TY - JOUR
T1 - Percutaneous implantation of an entirely intracardiac leadless pacemaker
AU - Reddy, Vivek Y.
AU - Exner, Derek V.
AU - Cantillon, Daniel J.
AU - Doshi, Rahul
AU - Bunch, T. Jared
AU - Tomassoni, Gery F.
AU - Friedman, Paul A.
AU - Estes, N. A.Mark
AU - Ip, John
AU - Niazi, Imran
AU - Plunkitt, Kenneth
AU - Banker, Rajesh
AU - Porterfield, James
AU - Ip, James E.
AU - Dukkipati, Srinivas R.
N1 - Publisher Copyright:
© 2015 Massachusetts Medical Society. All rights reserved.
PY - 2015/9/17
Y1 - 2015/9/17
N2 - BACKGROUND Cardiac pacemakers are limited by device-related complications, notably infection and problems related to pacemaker leads. We studied a miniaturized, fully selfcontained leadless pacemaker that is nonsurgically implanted in the right ventricle with the use of a catheter. METHODS In this multicenter study, we implanted an active-fixation leadless cardiac pacemaker in patients who required permanent single-chamber ventricular pacing. The primary efficacy end point was both an acceptable pacing threshold (.2.0 V at 0.4 msec) and an acceptable sensing amplitude (R wave .5.0 mV, or a value equal to or greater than the value at implantation) through 6 months. The primary safety end point was freedom from device-related serious adverse events through 6 months. In this ongoing study, the prespecified analysis of the primary end points was performed on data from the first 300 patients who completed 6 months of followup (primary cohort). The rates of the efficacy end point and safety end point were compared with performance goals (based on historical data) of 85% and 86%, respectively. Additional outcomes were assessed in all 526 patients who were enrolled as of June 2015 (the total cohort). RESULTS The leadless pacemaker was successfully implanted in 504 of the 526 patients in the total cohort (95.8%). The intention-to-treat primary efficacy end point was met in 270 of the 300 patients in the primary cohort (90.0%; 95% confidence interval [CI], 86.0 to 93.2, P = 0.007), and the primary safety end point was met in 280 of the 300 patients (93.3%; 95% CI, 89.9 to 95.9; P<0.001). At 6 months, device-related serious adverse events were observed in 6.7% of the patients; events included device dislodgement with percutaneous retrieval (in 1.7%), cardiac perforation (in 1.3%), and pacing-threshold elevation requiring percutaneous retrieval and device replacement (in 1.3%). CONCLUSIONS The leadless cardiac pacemaker met prespecified pacing and sensing requirements in the large majority of patients. Device-related serious adverse events occurred in approximately 1 in 15 patients. (Funded by St. Jude Medical; LEADLESS II ClinicalTrials .gov number, NCT02030418.).
AB - BACKGROUND Cardiac pacemakers are limited by device-related complications, notably infection and problems related to pacemaker leads. We studied a miniaturized, fully selfcontained leadless pacemaker that is nonsurgically implanted in the right ventricle with the use of a catheter. METHODS In this multicenter study, we implanted an active-fixation leadless cardiac pacemaker in patients who required permanent single-chamber ventricular pacing. The primary efficacy end point was both an acceptable pacing threshold (.2.0 V at 0.4 msec) and an acceptable sensing amplitude (R wave .5.0 mV, or a value equal to or greater than the value at implantation) through 6 months. The primary safety end point was freedom from device-related serious adverse events through 6 months. In this ongoing study, the prespecified analysis of the primary end points was performed on data from the first 300 patients who completed 6 months of followup (primary cohort). The rates of the efficacy end point and safety end point were compared with performance goals (based on historical data) of 85% and 86%, respectively. Additional outcomes were assessed in all 526 patients who were enrolled as of June 2015 (the total cohort). RESULTS The leadless pacemaker was successfully implanted in 504 of the 526 patients in the total cohort (95.8%). The intention-to-treat primary efficacy end point was met in 270 of the 300 patients in the primary cohort (90.0%; 95% confidence interval [CI], 86.0 to 93.2, P = 0.007), and the primary safety end point was met in 280 of the 300 patients (93.3%; 95% CI, 89.9 to 95.9; P<0.001). At 6 months, device-related serious adverse events were observed in 6.7% of the patients; events included device dislodgement with percutaneous retrieval (in 1.7%), cardiac perforation (in 1.3%), and pacing-threshold elevation requiring percutaneous retrieval and device replacement (in 1.3%). CONCLUSIONS The leadless cardiac pacemaker met prespecified pacing and sensing requirements in the large majority of patients. Device-related serious adverse events occurred in approximately 1 in 15 patients. (Funded by St. Jude Medical; LEADLESS II ClinicalTrials .gov number, NCT02030418.).
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U2 - 10.1056/NEJMoa1507192
DO - 10.1056/NEJMoa1507192
M3 - Article
C2 - 26321198
AN - SCOPUS:84942021935
SN - 0028-4793
VL - 373
SP - 1125
EP - 1135
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 12
ER -