pacemaker met 3-month safety and efficacy performance goals.
- The device avoids complications of traditional pacemakers and can be used more broadly than its single-chamber counterpart.
A dual-chamber leadless pacemaker was successfully implanted in most patients and met its 3-month safety and efficacy performance goals, according to the results of the Aveir DR i2i investigational device exemption trial.
Single-chamber leadless pacemakers avoid the lead-related complications of transvenous pacemakers, but they do not support atrial pacing or atrioventricular synchrony, so the dual-chamber leadless pacemaker (Aveir DR, Abbott) was designed to enable both of those indications, Daniel J. Cantillon, MD, FACC, FHRS, senior vice president of global cardiovascular solutions at Masimo, who was associate section head of cardiac electrophysiology and pacing at Cleveland Clinic when the study was conducted, said during a press conference at Heart Rhythm 2023.
“The Aveir DR is the first-of-its-kind dual-chamber leadless pacemaker with bidirectional communication between two independently implanted devices, one in the right atrium and one in the right ventricle,” Cantillon told Healio. “This communication between the two devices allows the capability for full dual-chamber pacing to support the indications of heart block and sinus node dysfunction.”
The device is not yet approved for commercial use in the United States.
“Complications from traditional pacemakers are quite common,” Cantillon told Healio. “They affect up to one in six patients by 3 years, and they overwhelmingly involve the transvenous leads and the incisional access for surgical pockets. Leadless cardiac pacemakers have neither.”
The study, which was simultaneously published in The New England Journal of Medicine, included 300 patients, of whom 63.3% were indicated for dual-chamber pacing due to sinus node dysfunction and 33.3% were indicated due to atrioventricular block. The primary safety endpoint was freedom from device- or procedure-related serious adverse events at 90 days. The first primary efficacy endpoint was adequate atrial capture threshold and sensing amplitude at 3 months. The second primary efficacy endpoint was at least 70% atrioventricular synchrony at 3 months while the patient was seated.
Implantation was successful, meaning both leadless pacemakers were functioning and communicating with each other, in 98.3% of patients, according to the researchers.
The primary safety endpoint was met in 90.3% of patients (95% CI, 87-93.7), which exceeded the performance goal of 78% (P < .001), Cantillon said during the press conference.
The mean atrial capture threshold was 0.82 V, the mean P wave amplitude was 3.58 mV and the first primary efficacy endpoint was met in 90.2% of patients (95% CI, 86.8-93.6), exceeding the performance goal of 82.5% (P < .001), the researchers found.
There were 21 patients who had P wave amplitude less than 1 mV, but none needed device revision due to inadequate sensing, Cantillon and colleagues found.
The second primary efficacy endpoint was met in 97.3% of patients, exceeding the performance goal of 83% (P < .001), according to the researchers.
“We exceeded all the safety and effectiveness endpoints that were established in advance with the regulatory authorities,” Cantillon told Healio. “The limitation of existing leadless pacemaker technology on the market is that it only accounts for approximately 10% to 20% of all pacing needs. The dual-chamber leadless system accounts for the remaining 80%.”
The device also appeared to improve quality of life in ways that cannot always be captured in quantitative studies, Cantillon told Healio.
“One patient enrolled in this trial had suffered from very severe venous occlusive disease despite repetitive interventions of removing the transvenous wires with laser tools and other techniques to restore blood flow in the upper half of his body,” he said. “After he had all the leads removed and was implanted with the dual-chamber leadless pacemaker system, he came back at the 3-month follow-up and he was in tears, because for the first time in a decade, he had been able to bend over and tie his shoes without being completely breathless. That is the quality of life impact from getting rid of the traditional transvenous system and leveraging the technology that was available. This is not an uncommon story from the physicians involved in the trial. This is a unique subset of patients that stands to benefit very strongly from this technology.”
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I think this is an important study with significant implications for our pacing field. The study provides evidence that dual-chamber pacing can be achieved with leadless technology, and it can be done with two separate devices with a very high degree of AV synchrony. The complication rate was certainly in line with general rates of complications following pacemaker implantation. The 1.7% dislodgement rate is something that we will need to keep an eye on, as embolization of devices is always a significant concern.
The bottom line is that dual-chamber pacing can be done with a very high success rate and excellent results. Obviously, more data as the technology moves into clinical practice will be critical. We will also need to understand which patients are best served by leadless technology and which patients will be better served with traditional transvenous devices. I suspect may of those questions will ultimately require long-term data.
The device is not approved yet, so it is too early to say what the implications for clinical practice are, but it will dramatically alter options, as this will be the first leadless device that can deliver atrial pacing.
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Cantillon DJ, et al. Late Breaking Clinical Trials and Science – Innovations. Presented at: Heart Rhythm 2023; May 19-21, 2023; New Orleans (hybrid meeting).
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