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- Publisher Website: 10.1056/NEJMoa2300080
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Article: A Dual-Chamber Leadless Pacemaker
Title | A Dual-Chamber Leadless Pacemaker |
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Authors | |
Keywords | Arrhythmias/Pacemakers/Defibrillators Cardiology Cardiology General |
Issue Date | 20-May-2023 |
Publisher | Massachusetts Medical Society |
Citation | New England Journal of Medicine, 2023, v. 388, n. 25, p. 2360-2370 How to Cite? |
Abstract | BackgroundSingle-chamber ventricular leadless pacemakers do not support atrial pacing or consistent atrioventricular synchrony. A dual-chamber leadless pacemaker system consisting of two devices implanted percutaneously, one in the right atrium and one in the right ventricle, would make leadless pacemaker therapy a treatment option for a wider range of indications.MethodsWe conducted a prospective, multicenter, single-group study to evaluate the safety and performance of a dual-chamber leadless pacemaker system. Patients with a conventional indication for dual-chamber pacing were eligible for participation. The primary safety end point was freedom from complications (i.e., device- or procedure-related serious adverse events) at 90 days. The first primary performance end point was a combination of adequate atrial capture threshold and sensing amplitude at 3 months. The second primary performance end point was at least 70% atrioventricular synchrony at 3 months while the patient was sitting.ResultsAmong the 300 patients enrolled, 190 (63.3%) had sinus-node dysfunction and 100 (33.3%) had atrioventricular block as the primary pacing indication. The implantation procedure was successful (i.e., two functioning leadless pacemakers were implanted and had established implant-to-implant communication) in 295 patients (98.3%). A total of 35 device- or procedure-related serious adverse events occurred in 29 patients. The primary safety end point was met in 271 patients (90.3%; 95% confidence interval [CI], 87.0 to 93.7), which exceeded the performance goal of 78% (P<0.001). The first primary performance end point was met in 90.2% of the patients (95% CI, 86.8 to 93.6), which exceeded the performance goal of 82.5% (P<0.001). The mean (+/- SD) atrial capture threshold was 0.82 +/- 0.70 V, and the mean P-wave amplitude was 3.58 +/- 1.88 mV. Of the 21 patients (7%) with a P-wave amplitude of less than 1.0 mV, none required device revision for inadequate sensing. At least 70% atrioventricular synchrony was achieved in 97.3% of the patients (95% CI, 95.4 to 99.3), which exceeded the performance goal of 83% (P<0.001).ConclusionsThe dual-chamber leadless pacemaker system met the primary safety end point and provided atrial pacing and reliable atrioventricular synchrony for 3 months after implantation. (Funded by Abbott Medical; Aveir DR i2i ClinicalTrials.gov number, .) |
Persistent Identifier | http://hdl.handle.net/10722/338216 |
ISSN | 2023 Impact Factor: 96.2 2023 SCImago Journal Rankings: 20.544 |
ISI Accession Number ID |
DC Field | Value | Language |
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dc.contributor.author | Knops, RE | - |
dc.contributor.author | Reddy, VY | - |
dc.contributor.author | Ip, JE | - |
dc.contributor.author | Doshi, R | - |
dc.contributor.author | Exner, DV | - |
dc.contributor.author | Defaye, P | - |
dc.contributor.author | Canby, R | - |
dc.contributor.author | Bongiorni, MG | - |
dc.contributor.author | Shoda, M | - |
dc.contributor.author | Hindricks, G | - |
dc.contributor.author | Neuzil, P | - |
dc.contributor.author | Rashtian, M | - |
dc.contributor.author | Breeman, KTN | - |
dc.contributor.author | Nevo, JR | - |
dc.contributor.author | Ganz, L | - |
dc.contributor.author | Hubbard, C | - |
dc.contributor.author | Cantillon, DJ | - |
dc.contributor.author | Tse, Hung Fat | - |
dc.contributor.author | Aveir DR i2i Study Investigators | - |
dc.date.accessioned | 2024-03-11T10:27:08Z | - |
dc.date.available | 2024-03-11T10:27:08Z | - |
dc.date.issued | 2023-05-20 | - |
dc.identifier.citation | New England Journal of Medicine, 2023, v. 388, n. 25, p. 2360-2370 | - |
dc.identifier.issn | 0028-4793 | - |
dc.identifier.uri | http://hdl.handle.net/10722/338216 | - |
dc.description.abstract | <p>BackgroundSingle-chamber ventricular leadless pacemakers do not support atrial pacing or consistent atrioventricular synchrony. A dual-chamber leadless pacemaker system consisting of two devices implanted percutaneously, one in the right atrium and one in the right ventricle, would make leadless pacemaker therapy a treatment option for a wider range of indications.MethodsWe conducted a prospective, multicenter, single-group study to evaluate the safety and performance of a dual-chamber leadless pacemaker system. Patients with a conventional indication for dual-chamber pacing were eligible for participation. The primary safety end point was freedom from complications (i.e., device- or procedure-related serious adverse events) at 90 days. The first primary performance end point was a combination of adequate atrial capture threshold and sensing amplitude at 3 months. The second primary performance end point was at least 70% atrioventricular synchrony at 3 months while the patient was sitting.ResultsAmong the 300 patients enrolled, 190 (63.3%) had sinus-node dysfunction and 100 (33.3%) had atrioventricular block as the primary pacing indication. The implantation procedure was successful (i.e., two functioning leadless pacemakers were implanted and had established implant-to-implant communication) in 295 patients (98.3%). A total of 35 device- or procedure-related serious adverse events occurred in 29 patients. The primary safety end point was met in 271 patients (90.3%; 95% confidence interval [CI], 87.0 to 93.7), which exceeded the performance goal of 78% (P<0.001). The first primary performance end point was met in 90.2% of the patients (95% CI, 86.8 to 93.6), which exceeded the performance goal of 82.5% (P<0.001). The mean (+/- SD) atrial capture threshold was 0.82 +/- 0.70 V, and the mean P-wave amplitude was 3.58 +/- 1.88 mV. Of the 21 patients (7%) with a P-wave amplitude of less than 1.0 mV, none required device revision for inadequate sensing. At least 70% atrioventricular synchrony was achieved in 97.3% of the patients (95% CI, 95.4 to 99.3), which exceeded the performance goal of 83% (P<0.001).ConclusionsThe dual-chamber leadless pacemaker system met the primary safety end point and provided atrial pacing and reliable atrioventricular synchrony for 3 months after implantation. (Funded by Abbott Medical; Aveir DR i2i ClinicalTrials.gov number, .)<br></p> | - |
dc.language | eng | - |
dc.publisher | Massachusetts Medical Society | - |
dc.relation.ispartof | New England Journal of Medicine | - |
dc.rights | This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License. | - |
dc.subject | Arrhythmias/Pacemakers/Defibrillators | - |
dc.subject | Cardiology | - |
dc.subject | Cardiology General | - |
dc.title | A Dual-Chamber Leadless Pacemaker | - |
dc.type | Article | - |
dc.identifier.doi | 10.1056/NEJMoa2300080 | - |
dc.identifier.scopus | eid_2-s2.0-85163919700 | - |
dc.identifier.volume | 388 | - |
dc.identifier.issue | 25 | - |
dc.identifier.spage | 2360 | - |
dc.identifier.epage | 2370 | - |
dc.identifier.eissn | 1533-4406 | - |
dc.identifier.isi | WOS:000992862900001 | - |
dc.identifier.issnl | 0028-4793 | - |