A Dual-Chamber Leadless Pacemaker.
Journal
The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562
Informations de publication
Date de publication:
22 Jun 2023
22 Jun 2023
Historique:
medline:
23
6
2023
pubmed:
22
5
2023
entrez:
22
5
2023
Statut:
ppublish
Résumé
Single-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. We 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. Among 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). The 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, NCT05252702.).
Sections du résumé
BACKGROUND
BACKGROUND
Single-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.
METHODS
METHODS
We 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.
RESULTS
RESULTS
Among 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).
CONCLUSIONS
CONCLUSIONS
The 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, NCT05252702.).
Identifiants
pubmed: 37212442
doi: 10.1056/NEJMoa2300080
doi:
Banques de données
ClinicalTrials.gov
['NCT05252702']
Types de publication
Clinical Study
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
2360-2370Investigateurs
Usman Siddiqui
(U)
Monica Lo
(M)
Devi Nair
(D)
Kevin Rist
(K)
Mohammad E Mortada
(ME)
Gery Tomassoni
(G)
Venkata Sagi
(V)
Robert Percell
(R)
Joseph Levine
(J)
D Kirby
(D)
Jamie Kim
(J)
Michael Shehata
(M)
Ramin Davoudi
(R)
Pramod Deshmukh
(P)
Anand Shah
(A)
Eathar Razak
(E)
John Summers
(J)
Rahul Doshi
(R)
Mayer Rashtian
(M)
Mohit Chawla
(M)
Mark Mascarenhas
(M)
Nigel Gupta
(N)
Dhanunjaya Lakkireddy
(D)
Matthew Bernabei
(M)
Paul Friedman
(P)
Ramesh Hariharan
(R)
Srinivas Dukkipati
(S)
Kenneth Plunkitt
(K)
James E Ip
(JE)
Larry Chinitz
(L)
Elaine Wan
(E)
Laurence Epstein
(L)
Jaret Tyler
(J)
Coty Jewell
(C)
Sammy Khatib
(S)
Shephal Doshi
(S)
Kent Nilsson
(K)
Chinmay Patel
(C)
Mark Shen
(M)
Rajesh Banker
(R)
Christian Machado
(C)
Brian Kim
(B)
Darren Jones
(D)
Parikshit Sharma
(P)
Christopher Stanton
(C)
Dilip Mathew
(D)
Sri Sundaram
(S)
Javier Roman-Gonzalez
(J)
John Ip
(J)
Robert Canby
(R)
Daniel J Cantillon
(DJ)
Miguel Valderrabano
(M)
Ulrika Birgersdotter-Green
(U)
Sandeep Jain
(S)
T Jared Bunch
(TJ)
Andrew Zadeh
(A)
Travis Richardson
(T)
Prashant Bhave
(P)
Zayd Eldadah
(Z)
Blandine Mondesert
(B)
Derek Exner
(D)
Frederic Paulin
(F)
Ratika Parkash
(R)
Bernice Tsang
(B)
Reinoud Knops
(R)
Giulio Zucchelli
(G)
Pascal Defaye
(P)
Claudio Tondo
(C)
Gerhard Hindricks
(G)
Jean-Claude Deharo
(JC)
Joaquin Fernandez Concha
(J)
Lluis Mont
(L)
Tim Betts
(T)
Clemens Steinwender
(C)
Johannes Sperzel
(J)
Petr Neuzil
(P)
Tom Wong
(T)
Christophe Garweg
(C)
Chin Pang Chan
(CP)
Hung Fat Tse
(HF)
Kenji Ando
(K)
Hiroshi Tasaka
(H)
Kengo Kusano
(K)
Junichi Yamaguchi
(J)
Lian-Yu Lin
(LY)
Reinoud E Knops
(RE)
Vivek Y Reddy
(VY)
Derek V Exner
(DV)
Maria Grazia Bongiorni
(M)
Morio Shoda
(M)
Joshua M Cooper
(JM)
Stephen Fahrig
(S)
Raul Weiss
(R)
James D Allred
(JD)
Judith Mackall
(J)
Bruce C Stouch
(BC)
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