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A Dual-Chamber Leadless Pacemaker

RE. Knops, VY. Reddy, 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, DJ. Cantillon, Aveir DR i2i Study Investigators

. 2023 ; 388 (25) : 2360-2370. [pub] 20230520

Jazyk angličtina Země Spojené státy americké

Typ dokumentu klinická studie, časopisecké články, multicentrická studie

Perzistentní odkaz   https://www.medvik.cz/link/bmc23011012
E-zdroje Online Plný text

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Health & Medicine (ProQuest) od 1980-01-03 do Před 3 měsíci
Family Health Database (ProQuest) od 1980-01-03 do Před 3 měsíci
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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: 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: 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: 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.).

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$a Knops, Reinoud E $u From Amsterdam University Medical Centers, Amsterdam (R.E.K., K.T.N.B.); Icahn School of Medicine at Mount Sinai (V.Y.R.) and Weill Cornell Medicine-New York Presbyterian Hospital (J.E.I.) - both in New York; HonorHealth Cardiac Arrhythmia Group, Scottsdale, AZ (R.D.); Foothills Medical Centre, Calgary, AB, Canada (D.V.E.); Centre Hospitalier Régional Universitaire Albert Michallon, Grenoble, France (P.D.); Texas Cardiac Arrhythmia Institute, Austin (R.C.); Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy (M.G.B.); Tokyo Women's Medical University, Tokyo (M.S.); Deutsches Herzzentrum der Charité, Berlin (G.H.); Na Homolce Hospital, Prague, Czech Republic (V.Y.R., P.N.); Huntington Memorial Hospital, Pasadena (M.R.), and Abbott Medical, Sylmar (J.R.N., L.G., C.H.) - both in California; and the Cleveland Clinic, Cleveland (D.J.C.)
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$a A Dual-Chamber Leadless Pacemaker / $c RE. Knops, VY. Reddy, JE. Ip, R. Doshi, DV. Exner, P. Defaye, R. Canby, MG. Bongiorni, M. Shoda, G. Hindricks, P. Neužil, M. Rashtian, KTN. Breeman, JR. Nevo, L. Ganz, C. Hubbard, DJ. Cantillon, Aveir DR i2i Study Investigators
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$a 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: 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: 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: 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.).
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$a Hindricks, Gerhard $u From Amsterdam University Medical Centers, Amsterdam (R.E.K., K.T.N.B.); Icahn School of Medicine at Mount Sinai (V.Y.R.) and Weill Cornell Medicine-New York Presbyterian Hospital (J.E.I.) - both in New York; HonorHealth Cardiac Arrhythmia Group, Scottsdale, AZ (R.D.); Foothills Medical Centre, Calgary, AB, Canada (D.V.E.); Centre Hospitalier Régional Universitaire Albert Michallon, Grenoble, France (P.D.); Texas Cardiac Arrhythmia Institute, Austin (R.C.); Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy (M.G.B.); Tokyo Women's Medical University, Tokyo (M.S.); Deutsches Herzzentrum der Charité, Berlin (G.H.); Na Homolce Hospital, Prague, Czech Republic (V.Y.R., P.N.); Huntington Memorial Hospital, Pasadena (M.R.), and Abbott Medical, Sylmar (J.R.N., L.G., C.H.) - both in California; and the Cleveland Clinic, Cleveland (D.J.C.)
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$a Rashtian, Mayer $u From Amsterdam University Medical Centers, Amsterdam (R.E.K., K.T.N.B.); Icahn School of Medicine at Mount Sinai (V.Y.R.) and Weill Cornell Medicine-New York Presbyterian Hospital (J.E.I.) - both in New York; HonorHealth Cardiac Arrhythmia Group, Scottsdale, AZ (R.D.); Foothills Medical Centre, Calgary, AB, Canada (D.V.E.); Centre Hospitalier Régional Universitaire Albert Michallon, Grenoble, France (P.D.); Texas Cardiac Arrhythmia Institute, Austin (R.C.); Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy (M.G.B.); Tokyo Women's Medical University, Tokyo (M.S.); Deutsches Herzzentrum der Charité, Berlin (G.H.); Na Homolce Hospital, Prague, Czech Republic (V.Y.R., P.N.); Huntington Memorial Hospital, Pasadena (M.R.), and Abbott Medical, Sylmar (J.R.N., L.G., C.H.) - both in California; and the Cleveland Clinic, Cleveland (D.J.C.)
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$a Breeman, Karel T N $u From Amsterdam University Medical Centers, Amsterdam (R.E.K., K.T.N.B.); Icahn School of Medicine at Mount Sinai (V.Y.R.) and Weill Cornell Medicine-New York Presbyterian Hospital (J.E.I.) - both in New York; HonorHealth Cardiac Arrhythmia Group, Scottsdale, AZ (R.D.); Foothills Medical Centre, Calgary, AB, Canada (D.V.E.); Centre Hospitalier Régional Universitaire Albert Michallon, Grenoble, France (P.D.); Texas Cardiac Arrhythmia Institute, Austin (R.C.); Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy (M.G.B.); Tokyo Women's Medical University, Tokyo (M.S.); Deutsches Herzzentrum der Charité, Berlin (G.H.); Na Homolce Hospital, Prague, Czech Republic (V.Y.R., P.N.); Huntington Memorial Hospital, Pasadena (M.R.), and Abbott Medical, Sylmar (J.R.N., L.G., C.H.) - both in California; and the Cleveland Clinic, Cleveland (D.J.C.)
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$a Hubbard, Chris $u From Amsterdam University Medical Centers, Amsterdam (R.E.K., K.T.N.B.); Icahn School of Medicine at Mount Sinai (V.Y.R.) and Weill Cornell Medicine-New York Presbyterian Hospital (J.E.I.) - both in New York; HonorHealth Cardiac Arrhythmia Group, Scottsdale, AZ (R.D.); Foothills Medical Centre, Calgary, AB, Canada (D.V.E.); Centre Hospitalier Régional Universitaire Albert Michallon, Grenoble, France (P.D.); Texas Cardiac Arrhythmia Institute, Austin (R.C.); Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy (M.G.B.); Tokyo Women's Medical University, Tokyo (M.S.); Deutsches Herzzentrum der Charité, Berlin (G.H.); Na Homolce Hospital, Prague, Czech Republic (V.Y.R., P.N.); Huntington Memorial Hospital, Pasadena (M.R.), and Abbott Medical, Sylmar (J.R.N., L.G., C.H.) - both in California; and the Cleveland Clinic, Cleveland (D.J.C.)
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$a Cantillon, Daniel J $u 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.)
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