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One-Year Safety and Performance of a Dual-Chamber Leadless Pacemaker
RE. Knops, JE. Ip, R. Doshi, DV. Exner, P. Defaye, R. Canby, MG. Bongiorni, M. Shoda, G. Hindricks, P. Neužil, M. Rashtian, KTN. Breeman, JR. Nevo, L. Ganz, C. Hubbard, A. Bulusu, VY. Reddy
Jazyk angličtina Země Spojené státy americké
Typ dokumentu časopisecké články, multicentrická studie
- MeSH
- atrioventrikulární blokáda * terapie patofyziologie MeSH
- bradykardie * terapie patofyziologie diagnóza MeSH
- časové faktory MeSH
- design vybavení MeSH
- kardiostimulace umělá * škodlivé účinky metody MeSH
- kardiostimulátor * MeSH
- lidé středního věku MeSH
- lidé MeSH
- prospektivní studie MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- srdeční frekvence * MeSH
- syndrom chorého sinu * terapie patofyziologie diagnóza MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
BACKGROUND: A dual-chamber leadless pacemaker can provide bradycardia therapy to most patients with pacemaker indications without the complications associated with a lead or pulse generator. We sought to confirm whether previously reported 3-month safety and performance outcomes were sustained through 12 months by determining whether 12-month complication-free and performance success rates exceeded their prespecified performance goals. METHODS: Patients were enrolled in the prospective, single-group Aveir DR i2i Study if they had a standard indication for dual-chamber pacing. Enrolled patients were implanted with an Aveir DR dual-chamber leadless pacemaker system, which comprised 2 communicating leadless pacemakers (1 in the right atrium and 1 in the right ventricle). The primary safety outcome evaluated whether freedom from serious device- or procedure-related events through 365 days exceeded the predetermined performance goal of 76.5%. The primary performance outcome determined whether the composite of atrial capture threshold (≤3.0 V at 0.4 ms) and sensing amplitude (P-wave ≥1.0 mV) at the 12-month visit exceeded the predetermined performance goal of 80.0%. RESULTS: Sites attempted implantation in 300 subjects, where 63.3% had sinus-node dysfunction and 33.3% had atrioventricular block as their primary pacing indication. The primary safety end point was achieved, with a Kaplan-Meier 12-month complication-free rate of 88.6% (95% CI, 84.5-91.8; P<0.001). The primary performance end point was achieved in 92.8% of patients (95% CI, 89.7-95.8; P<0.001). CONCLUSIONS: Both primary safety and performance end points were met after 1 year, demonstrating consistency with previously reported 3-month outcomes of a dual-chamber leadless pacemaker. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05252702.
CHRU Albert Michallon Grenoble France
Foothills Medical Centre Calgary Alberta Canada
German Heart Center of the Charite Berlin Germany
HonorHealth Cardiac Arrhythmia Group Scottsdale AZ
Huntington Memorial Hospital Pasadena CA
Mount Sinai Fuster Heart Hospital Icahn School of Medicine at Mount Sinai New York NY
Na Homolce Hospital Prague Czech Republic
San Rossore Private Hospital and Medical Center Pisa Italy
Texas Cardiac Arrhythmia Institute Austin TX
Citace poskytuje Crossref.org
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