• Reinoud E Knops, Vivek Y Reddy, James E Ip, Rahul Doshi, Derek V Exner, Pascal Defaye, Robert Canby, Maria Grazia Bongiorni, Morio Shoda, Gerhard Hindricks, Petr Neužil, Mayer Rashtian, Karel T N Breeman, Jordan R Nevo, Leonard Ganz, Chris Hubbard, Daniel J Cantillon, and Aveir DR i2i Study Investigators.
• From Amsterdam University Medical Centers, Amsterdam (R.E.K., K.T.N.B.); Icahn School of Medicine at Mount Sinai (V.Y.R.) and Weill Cornell Medicine-New York Presbyterian Hospital (J.E.I.) - both in New York; HonorHealth Cardiac Arrhythmia Group, Scottsdale, AZ (R.D.); Foothills Medical Centre, Calgary, AB, Canada (D.V.E.); Centre Hospitalier Régional Universitaire Albert Michallon, Grenoble, France (P.D.); Texas Cardiac Arrhythmia Institute, Austin (R.C.); Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy (M.G.B.); Tokyo Women's Medical University, Tokyo (M.S.); Deutsches Herzzentrum der Charité, Berlin (G.H.); Na Homolce Hospital, Prague, Czech Republic (V.Y.R., P.N.); Huntington Memorial Hospital, Pasadena (M.R.), and Abbott Medical, Sylmar (J.R.N., L.G., C.H.) - both in California; and the Cleveland Clinic, Cleveland (D.J.C.).
• N. Engl. J. Med. 2023 Jun 22; 388 (25): 236023702360-2370.

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, NCT05252702.).Copyright © 2023 Massachusetts Medical Society.

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