AIMS: A dual-chamber leadless pacemaker (LP) system that employs distinct atrial and ventricular LP devices (ALP, VLP) has been introduced to clinical practice. Proprietary, low-energy, implant-to-implant (i2i) communication at each beat enables the devices to maintain synchronous atrioventricular sensing and pacing. We evaluated device longevities and contributing factors, such as i2i communication. METHODS AND RESULTS: Patients meeting dual-chamber pacing indications received the dual-chamber LP system as part of a prospective, multi-centre, international clinical trial (Aveir DR i2i Study, NCT05252702). Programming and diagnostics were interrogated from all de novo, non-revised, dual-chamber programmed devices at 12 months post-implant. This analysis included 302 patients (65% male; age 70 ± 13 years; weight 80 ± 19 kg; intrinsic heart rate 55 ± 7 bpm; 58% sinus node dysfunction, 27% atrioventricular block). At 12 months, devices were programmed to dual-chamber pacing (DDD(R) or DDI(R)) at a median 60 bpm rate, median 1.25 V pulse amplitude in ALP and 1.5 V in VLP, median 0.4 ms pulse width, and median i2i signal setting level 5 out of 7. Median ALP and VLP remaining battery longevities at 12 months were 4.3 and 9.1 years, with median total ALP and VLP longevities of 5.3 and 9.9 years. Base rate, pulse amplitude, pacing percentage, event rate, impedance, and i2i setting level all exhibited significant correlations with ALP and VLP longevities (P < 0.001). Programming i2i setting levels below 7 produced the greatest longevity savings. CONCLUSION: The first dual-chamber LP demonstrated adequate projected battery longevity after 12 months of use. Patient-specific device programming considerations, unique to leadless devices, may extend longevity.

Cardiac Rhythm Management Abbott Sunnyvale CA USA

Department of Cardiac Sciences Foothills Medical Centre Calgary Canada

Department of Cardiology and Electrophysiology Amsterdam UMC Amsterdam The Netherlands

Department of Cardiology and Vascular Medicine CHRU Albert Michallon Grenoble France

Department of Cardiology Heart Center Leipzig GmbH Leipzig Germany

Department of Cardiology Na Homolce Hospital Prague Czech Republic

Department of Cardiology San Rossore Private Hospital and Medical Center Pisa Italy

Department of Cardiology Texas Cardiac Arrhythmia Institute Austin TX USA

Department of Cardiology Tokyo Women's Medical University Tokyo Japan

Department of Cardiology Weill Cornell Medicine New York Presbyterian Hospital New York NY USA

Department of Cardiovascular Medicine Cleveland Clinic Foundation Cleveland OH USA

Department of Clinical Cardiac Electrophysiology HonorHealth Cardiac Arrhythmia Group Scottsdale AZ USA

Helmsley Electrophysiology Center Mount Sinai Fuster Heart Hospital Icahn School of Medicine at Mount Sinai 1190 5th Ave New York NY 10029 USA

doi: 10.1093/europace/euaf073 PubMed

Zobrazit více v PubMed

Reddy  VY, Exner  DV, Doshi  R, Tomassoni  G, Bunch  TJ, Estes  NAM, et al.  Primary results on safety and efficacy from the LEADLESS II-Phase 2 worldwide clinical trial. JACC Clin Electrophysiol  2022;8:115–7. PubMed

Cantillon  DJ, Dukkipati  SR, Ip  JH, Exner  DV, Niazi  IK, Banker  RS, et al.  Comparative study of acute and mid-term complications with leadless and transvenous cardiac pacemakers. Heart Rhythm  2018;15:1023–30. PubMed

Sattar  Y, Ullah  W, Roomi  S, Rauf  H, Mukhtar  M, Ahmad  A, et al.  Complications of leadless vs conventional (lead) artificial pacemakers—a retrospective review. J Community Hosp Intern Med Perspect  2020;10:328–33. PubMed PMC

Boveda  S, Higuera  L, Longacre  C, Wolff  C, Wherry  K, Stromberg  K, et al.  Two-year outcomes of leadless vs. transvenous single-chamber ventricular pacemaker in high-risk subgroups. Europace  2023;25:1041–50. PubMed PMC

Defaye  P, Biffi  M, El-Chami  M, Boveda  S, Glikson  M, Piccini  J, et al.  Cardiac pacing and lead devices management: 25 years of research at PubMed PMC

Breeman  KTN, Tjong  FVY, Miller  MA, Neuzil  P, Dukkipati  S, Knops  RE, et al.  Ten years of leadless cardiac pacing. J Am Coll Cardiol  2024;84:2131–2147. PubMed

Reddy  VY, Exner  DV, Doshi  R, Tomassoni  G, Bunch  TJ, Friedman  P, et al.  1-Year outcomes of a leadless ventricular pacemaker: the LEADLESS II (Phase 2) trial. JACC Clin Electrophysiol  2023;9:1187–9. PubMed

Ip  JE, Rashtian  M, Exner  DV, Reddy  VY, Doshi  R, Badie  N, et al.  Atrioventricular synchrony delivered by a dual-chamber leadless pacemaker system. Circulation  2024;150:439–450. PubMed PMC

Doshi  RN, Ip  JE, Defaye  P, Exner  DV, Reddy  VY, Hindricks  G, et al.  Chronic wireless communication between dual-chamber leadless pacemaker devices. Heart Rhythm  2024;S1547-5271:03446–5. PubMed

Knops  RE, Reddy  VY, Ip  JE, Doshi  R, Exner  DV, Defaye  P, et al.  A dual-chamber leadless pacemaker. N Engl J Med  2023;388:2360–2370. PubMed

Hindricks  G, Doshi  R, Defaye  P, Exner  DV, Reddy  VY, Knops  RE, et al.  Six-month electrical performance of the first dual-chamber leadless pacemaker. Heart Rhythm  2024;21:1929–1938. PubMed

Cantillon  DJ, Gambhir  A, Banker  R, Rashtian  M, Doshi  R, Badie  N, et al.  Wireless communication between paired leadless pacemakers for dual-chamber synchrony. Circ Arrhythm Electrophysiol  2022;15:e010909. PubMed

Montgomery  JA, Ellis  CR. Longevity of cardiovascular implantable electronic devices. Card Electrophysiol Clin  2018;10:1–9. PubMed

Hauser  RG, Hayes  DL, Kallinen  LM, Cannom  DS, Epstein  AE, Almquist  AK, et al.  Clinical experience with pacemaker pulse generators and transvenous leads: an 8-year prospective multicenter study. Heart Rhythm  2007;4:154–60. PubMed